Neues aus der Welt der Antikörper und Immunother.

War gestern zu müde.  

hier noch etwas ausführlicher.

http://www.marketwatch.com/news/yhoo/...403C%2D849B%2DCDA85F73D5D7%7D

News of the deal, disclosed after Wednesday's close, was warmly received Thursday, with shares of the biotechnology giant (AMGN:
) jumping 4% to $79.99, while Abgenix (ABGX: ABGX
rocketed 28% to $21.71.

Amgen and Abgenix said they have signed a definitive merger agreement that calls for Amgen to pay $2.2 billion in cash, or $22.50 share, and to assume Abgenix's debt.

Amgen, with a market capitalization of $94.8 billion, is the largest biotechnology company in the world next to Genentech (DNA:
DNA
) , which is partially owned by Roche. Genentech had a market capitalization of $99.6 billion, as of Wednesday evening.

Amgen and Abgenix have been collaborating on developing two major drug candidates, most notably the cancer therapy panitumumab. They're also working on denosumab, a treatment for osteoporosis and bone cancer.

Amgen said it was particularly interested in panitumumab, which it says could have peak sales of more than $2 billion. The drug still must be approved by the Food and Drug Administration.

Amgen noted in its statement that by acquiring Abgenix, it will eliminate the need to pay future royalties on those drugs if and when they are approved. In early November, the companies unveiled favorable Phase III clinical data for panitumumab as a therapy for the treatment of colorectal cancer in patients who had failed on standard chemotherapy regimens.

Amgen and Abgenix expect to apply for U.S. regulatory approval of panitumumab during the first quarter of 2006. They added they also plan testing the therapy for the treatment of head and neck cancers.

That news could spell trouble for rival ImClone Systems (IMCL:
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FinancialsMore IMCLIMCL, , ) , whose antibody-based drug Erbitux is also approved to treat colorectal cancer in patients who have failed chemotherapy. Likewise, ImClone and partner Bristol-Myers Squibb (BMY: BMY
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FinancialsMore BMYBMY, , ) have been running Phase III clinical trials for Erbitux for the treatment of head and neck cancers.

Abgenix is best known for its XenoMouse technology, which allows mouse antibodies to be used as therapies in humans through genetic manipulation.

Amgen said that as a result of the merger, it expects earnings to be diluted by 5 cents to 10 cents a share in 2006 and 2007. If panitumumab is successfully launched, the deal should be accretive to dilutive earnings after 2007.

The two companies don't anticipate significant layoffs as a result of the merger, they said.

 

http://biz.yahoo.com/ap/051205/imclone_mover.html?.v=1


AP
Imclone Systems Shares Down on Report
Monday December 5, 1:50 pm ET  
Imclone Systems Shares Fall After Analyst Forecasts Stiff Competition for Erbitux


NEW YORK (AP) -- Shares of Imclone Systems Inc. slipped Monday after one analyst predicted that a competing cancer treatment may usurp U.S. market share from Erbitux in the next three to four years.
Imclone shares fell 81 cents, or 2.5 percent, to $31.69 in afternoon trading on the Nasdaq, after dropping as low as 7 percent this morning.

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In a research note, SG Cowen & Co. analyst Eric Schmidt said that he expects panitumumab, a cancer drug developed by biotech companies Amgen Inc. and Abgenix Inc., to gain U.S. approval and launch by the third quarter of 2006. Combined with favorable clinical trial data and a less frequent dosing regimen, Schmidt believes that U.S. doctors will have an incentive to adopt panitumumab over Erbitux.

The analyst cited data where tumor growth was hindered by 43 percent in patients given panitumumab, comparable to Erbitux. However, Schmidt said that panitumumab is given intravenously once every two to three weeks compared with Erbitux, which must be given once a week.

With the convenience of less frequent dosing and a lower incidence of infusion toxicities, Schmidt said that a majority of his sources estimated that panitumumab will grab 60 percent to 70 percent of the colorectal cancer treatment market in about three to four years.

Imclone sells Erbitux with marketing partner Bristol-Myers Squibb Co. Both Erbitux and panitumumab are antibodies that inhibit epidermal growth factor receptor, a protein found on the surface of many cancer cells. Annual sales of Erbitux, currently the only anti-EGFR antibody on the U.S. market, are around $450 million, and the U.S. market for the drug class is expected to grow to $750 million to $1.25 billion by 2008.

Shares of Amgen fell 46 cents to $80.32 and Abgenix shares rose 30 cents, or 2.1 percent, to $14.37 on the Nasdaq. Bristol-Myers Squibb shares dipped 8 cents to $21.80 on the New York Stock Exchange.



 

http://biz.yahoo.com/rb/051217/glaxo_cervical.html?.v=1

Reuters
Cancer vaccine has strong response in young girls
Saturday December 17, 10:18 am ET
By Ransdell Pierson


NEW YORK (Reuters) - Girls aged 10 to 14 who received GlaxoSmithKline Plc's (London:GSK.L - News) vaccine to prevent infection with the virus that causes cervical cancer had immune responses twice as strong as women 15-25 years old given the vaccine, the company said on Saturday, describing results of a late-stage trial.
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Glaxo said the first published data from a Phase III trial of its Cervarix vaccine suggest it may provide the strongest and most-prolonged protection if given to girls at very young ages, long before they encounter the sexually transmitted virus.

"The concentrations of antibodies to the virus were twice as high in the bloodstreams of the young girls," said Gary Dubin, a senior research official at Glaxo who was the lead author on the study.

Antibodies are immune-system proteins that seek out and destroy bacteria and viruses. Vaccines, by introducing the body to snippets of specific bacteria or viruses, train the body to crank out tailor-made antibodies that attack them.

Dubin said the trial was not designed to confirm actual effectiveness of the vaccine because few girls in the 10 to 14 age group are yet sexually active. Instead, he said the immune response is the best "surrogate" indicator of the vaccine's potential ability to protect them from prolonged infection with the virus.

Results of the trial were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C.

The Glaxo-financed trial, conducted in Europe and Russia, involved 158 healthy girls aged 10-14 and 458 women aged 15-25 who received three doses of the vaccine over a six month period.

Cervarix, which has not yet been submitted for regulatory approvals, is one of the most important experimental products being developed by the British drugmaker. It is expected to eventually compete with a similar Merck and Co. (NYSE:MRK - News) vaccine, Gardasil, that is already awaiting approval from U.S. and European regulators.

Like Gardasil, the Glaxo product blocks infection with two strains of human papillomavirus that are responsible for about 70 percent of cases of cervical cancer. It is the second most common fatal cancer in women.



 

http://biz.yahoo.com/ap/060103/wyeth_trubion.html?.v=1

Technologie Trubion http://www.trubion.com/products.asp
http://www.trubion.com/sci_tech_mech.asp
http://www.trubion.com/products_pipeline.asp

AP
Wyeth in Drug Partnership With Trubion
Tuesday January 3, 12:37 pm ET  
Wyeth to Pay at Least $40 Million to Trubion Pharmaceuticals As Part of Deal to Develop Drugs


NEW YORK (AP) -- Wyeth said Tuesday that will pay at least $40 million to biotech drug developer Trubion Pharmaceuticals Inc. as part of a partnership to develop therapies for immune diseases and cancer.
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Including performance-related payments, the deal could be worth up to $800 million, said Cavan Redmond, executive vice president and general manager of Wyeth's biopharmaceuticals business.

Redmond said the pact will give it access to Trubion's proprietary "SMIP" technology -- a term that stands for "small modular immuno-pharmaceuticals" and refers to the ability they give scientists to customize proteins.

Wyeth will have the exclusive rights to the specific disease targets the companies settle on, Redmond said.

Seattle-based Trubion is a small biotech company focused on developing therapies for inflammatory diseases and cancer. It was founded in 2002 by Dr. Peter Thompson, who still heads the firm.

Shares of Madison, N.J.-based Wyeth slipped 15 cents to $45.92 in midday trading on the New York Stock Exchange.



 

http://biz.yahoo.com/prnews/060103/sftu089.html?.v=39

PDL Grants Patent Licenses to Merck for Humanized Antibodies Against Two Undisclosed Antigens
Tuesday January 3, 4:00 pm ET


FREMONT, Calif., Jan. 3 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI - News) today announced that it has entered into an agreement with Merck & Co., Inc. that provides Merck with non-exclusive licenses under PDL's humanization patents for antibodies developed by Merck against two undisclosed antigens.

In exchange for the license grant, Merck will pay PDL an upfront licensing payment, development milestones and royalties on future sales of any product developed in association with this licensing agreement. Additional financial terms were not disclosed.

"The licensing of our humanized antibody technology has been the driver for a strong foundation of royalties to PDL, enabling us to advance our pipeline and more recently, build a commercial operation focused on the acute care hospital setting," said Mark McDade, Chief Executive Officer, PDL. "We are pleased that Merck joins our extensive network of licensed partners."

PDL holds various important antibody-related patents, and has entered into agreements with numerous pharmaceutical and biotechnology companies for rights covering more than 40 humanized antibodies, more than half of which are in clinical development.

About PDL

PDL is a biopharmaceutical company focused on the research, development and commercialization of novel therapies for inflammation and autoimmune diseases, acute cardiac conditions and cancer. PDL markets several biopharmaceutical products in the United States through its hospital sales force and wholly-owned subsidiary, ESP Pharma, Inc. As a leader in the development of humanized antibodies, PDL has licensed its patents to numerous pharmaceutical and biotechnology companies, some of which are now paying royalties on net sales of licensed products. Companies currently holding patent licenses for marketed products are Genentech, Inc. (Herceptin®, Xolair®, Raptiva® and Avastin(TM)); MedImmune, Inc. (Synagis®); Roche (Zenapax®); and Wyeth (Mylotarg®). Further information on PDL is available at http://www.pdl.com .

Forward-Looking Statement

The information in this press release should be considered accurate only as of the date of the release. PDL has no intention of updating and specifically disclaims any duty to update the information in this press release. This press release may contain forward-looking statements involving risks and uncertainties and PDL's actual results may differ materially from those in the forward-looking statements. Factors that may cause such differences are discussed in PDL's filings with the Securities and Exchange Commission.

NOTE: Protein Design Labs and the PDL logo are registered trademarks of Protein Design Labs, Inc. Zenapax is a registered trademark of Roche. Herceptin and Raptiva are registered trademarks and Avastin is a trademark of Genentech, Inc. Xolair is a trademark of Novartis AG. Synagis is a registered U.S. trademark of MedImmune, Inc. Mylotarg is a registered U.S. trademark of Wyeth.




--------------------------------------------------
Source: Protein Design Labs, Inc.


 

Impfstoff gegen Gebärmutterkrebs

06. Januar 2006 Gegen Krebs wird es im kommenden Jahr einen Impfstoff geben. Die aufsehenerregende Nachricht ist nicht allgemeingültig. Sie gilt aber für den Gebärmutterhalskrebs, die zweithäufigste Krebserkrankung und dritthäufigste Krebstodesursache bei Frauen. Die Entwicklung des hochwirksamen Impfstoffs birgt für die betroffenen Unternehmen angesichts der zu erwartenden Nachfrage viele Chancen: Die britische Glaxo Smith Kline (GSK) und die amerikanische Merck & Co. haben einen Markt im Visier, der schon im Jahr 2010 ein Volumen von rund 8 Milliarden Dollar erreichen soll.


An einer Zulassung durch die zuständigen Behörden in Amerika und Europa wird von Fachleuten nicht gezweifelt. Dafür sorgt zum einen die Wirksamkeit des Impfstoffs, zum anderen die hohe Zahl tragisch verlaufender Fälle, die es gibt, obwohl die Krankheit durch regelmäßige Abstriche im frühesten Stadium erkannt werden kann. Jedes Jahr sterben an Gebärmutterhalskrebs 230 000 Frauen auf der Welt.

Erkenntnisse aus Heidelberg



An dem wahrscheinlichen medizinischen und wirtschaftlichen Erfolg hat die deutsche Grundlagenforschung einen entscheidenden Anteil. Die Erkenntnisse, auf denen die Impfstoffe basieren, hatten Mitte der siebziger Jahre Forscher am Deutschen Krebsforschungszentrum (DKFZ) in Heidelberg gewonnen. Dort mußte Harald zur Hausen die damals neue Annahme, der Krebs werde durch ein Virus ausgelöst, jahrelang gegen eine große Zahl von Fachkollegen vertreten. Inzwischen sind die Erkenntnisse Allgemeingut. Und nach den Worten des GSK-Vorstandsvorsitzenden Jean-Pierre Garnier ist der Erfolg des neuen Impfstoffs, der bei den Briten Cervarix heißt, programmiert: ?Er ist hundertprozentig wirksam.? Die Zulassung in Europa, der 2007 die Markteinführung folgen soll, wird in den kommenden Monaten beantragt werden.

?In weniger als drei Jahren? auf dem Markt

Auch auf anderen Märkten der Welt sei damit zu rechnen, daß das Produkt ?in weniger als drei Jahren? auf dem Markt sei. Garnier würde es nach eigenen Worten nicht schrecken, wenn der Wettbewerber Merck & Co. mit dem Produkt schneller auf den Markt käme als Glaxo. ?Der Bedarf wird so groß, da schadet es nicht, wenn es zwei Anbieter gibt?, sagt Garnier. Tatsächlich hat Merck & Co. beziehungsweise das Gemeinschaftsunternehmen Sanofi Pasteur MSD, an dem Merck & Co. und der französische Sanofi-Aventis-Konzern zu gleichen Teilen beteiligt sind, bei der europäischen Arzneimittel-Zulassungsbehörde Emea schon im Dezember den Zulassungsantrag für seinen Impfstoff Gardasil eingereicht, der dem von Glaxo in der Wirkung grundsätzlich vergleichbar ist, auch wenn die Unternehmen gegenüber der Fachöffentlichkeit graduelle Unterschiede herausstellen.


Schneller als der Virus: Forscher zielen auf junge Mädchen
Aus deutscher Sicht ist der zu erwartende Markterfolg der ausländischen Pharmakonzerne angesichts der Saat aus der hiesigen Grundlagenforschung nicht ganz ohne bitteren Beigeschmack. "Deutschen Unternehmen haben wir das lange vergeblich angeboten", hat Otmar Wiestler, der Leiter des DKFZ, schon beklagt. Andererseits gibt es nur noch wenige große Impfstoffhersteller auf der Welt - und Sanofi Pasteur MSD hat immerhin noch Wurzeln, die sich bis zur alten Frankfurter Hoechst AG zurückverfolgen lassen.

Für Mädchen im Alter von 10 bis 15

Grundsätzlich geht es bei der Impfung um den Schutz vor dem sogenannten Humanen Papillomvirus (HPV). Da die Viren in erster Linie durch sexuelle Aktivitäten übertragen werden, gilt es als sinnvoll, Mädchen im Alter zwischen zehn und fünfzehn Jahren zu impfen. Einige Forscher regen inzwischen an, die Impfung sogar noch früher vorzunehmen, so lange nämlich, wie die Betroffenen den Arzt ohnehin noch im Rahmen ihres normalen Impfzyklus aufsuchten, um die umfassende Versorgung sicherzustellen. Sicher ist, daß der Impfstoff gegen die Erreger nichts mehr ausrichten kann, wenn sie sich nach dem ersten Geschlechtsverkehr erst einmal in den Zellen des Gebärmutterhalses eingenistet haben.

Die Impfung schützt gegen die gefährlichsten Virenstämme 16 und 18 sowie im Fall von Merck & Co. wohl auch gegen HPV 6 und HPV 11, die vor allem Genitalwarzen verursachen. 70 Prozent aller sexuell aktiven Menschen werden einmal in ihrem Leben mit HPV infiziert, bei einem Teil von ihnen kommt es zu einer chronischen Infektion. Bei Frauen kann das zu Gebärmutterhalskrebs führen. Die meisten der rund zweihundert Virustypen sind für Menschen völlig harmlos. Das gilt allerdings nicht für die Typen 6, 11, 16 und 18. ?Man weiß heute, daß mehr als 99 Prozent aller Gebärmutterhalskarzinome von HP-Viren verursacht werden?, sagt Torsten Strohmeyer, Leiter der Abteilung Forschung und Medizin bei Glaxo Smith Kline. In 70 bis 80 Prozent der Fälle seien es die Typen 16 oder 18 - und genau gegen diese Typen sei der von GSK entwickelte Impfstoff vollständig wirksam. Noch ist unklar, wie lange der für jeweils rund 800 Millionen Euro entwickelte Impfschutz anhält. Da die frühesten Patientenstudien erst vor gut sechs Jahren angelaufen sind, wird es noch einige Zeit dauern, bis man hierüber Klarheit erhält.


 

(im Tiermodell)

http://www.sciencedaily.com/releases/2005/10/051018224620.htm

Source:   University of California - Los Angeles

Date:   2005-10-19
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UCLA Researchers Identify How Antibody Blocks Prostate Cancer Growth In Animal Models
Researchers at UCLA's Jonsson Cancer Center have uncovered the mechanism by which an antibody blocks the growth of prostate cancer in animal models, a discovery that could pave the way for development of a new molecularly targeted therapy.

Related News Stories  
Drug Combo Effective For Advanced Breast Cancer (May 19, 2004) -- A pair of studies at UCLA's Jonsson Cancer Center that takes laboratory science to the patients' bedside found that combining the molecularly targeted therapy Herceptin with a specific ... > full story

UCLA Research Shows Immunotherapy May Prove A Potent New Weapon Against Prostate Cancer (May 23, 2001) -- Researchers at UCLA's Jonsson Cancer Center have shown for the first time that immunotherapy delivered via gene therapy may prove to be a potent weapon in the fight against locally advanced ... > full story

UCLA Cancer Researchers Shake Loose Hidden Biomarker (May 11, 2005) -- Using a common chemotherapy agent, researchers at UCLA's Jonsson Cancer Center and the Department of Pathology and Laboratory Medicine found a way to move an important biomarker expressed in ... > full story

PSA Level Predicts Future Prostate Growth (February 15, 2000) -- The higher a man's prostate specific antigen (PSA) level is, the more likely his prostate will continue to grow abnormally, researchers at UT Southwestern Medical Center at Dallas report. ... > full story

> more related stories


--------------------------------------------------
Related section: Health & Medicine





The antibody, called 1G8 and discovered by UCLA scientists, signals the prostate cancer cells to stop growing and die, said Dr. Robert E. Reiter, a Jonsson Cancer Center researcher and professor of urology. The antibody proved effective in several different animal models of prostate cancer, Reiter said, indicating that is could be a potent cancer fighter.

The research appears in the Oct. 15 issue of Cancer Research, a peer-reviewed journal published by the American Association for Cancer Research.

The 1G8 antibody binds to prostate stem cell antigen or PSCA, a cell surface protein discovered by Reiter that is found in about 95 percent of early stage prostate cancers and about 87 percent of prostate cancers that have spread to the bones. PSCA also is found in bladder and pancreatic cancers, Reiter and his team previously discovered, so a new targeted therapy developed from the antibody may also prove effective in battling those cancers.

"The big question with antibodies has been, how do they work?" said Reiter, senior author of the study. "Do antibodies recruit the immune system to kill the cancer or do they send a signal that tells the cancer cells to stop growing? This study shows how the antibody works, so we'll know how to apply it in the clinical setting."

The 1G8 antibody has two parts, one that binds with PSCA and one that binds with macrophages, the immune system's killer cells. Reiter and his team fragmented the antibody, separating the part that binds to PSCA and testing it alone in the animal models to see how it affected the prostate cancer cells. Even without engaging an immune response, the antibody blocked the growth of the prostate cancer cells.

"The fragments we created were unable to bind to the immune system, but they retained the same activity the whole antibody showed, so we proved that 1G8 must work by signaling the cancer cells to stop growing and die," Reiter said. "That's important because it provides a lot more information about what PSCA does and how antibodies work. It also suggests that PSCA is a very good target for therapy and that our antibody, in particular, is extremely active and binds to a region on the cell surface protein that may be an optimal target for a new treatment."

Molecularly targeted therapies are the new wave of cancer therapy, homing in on what is broken or mutated in the cancer cells and leaving the healthy cells alone. Because they only target the cancer cells, these therapies typically cause few side effects, if any, and are much easier for patients to tolerate.

The next step, Reiter said, is to test the 1G8 antibody in human clinical trials, probably in about a year.

This study is the result of years of laboratory research and is part of the Jonsson Cancer Center's Specialized Program of Research Excellence in prostate cancer, a National Cancer Institute-funded program to discover new and better ways to prevent, detect and treat prostate cancer.

"This work from start to finish is a UCLA discovery, true translational research that will go from the lab bench to the patient bedside," Reiter said.

Prostate cancer will strike more than 232,000 men in the United States this year alone, killing more than 30,350. Prostate cancer is the second leading cause of cancer death in men, according to the American Cancer Society.

###
UCLA's Jonsson Comprehensive Cancer Center comprises more than 240 researchers and clinicians engaged in cancer research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the Jonsson Cancer Center is dedicated to promoting research and translating the results into leading-edge clinical studies. In July 2005, the Jonsson Cancer Center was named the best cancer center in the western United States by U.S. News & World Report, a ranking it has held for six consecutive years.

 

Es ist zu Zeit ein Mode und Hypethema das uns aber sicher noch eine Weile beschäftigen wird. Denn die Ausbreitung schreitet voran und ein Ende ist nicht in Sicht:Die Vogelgrippe. Da hier mit Avi bereits ein potentieller Vogelgrippe Profiteur (bei dem dieses Thema aber eigentlich nur eine Nebenrolle spielt) vorgestellt wurde,
möchte ich heute einen interessanten Übersichtsartikel reinstellen. Auf w:o gibt es auch diverse Threads zu dem Thema.

 Quelle

Flu Frenzy Frames Biotechs' Futures

By Althea Chang
TheStreet.com Staff Reporter
11/15/2005 7:05 AM EST
Click here for more stories by Althea Chang


With the avian flu hysteria spreading exponentially faster than the disease itself, investors have been stocking up on Gilead Sciences (GILD:Nasdaq - commentary - research - Cramer's Take), the maker of the influenza drug Tamiflu -- the product that appears to offer the best hope against the virus.

Since the start of the year, Gilead's shares are up 49% compared with the 23% increase of the Amex Biotech Index and the almost 2% rise of the S&P 500. The company's market capitalization above $24 billion makes it one of the world's biggest biotechs.





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Recently the company has squabbled with marketing partner Roche over the rights for Tamiflu, but it remains at the forefront of any discussion about how best to prepare and protect against the bird flu.

There's little doubt that Gilead has a leading position in this fight, but rather quietly, lesser-known and often very small companies like Biocryst Pharmaceuticals (BCRX:Nasdaq - commentary - research - Cramer's Take) and AVI BioPharma (AVII:Nasdaq - commentary - research - Cramer's Take) are stepping up their own attempts at easing spreading fears of a pandemic.

The avian flu, primarily the H5N1 strain transferred from bird to bird, has been detected in more than 100 humans since the first reported bird-to-human case in Hong Kong in 1997. What's been garnering the most attention lately are worries that a mutant human-to-human version could be on the horizon.

Now that the disease has leaked westward, with cases showing up in Romania and Turkey, biotech companies are scrambling to develop their own vaccines and treatments for the disease.

Treatment Rush
Unlike vaccines, which are given as a preventative measure, antiviral drugs are meant for people already exposed to the virus. The goal with this type of treatment is to kill the invading bug before it spreads.

Besides Tamiflu, only one currently approved antiviral flu drug has been shown to work against the avian flu, Relenza from Australia's Biota. Relenza is marketed by drug giant GlaxoSmithKline (GSK:NYSE - commentary - research - Cramer's Take).

On Friday, Biota said it would support the French government's plan to build its Relenza stockpile to 9 million doses in the next two years, but there are concerns about just how much of the drug can be produced. After all, the proposed stockpile equals three times the drug's total sales since its launch in 1999, and Biota is suing GlaxoSmithKline, alleging that the company hasn't adequately supported Relenza.

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Flu Frenzy Frames Biotechs' Futures
Page 2  


Among proposed new antivirals, Biocryst Pharmaceuticals' Peramivir is on its way to clinical trials with support from the National Institutes of Health.

Peramivir, originally co-developed with Johnson & Johnson (JNJ:NYSE - commentary - research - Cramer's Take), was shown to stop the replication of the avian flu in lab mice in 2001. However, late-stage studies fell short of their goals and the partnership dissolved, with J&J saying it needed to focus its resources on higher-priority drugs.





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Biocryst has said safety wasn't a factor in the pact falling apart, and investor hopes are running high that Peramivir might have a future after all. Biocryst shares have tripled in recent months to $11.30 from a 52-week low of $3.68.

Another antiviral drug developer, AVI BioPharma, is targeting several strains of the avian flu, as well as the common flu. AVI says its drug kills viruses by targeting a specific chunk of genetic code common in several types of influenza and that are critical to virus survival. The drugs were effective in early studies, and could enter animal studies as early as the end of the year, AVI Chief Executive Denis Burger said in an interview.

AVI, though small with a market cap around $160 million, has seen its shares run up 66% from the beginning of September, closing Monday at $3.69.

Protective Approach
Elsewhere, Novavax (NVAX:Nasdaq - commentary - research - Cramer's Take), which has a $130 million market cap, said it's focusing its resources to develop its own bird flu vaccine. Earlier this month, the company contended that it has a "compelling solution" to a pandemic and can produce large quantities of vaccine in a short period of time.

The company says a planned secondary stock offering will help fund the production, and New Jersey-based firm Wave Biotech will manufacture it.

Another tiny firm, Generex Biotechnology (GNBT:Nasdaq - commentary - research - Cramer's Take) (market cap $44 million) is looking to co-develop its avian influenza vaccine in China, and has proposed partnerships with the Harbin Veterinary Research Institute, Sinovac Biotech and Shanghai Institutes for Biological Sciences.

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Flu Frenzy Frames Biotechs' Futures
Page 3  


Of course, Gilead's Tamiflu has easily received the most attention. Tamiflu has been proven effective in treating the avian flu in humans, and it's already approved by the Food and Drug Administration to treat common strains of influenza. But Gilead says Roche has failed to adequately market Tamiflu, and the companies are involved in arbitration to decide the rights to the drug.

Roche has the sole marketing rights to the drug Gilead developed. Where it could get worrisome for these two companies, from an investment standpoint at least, is the fact that Taiwanese researchers and Indian generic drug company Cipla claim to have copied the drug. Cipla has said it plans to manufacture it, despite a possible court showdown with Roche.





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Initially, Roche had refused to allow another company to manufacture Tamiflu, but that's changed amid growing worry and pressure from various regulators. Roche now says it's in discussions with eight companies, including large generic-drug makers, along with the governments of Taiwan and Vietnam.

Roche estimates it will have the capacity to produce 300 million doses of Tamiflu a year by 2006, or 10 times its 2004 capacity. The company expects to select potential partners for more detailed production discussions by the end of this month.

 

http://content.nejm.org/cgi/content/full/353/25/2667
und ausserdem ist Tamiflu längst weidlich diskutiert worden unter Roche!  

http://yahoo.businessweek.com/magazine/content/06_03/b3967104.htm

SPECIAL REPORT

Crossing The Gene Barrier
On the frontiers of biotech, two scientists are mingling the genetic materials of man and beast in new ways. The hoped-for outcome: Radical treatments for some of mankind's most intractable ailments


Slide Show >>Goats throughout history have been symbols of vitality and cunning, and treasured for their silky fur and nutrient-rich milk. But Sweetheart, a brown-striped goat with soulful eyes, has a secret that could elevate her far above this illustrious legacy. Named for her laid-back disposition, she has a single human gene in the twined strands of her DNA that enables her to produce a life-saving drug in her milk. It's a protein that's normally found in human blood.

In ancient times, the Greeks revered the god Pan -- part-man, part-goat -- who defended Athens against the Persians. Today, the dash of humanity imbedded in Sweetheart and 59 other goats at a central Massachusetts farm could provide a different but equally vital line of defense. Some people don't make enough of the protein in their livers, explains Harry M. Meade, the chief scientist at the company that created her. That raises the risk they'll suffer fatal blood clots during surgery. Others, such as burn victims and heart surgery patients, need a bit more of the protein to speed their recovery. If regulators in Europe approve Sweetheart's elixir in February, as expected, it's likely to be the first drug on the market derived from the milk of a part-human "chimera" -- a creature that bears the cells of two or more species.

A Tale of Two Scientists
Three thousand miles away, scientist Nils Lonberg reaches into a cage and scoops up a different sort of chimera. It looks like a subway-variety mouse, but its tiny body cradles a partial replica of one of the most intricate systems known to biology: a human immune system. This whiskered fur ball has the extraordinary ability to produce disease-fighting antibodies in its cells that can be harvested and turned into drugs. As the creature sniffs the hand of the scientist that invented her, the 49-year-old Lonberg responds as if he is encountering the animal for the first time. "I find this amazing," he says. The challenge of engineering this rodent is comparable to building a towering skyscraper, he says: "It's amazing that people can create something of this complexity."

This is the story of two scientists, Meade and Lonberg, who are toiling on the fringes of biotechnology. Their paths crossed 20 years ago, setting them on a quest to alter the age-old partnership between man and beast by mixing genes to concoct new medicines. Since then the two have pursued their goal on separate but parallel tracks. Meade, 59, is now chief scientific officer of Framingham (Mass.)-based GTC Biotherapeutics (GTCB ), which created Sweetheart. Lonberg is scientific director at Medarex Inc. (MEDX ), which is taking a lead in commercializing transgenic mice.

In the business of biotech, chimeras are about as close to science fiction as you can get. People have been crossing critters for centuries -- yielding everything from mules to labradoodles. But jumping the gene barrier by giving animals copies of human genes is more sensational. These creatures look, act, and smell like animals, yet their cellular machinery conceals unique biochemical capabilities. Already, 50 biotech and pharmaceutical companies are using mice from Medarex to develop treatments for terrible diseases -- from malignant melanoma to lymphoma to lupus. And GTC's goats may become factories for drugs that are too complex to produce any other way.

Yet as promising as these developments are, Meade and Lonberg strive to hold their optimism in check. Both spent years confronting the skepticism of other scientists, and even derision. Today, GTC and Medarex are burning through cash and investors are getting impatient. Other transgenics companies have shriveled and died. As drug regulators start issuing their rulings in coming months, the two men will learn whether their life's work will enrich mankind's supply of drugs or if their companies will sink into oblivion like so many other promising biotechs.

The saga of the goat and the mouse began in 1984, in a lab at Biogen Inc. in Cambridge, Mass. Meade and Lonberg were brainstorming how to manufacture a human protein that looked promising as a treatment for blood clots. They pulled an all-nighter devising a scheme for slipping human genes into the DNA of animals and then milking them to harvest the drug. The pair thought it was a brilliant idea, but few of their colleagues agreed. When Lonberg described it the next day to then-CEO Walter Gilbert and his management team, they nearly laughed the young scientist out of the room. "Gilbert looked at me and said, 'how about making it in goose eggs? You could have the goose who laid the golden egg,"' recalls Lonberg.

In fact, Meade points out, companies are now trying to do exactly that -- extract drugs from transgenic chicken eggs. "It sounds incredibly simple," Meade says, "but everything's in the details."

When Meade and Lonberg first began to tackle those details, they found themselves cast in the role of mad scientists. Having left Biogen in 1985, Lonberg was studying transgenics at Memorial Sloan-Kettering Cancer Center in New York. With the help of Meade, who often visited the lab, he succeeded in rejiggering the DNA of mice so they could produce human proteins in their milk. The scientists then rented a woman's breast pump from a pharmacy in New York and rigged it up to fit their tiny research subjects. "I remember them using this pipetting apparatus and applying it to the mouse nipples," laughs Elizabeth Lacy, Lonberg's former adviser at the cancer center. When Meade tried to return the borrowed breast pump a year later, the pharmacist was so shocked to hear what it had been used for that he refused to take it back.

Meade and Lonberg seemed like biotech's version of the Odd Couple. Meade, a jock who sometimes bikes 26 miles to work, once attracted a crowd at Biogen by demonstrating the moves he had learned in a break-dancing class. He wore his bike helmet to protect his head as he spun on the floor. The display startled Lonberg, who once ditched a required physical education credit at Reed College. It cost him his bachelor's degree, but it was a satisfying "act of defiance," Lonberg says. Having already been admitted to Harvard's PhD program in molecular biology, Lonberg called the head of the department to make sure the missing degree wouldn't matter.

Differences aside, Meade and Lonberg played off each other's strengths. Meade, the elder, passed on his knowledge of biochemistry and genetics to the young student. And as Lonberg focused his postgraduate studies on the then-embryonic field of transgenics, he taught Meade the intricacies of stitching human genes into animals. Together they co-authored the first issued patent on extracting drugs from milk in 1989.

Contemplating the gallons of milk necessary to make a drug, Meade planned to apply the technology to cows. Having grown up on a dairy farm outside Pittsburgh, he knew his research subject intimately. When the young Meade didn't have his nose buried in a science textbook, he was milking the family's herd and hanging out with the 4-H Club and the Future Farmers of America. "I was probably the only person who figured out butterfat content using a slide rule," Meade jokes.

At Biogen, Meade wasn't always confident that his bosses supported his plan to marry biotech with bovines. During analyst meetings, he recalls, "I had this feeling they were trotting me out for comic relief." He didn't feel truly in his element until he was managing research at GTC, a company devoted mostly to goat/human chimeras.

The Dolly Difference
In principal, giving Sweetheart and the rest of her herd the machinery to make human proteins is basic college biology. It's a matter of inserting a copy of a single human gene into her DNA and programming it to turn on in her mammary gland. But in the early days, GTC's method for tweaking the goat's DNA was so clumsy that only 5% of the kids were born carrying the human gene. Over the years, a string of scientific breakthroughs enhanced the process. Topping the list was the sheep called Dolly. After the Roslin Institute in Scotland cloned the now-famous sheep, GTC adapted the technology to its newest breeds of drugmaking goats -- boosting the success rate to nearly 100%.

Investors at first went wild over GTC's goats. In the late 1990s demand for biotech drugs was skyrocketing, and drugmakers faced a dire manufacturing crunch. GTC promised virtually unlimited capacity at a fraction of the $500 million it costs to build the typical biotech factory. It made perfect sense: You need more drugs? Breed more goats. Even some majors like Bristol-Myers Squibb (BMY ) and Johnson & Johnson (JNJ ) began talking with GTC. Investors piled in, pumping GTC's stock up to $50, which gave the unprofitable biotech a market value of more than $1 billion.

This wasn't sustainable. Drugmakers gradually improved the traditional way of making biotech proteins -- in cells housed in giant steel vats. Fears of a biotech manufacturing shortage subsided, and one by one, GTC's deep-pocketed partners pulled out. Investors bailed, too, driving GTC's stock down to single-digit territory. "You don't get many swings at the bat in this business," Meade says. "People lost faith."

But Meade himself remained steadfast. He was certain that his goats could correct a major shortcoming of steel vats -- the latter are terrible at churning out complex proteins. Sweetheart's protein, called antithrombin, is one such molecule. And to this day it can only be harvested from donated human blood, which is often in short supply. So, armed with $75.7 million from a stock offering GTC pulled off during the 2000 market boom, the company charged ahead on its own. Executives at GTC's former parent Genzyme Corp. (GENZ ) were impressed that Meade and his team never seemed to get discouraged. "There were enormous challenges. Some people thought they were crazy," says James A. Geraghty, senior vice-president at Genzyme, which still owns 9.6% of GTC's stock. "But crazy is not that different from passionate."

For Meade's old partner, Lonberg, passion has always come in a small package: mice. As a boy, in Arlington, Va., he took two gerbils his grandmother gave him and bred them into a colony of 56. And Lonberg met his scientist wife in a lab at Sloan-Kettering. "We literally met in a mouse house," he says. He remembers the two of them attending a transgenics conference in 1989, where a scientist announced a new technique for knocking out certain genes in mice in order to make them more like people. "Everyone got up and applauded," he says.

That same year, Lonberg joined a company with an ambitious plan to make mice more like men. Scientists in the early 1980s had already figured out how to produce human proteins in mice. But there was one snag: Resulting products would have bits of mouse protein in them, which would make people sick with side effects.

Ensconced at his new company, called GenPharm, he created and then bred two different varieties of gene-modified mice. One had a disabled immune system -- it couldn't produce any of its own antibodies. The other bore the genes that are responsible for making human antibodies. Immunologically speaking, the offspring of these two rodents is more human than rodent. Provoked by a disease-causing agent -- bits of a human tumor, for example -- "their cells produce antibodies in exactly the right form to go into humans," Lonberg says. The antibodies can then be mass-produced as drugs.

Triumph to Turmoil
What should have been a triumph led instead to a period of turmoil. After Lonberg trumpeted his mice at a 1993 conference, rival Cell Genesys (CEGE ) filed suit against GenPharm, claiming theft of trade secrets. GenPharm answered with claims of patent infringement. As the battle dragged on, chewing up the company's scarce capital, GenPharm was forced to pare down from 110 employees to seven. Still, amid general despair, Lonberg was determined to keep the technology alive. "We were so sad to see our good team falling apart," says former co-worker Frank Pieper. "One day Nils took us aside and spent a great deal of time explaining why GenPharm was right and how he was going to make sure we came out as winners." Three years later the parties settled. Cell Genesys (now called Abgenix (ABGX )) dropped the theft charge and paid GenPharm $40 million to cross-license its patents.

Once the legal hurdles were cleared, other biotechs started approaching Lonberg. One company that was particularly interested was Medarex, which like hundreds of other biotechs was pursuing antibodies, but without a distinctive technology that could quickly identify and generate the most promising molecules. "We needed a tool," recalls Donald L. Drakeman, CEO of Medarex. "Nils's transgenic mice gave us that." Medarex bought GenPharm in 1997 for $62.2 million in stock. Around this time, the stock market once again began to smile on biotech after a long slump. In March, 2000, Medarex made a smart move, just as GTC had done. It raised $388 million in a stock offering. "This changed Medarex," Lonberg says, by allowing it to build a research facility.

As if to remind Lonberg of his ongoing battle to conquer transgenics, a giant framed photo of a mouse stares down at the scientist in his Milpitas (Calif.) lab. Down the hall, more than 6,000 mice live in pathogen-proof rooms, hidden behind double doors. The scientists who wish to enter must first take showers and don cloth gowns from head to toe, to avoid passing along their germs to the valuable and pampered rodents.

But what if the protected mice were the ones that posed the threat? In Greek mythology, the chimera was a hybrid beast that breathed fire and foreshadowed natural disasters. Some experts take that as a metaphor. They worry that transplanted human genes -- particularly in farm animals -- could "leak" into the food supply, say, if a genetically modified critter were to run off and mate with a non-GM cousin. One of the last things you'd want is a bit of human protein -- one that could make healthy people sick -- turning up in the goat cheese that's sprinkled on top of your salad. Some people call this the "ick" factor. "Even when you have an ethical rationale for doing this work, people find it troubling," says Michigan State University philosophy professor Paul B. Thompson.

It would help if the regulations meant to prevent nightmarish accidents were actually enforced. Critics blast the Food & Drug Administration and U.S. Agriculture Dept. for failing to tighten regulations that will keep transgenic animals used in health care out of the food supply. Lobbying groups such as the Union of Concerned Scientists (UCS) were dismayed in 2002 when the University of Illinois at Urbana-Champaign sent 386 pigs used in transgenic experiments to slaughter. Only one animal had transgenes, but none of the pigs had been approved by the FDA for commercial use. (None ended up in the food supply.)

To avoid mistakes, GTC has rigorous security protocols. And the farm is hidden on a back road with no signs, to foil animal-rights vigilantes who might want to "liberate" the goats. GTC also designed nibble-proof pens, recognizing that goats have an uncanny ability to open latched doors with their teeth.

Even with such careful measures, there are questions that can't be corralled in electronic fences. As researchers amble further out on biology's frontier, they are forcing society to confront what it means to be human, and to consider whether scientists are changing that very definition by so freely mixing the genes of humans and beasts.

The pioneers of transgenics regard such metaphysical debates as random noise. They argue that a human being isn't defined by individual genes -- most of which are common to all animals. "DNA does not contain the soul or consciousness of a person," Meade declares.

For now, he and Lonberg are focusing on a more urgent matter: persuading regulators that their drugs are safe and effective. Their latest clinical-trial data are compelling, the scientists say, but now they are stuck in a waiting game. In September, European regulators said they needed more time to decide whether to approve goat-made antithrombin -- disappointing investors who had hoped for an October ruling. CEO Geoffrey F. Cox takes the delays in stride. "Making transgenic animals is very clever, but it's not a business," he says. "We've got work to do." If GTC succeeds, he says antithrombin could someday bring in more than $500 million in annual sales.

On a crisp October morning, the normally casual Meade arrives for work dressed in a suit. It's his turn to talk strategy with the board of directors. These days, the discussion is no longer confined to antithrombin. GTC has developed herds to produce other drugs, such as a malaria vaccine and a treatment to shrink solid tumors. Even though Meade is approaching the age when others might prefer golf courses to goat farms, he's too energized by the potential of transgenics to leave it behind. One day, he says, he'd like to make goats that can churn out treatments for infectious diseases such as HIV. "The first 20 years of my life I worked on a farm milking cows," Meade says. "The last 20 years I've spent trying to make [transgenics] work. It all kind of ties in."

As GTC inches toward approval of its first goat-made drug, other companies are showing interest in the technology. In July, Boston-based Merrimack Pharmaceuticals expanded a partnership with GTC, which has developed goats that produce Merrimack's experimental rheumatoid arthritis treatment. "We tried standard production technologies, but they didn't allow us to make it in a commercially viable way," says Robert Mulroy, CEO of Merrimack, who estimates that the drug will address a $4 billion market.

Medarex can also point to some progress. Of the 40 or so experimental drugs that have been derived from humanized mice, 27 come from Medarex' animals and the rest from rival Abgenix. In November, Abgenix announced that a cancer treatment developed with giant Amgen (AMGN ) shrank colon tumors 46% in a late-stage trial. A month later, Amgen scooped up Abgenix for $2.2 billion.

These developments also vindicate Medarex's work in humanized mice -- and it's own close partnership with Amgen. The biotech giant is developing three drugs using Medarex's mice. "It's a highly productive relationship and we anticipate doing further business with Medarex," says Scott Foraker, vice-president of licensing for Amgen. Will Amgen swallow Medarex, too? "We are continually evaluating acquisition and licensing opportunities," he says.

Last September, Pfizer Inc. (PFE ) took a stake in Medarex and paid $80 million up front for rights to as many as 50 antibodies over the next decade. The deal could ultimately bring Medarex $400 million. And Medarex and Bristol are co-developing a drug to treat metastatic melanoma. To remind himself how far he and his mice have come, Lonberg often pulls up before-and-after X-rays of a patient who received the drug. "He had 31 lung tumors. They're all gone," Lonberg says. The proof won't come until a pivotal, late-stage trial is completed next year, but Bristol is thinking about using the mice on more drugs.

Lonberg and Meade often catch up on the phone and at conferences. The two share a dream of making a drug together -- first generating a life-saving molecule in Lonberg's mice, then mass-producing it in Meade's goats. "Harry and I agree it would be a wonderful collaboration," Lonberg says. And a fitting epilogue to a 20-year history of transgenic beasts and human health care.
 

http://biz.yahoo.com/iw/060109/0105586.html

Press Release Source: CancerVax


CancerVax and Micromet Announce Merger Agreement
Monday January 9, 3:01 am ET


Conference Call Scheduled for January 9, 2006, at 9:00 AM Eastern / 03:00 PM Central European Time


CARLSBAD, CA and MUNICH, GERMANY--(MARKET WIRE)--Jan 9, 2006 -- CancerVax Corporation (NasdaqNM:CNVX - News), a biotechnology company focused on the research, development and commercialization of novel biological products for the treatment of cancer, and Micromet AG, one of the leading privately held European biopharmaceutical companies focused on the development of antibody-based drugs, announced today the signing of a definitive merger agreement. The merger is expected to create a transatlantic, NASDAQ-listed company with a highly differentiated drug development pipeline focused on oncology, autoimmune and inflammatory diseases, and a strong, proprietary technology base for the development of antibody-based product candidates.

"We believe that the proposed merger of CancerVax and Micromet is consistent with our objective of maximizing value for our stockholders, and will result in an organization with a robust pipeline of drug candidates as well as significant experience in drug discovery and development," said David F. Hale, President and CEO of CancerVax Corporation.

"This transaction will allow Micromet to access U.S. capital markets, which is essential in our efforts to accelerate the development of our novel, antibody-based drug compounds based on our proprietary BiTE(TM), or bi-specific T cell engager, and single-chain antibody drug development platforms," said Christian Itin, Ph.D., CEO of Micromet. "It also strengthens our management team and financial position, allows us to leverage CancerVax's existing U.S. public company infrastructure, and adds to our product development portfolio."

The merged company will have a substantial product pipeline, with two compounds in clinical development in three major cancer indications and several preclinical and research-stage product candidates.

Product Candidate    Indication         Development Stage   Collaboration

MT201                Metastatic Breast  Phase 2             Serono
Adecatumumab         Cancer
(human antibody)     Prostate Cancer

MT103                Non-Hodgkin's      Phase 1             MedImmune, Inc.
(BiTE?)              Lymphoma (NHL)

MT110                Solid Tumors       Pre-clinical        ---
(BiTE?)

MT203                Inflammatory       Pre-clinical        ---
(human antibody)     Diseases

D93                  Solid Tumors       Pre-clinical        ---
(humanized antibody)
Details of the Proposed Transaction

Under the terms of the merger agreement, CancerVax will issue, and Micromet stockholders will receive, shares of CancerVax stock such that Micromet stockholders will own approximately 67.5 percent of the combined company, on a pro forma basis, and CancerVax stockholders will own approximately 32.5 percent. It is anticipated that, on a pro forma basis, cash, cash equivalents and securities available-for-sale for the combined Companies as of December 31, 2005 will be between $57 million and $60 million. The merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the U.S. Internal Revenue Code of 1986, as amended. The merger agreement has been approved by both Boards of Directors and will need to be approved by each company's stockholders.

CancerVax expects to file a Form S-4 and related proxy statement/prospectus with the U.S. Securities and Exchange Commission and any other necessary government filings in the coming weeks. Depending on the review process of the agencies, the Companies would expect their respective stockholder votes to occur in the second quarter of 2006. Upon closing of the transaction, the Company's shares are expected to continue to trade on the NASDAQ National Market. CancerVax will be renamed as Micromet, Inc., and application will be made to NASDAQ to change the ticker symbol to "MITI." Piper Jaffray & Co. served as financial advisor and Latham and Watkins LLP as legal advisor to CancerVax. Cooley Godward LLP served as legal advisor to Micromet.

Management and Organization

Following the closing, the merged Company's U.S. headquarters will be in Carlsbad, CA, while the Company's German headquarters will remain in Munich, Germany. Research and development activities will be consolidated in Munich.

David F. Hale, currently President and Chief Executive Officer of CancerVax, will become Chairman of the Board of Directors of the merged company. Micromet's Chief Executive Officer, Christian Itin, will become President and CEO and serve on the Board of Directors. Patrick Baeuerle, currently Chief Scientific Officer of Micromet, will become CSO of the combined entity. CancerVax's Chief Financial Officer, William R. LaRue, will serve as CFO of the merged company. Gregor Mirow, Micromet's Chief Financial and Chief Operating Officer, will be COO, and Hazel M. Aker, CancerVax's General Counsel, will continue to serve as General Counsel. The combined company's Board of Directors will consist of five current Micromet directors, including one director who is also currently a director of CancerVax, three other CancerVax directors and a ninth director to be named by Micromet prior to the merger.

Outlook for 2006

Following the merger, the Company plans to focus its resources on accelerating the development of its clinical-stage product development programs and leveraging its strong R&D base and pipeline-generating capabilities related to human antibodies, BiTE(TM) molecules and single-chain antibodies. The Company also plans to continue to build on Micromet's track record of successfully establishing drug development collaborations with major pharmaceutical companies, while retaining substantial commercial rights.

Anticipated milestones for the merged Company in 2006 include:

--  Closing the merger transaction in the second quarter;
--  Phase 2 clinical trial results for MT201 in patients with metastatic
   breast cancer and in patients with prostate cancer;
--  Phase 1 results for MT103 in the treatment of patients with NHL;
--  Filing of an investigational new drug application in the first quarter
   to initiate clinical trials with D93; and
--  Continuing to pursue partnering opportunities.
MT201 - Adecatumumab

Micromet's lead product candidate, MT201, is a recombinant human monoclonal antibody of the IgG1 subclass with a binding specificity to epithelial cell adhesion molecule (Ep-CAM). Ep-CAM is over-expressed with high frequency on most solid tumor types, including prostate, breast, colon, gastric, ovarian and lung cancer. MT201 is in Phase 2 clinical trials in patients with prostate cancer and metastatic breast cancer. In addition, MT201 is being evaluated as a combination therapy with Taxotere® (docetaxel) in a Phase I clinical trial in patients with metastatic breast cancer. The FDA has approved an investigational new drug application for MT201 for the treatment of patients with metastatic breast cancer.

In December 2004, Micromet announced an exclusive worldwide collaboration and license agreement with Serono, a Swiss corporation, for the development and commercialization of MT201. Micromet received an initial license fee of US$10 million and may receive additional milestone payments of up to US$138 million if the product is successfully developed and registered worldwide in three or more indications. In addition, Micromet may receive undisclosed royalties based on net sales of the product. Under certain terms and conditions, Micromet may elect to share in the development and commercialization of the product in the U.S. and E.U. in exchange for a share of profits.

MT103

Micromet's other leading product candidate, MT103, is being studied in a European Phase 1 clinical trial. MT103 represents a new class of therapeutics that may be capable of instructing the patients' own T cells (a very potent type of killer cell) to repeatedly eliminate tumor cells. This technology is called BiTE(TM) (bi-specific T cell engager). MT103 binds to CD19 on B cells, a cell surface antigen.

In June 2003, Micromet announced an agreement to jointly develop MT103 with MedImmune, Inc. Under the terms of the agreement, Micromet would receive milestone payments based on the successful development, filing, registration and marketing of MT103, as well as royalties on MedImmune's North American sales of the product. Micromet retained all rights to the product candidate outside of North America.

D93

CancerVax's D93 is a humanized, monoclonal antibody being studied for the treatment of solid tumors, which has been shown to selectively bind to denatured or remodeled protein in diseased or damaged tissues, but not to native collagen in the extra-cellular matrix of healthy tissue. D93 has demonstrated the ability to selectively bind to denatured collagen targets in colon, melanoma, lung, and breast cancer tumors grown in xenogeneic mouse models. The Company expects to submit an investigational new drug application for D93 to the FDA in the first quarter of 2006, and plans to initiate the first clinical trial for D93 later in 2006.

Micromet's BiTE(TM) Technology

Micromet's BiTE(TM) technology represents a novel therapeutic modality with the potential to develop antibody-based products to improve the treatment of diseases that currently lack satisfactory treatment options and that are resistant or refractory to standard therapies. BiTE(TM) molecules constitute a novel class of bi-specific antibodies that appear to be unique in their ability to activate the body's killer T cells against target cells. The proposed mechanism of action of Micromet's BiTE(TM) technology involves the activation of the available T cells in a patient's body, regardless of their specificity. This approach may have advantages, since in cancer therapy, patient-derived cancer tissue has to be recognized as "foreign" and eliminated by the patient's T cells. In many cases, tumors evade the recognition mechanisms used by T cells, in particular, and thus cannot be controlled by the patient's immune system. In summary, BiTE(TM) molecules are designed to provide each T cell with the ability to circumvent a number of tumor cell defense mechanisms.

Single-Chain Antibodies

Single-chain antibodies, which are used in the construction of BiTE(TM) product candidates, have demonstrated potential as therapeutics, diagnostics and as research tools. Single-chain antibodies comprise the antigen-binding site of antibodies engineered as a single protein. Under an agreement with Enzon Pharmaceuticals, Inc. Micromet is the exclusive licensor of the two companies' combined intellectual property estate in the field of single-chain antibody technology. Current licensees include Alexion Pharmaceuticals, Alligator Bioscience, Amersham Pharmacia, Arizeke Pharmaceuticals, Baxter Healthcare Corporation, BioInvent International AB, Bristol-Myers Squibb Company, Cambridge Antibody Technology, UCB Pharma, Crucell, EvoGenix, ESBATech, Invitrogen, MorphoSys, Merck & Co., Neoprobe Corporation and Xoma Corporation.

Conference Call Monday, January 9, at 9:00 AM Eastern Time / 03:00 PM Central European Time

CancerVax and Micromet will host a joint conference call on Monday, January 9, to discuss the planned merger and its business overview at 9:00 a.m. Eastern Time. A live audio webcast of management's presentation will be available at http://ir.cancervax.com. Alternatively, callers may participate in the conference call by dialing (866) 700-7173 (domestic) or (617) 213-8838 (international). The passcode for the call is 36272047. Following the call, the webcast will be archived on the investor relations section of the CancerVax website.

About CancerVax Corporation (www.cancervax.com)

CancerVax Corporation is a biotechnology company focused on the research, development and commercialization of novel biological products for the treatment and control of cancer. The Company's leading product candidate is D93, an anti-angiogenic, humanized, monoclonal antibody. CancerVax plans to file an investigational new drug application for clinical trials of D93 in the first quarter of 2006. Upon the consummation of the merger, the Company intends to focus on the development of antibody-based product candidates for the treatment of cancer and inflammatory and autoimmune diseases. As a result, CancerVax is actively seeking to sublicense its rights to its three licensed product candidates that target the epidermal growth factor receptor signalling pathway.

About Micromet (www.micromet.de)

Micromet AG is a private Munich, Germany-based biotechnology company with a focus on the development of novel, proprietary antibody-based products for cancer and inflammatory and autoimmune diseases. Two product candidates are currently in clinical trials. MT201, a recombinant human monoclonal antibody is being evaluated in Phase 2 clinical trials for the treatment of certain solid tumors. MT103 is being studied in a Phase 1 clinical trial. The Company has established a powerful drug development platform based on its BiTE(TM) technology, a unique drug format that leverages the cytotoxic potential of T cells, the most powerful 'killer cells' of the human immune system. Micromet has integrated infrastructure and expertise in all disciplines of drug design and development. The Company has attracted both top-tier life science investors and collaborators, such as MedImmune, Inc. and Serono.

Forward-Looking Statements

This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the proposed transaction, the efficacy, safety, and intended utilization of the companies' respective product candidates, the conduct and results of future clinical trials, and plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that CancerVax and Micromet may not be able to complete the proposed transaction, the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that CancerVax and Micromet will not obtain approval to market their respective products, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. The transaction is subject to customary closing conditions, including approval of CancerVax's and Micromet's stockholders. These factors and others are more fully discussed in CancerVax's periodic reports and other filings with the SEC.

Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. CancerVax undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Additional Information about the Merger and Where to Find It

In connection with the proposed transaction described herein, CancerVax will file a registration statement that contains a proxy statement/prospectus with the SEC. Investors and security holders of CancerVax and Micromet are urged to read the proxy statement/prospectus (including any amendments or supplements to the proxy statement/prospectus) regarding the proposed transaction when it becomes available because it will contain important information about CancerVax, Micromet and the proposed transaction. CancerVax's stockholders will be able to obtain a copy of the proxy statement/prospectus, as well as other filings containing information about CancerVax and Micromet, without charge, at the SEC's Internet site (http://www.sec.gov). Copies of the proxy statement/prospectus and the filings with the SEC that will be incorporated by reference in the proxy statement/prospectus can also be obtained, without charge, by directing a request to CancerVax Corporation, 2110 Rutherford Road, Carlsbad, CA 92008, Attention: Investor Relations, Telephone: (760) 494-4200.

Participants in the Solicitation

CancerVax and its directors and executive officers and Micromet and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of CancerVax in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger transaction will be included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of CancerVax is also included in CancerVax's proxy statement for its 2005 Annual Meeting of Stockholders, which was filed with the SEC on April 28, 2005. This document is available free of charge at the SEC's web site (www.sec.gov) and from Investor Relations at CancerVax at the address described above.



Contact:
         Contact for CancerVax Corporation
    William R. La Rue
    SVP & Chief Financial Officer
    +1 760-494-4200
    Email Contact
    http://www.cancervax.com
     
    Contacts for Micromet
    Evelyn Wolf (media)
    +49 89 895277-220
    Email Contact
     
    Ines-Regina Buth (investors)
    +49 89 895277-221
    Email Contact
    http://www.micromet.de
     

 

http://www.nature.com/news/2006/060109/full/060109-14.html


Bird flu mutation sparks concern
Genetic tweak makes virus favour human nose and throat.
Declan Butler



© WHO

Researchers have sequenced the bird flu viruses that killed two people in Turkey in early January, and say that one of them contains a worrying mutation.

This genetic tweak can make the H5N1 virus more adapted to humans than to birds, and more adapted to the nose and throat than to the lungs. This latter effect could help to increase the chances of bird flu being transmitted between people, researchers say.

They add that many more mutations would probably be necessary before the virus is capable of sparking a full-blown pandemic, in which disease spreads like wild fire from person to person.

The samples of H5N1 virus, taken from the first two victims who died of bird flu in Turkey, were sequenced at a World Health Organisation (WHO) collaborating centre at the National Institute for Medical Research in London, UK. The results were announced on Thursday 12 January, along with confirmation of two new cases: bird flu has now also struck Sanliurfa Province, near Turkey's southern border with Syria, and Siirt Province, in the eastern part of Turkey.

The total number of reported human cases has now reached 18 in less than two weeks, three of which have been fatal.

In a bind

The WHO has released details of only one of the mutations found in the viruses. This genetic change results in a substitution of the amino acid serine by another amino acid, asparagine, at a specific position in one of the virus's proteins; a protein that helps the flu virus to bind to receptors on host cells.

This mutation has been observed twice before: in a father and son in Hong Kong in February 2003, and in one fatal case in Vietnam last year. It is known to increase the affinity of the virus for human receptors over poultry ones.

Until samples from the remaining cases are sequenced over the coming week, it is unknown how many of these came from viruses with the same mutation. If many prove to have the same tweak, this may help to account for the relatively large size of Turkey's rapid outbreak. The WHO's current explanation for the spate of cases is simply that people are bringing chickens into their homes during the harsh Turkish winter.

Nose and throat

The mutation also has a secondary effect, which may be more worrying.

There are two subtypes of receptors in the human respiratory tract: alpha 2.3, which occurs mainly in the lower respiratory tract; and alpha 2.6, which occurs mainly in the nose and throat. Human flu viruses typically show a preference for the 2.6 receptors, whereas H5N1 strains typically prefer 2.3.

This is good news for those worried about bird flu, since human-to-human transmission is thought to be more likely via droplets coughed from the nose and throat than from infections lower down. But the mutation found in the Turkey viruses is also known to be able to increase the affinity for H5N1 to the 2.6 receptors, points out Sylvie van der Werf, head of the Laboratory of Molecular Genetics of Respiratory Viruses at the Pasteur Institute in Paris, France.

Van der Werf adds that this affinity will, however, be affected by other genetic changes in the virus, which at present are an unknown factor.

Multiple mutations

ADVERTISEMENT
 

Thankfully, one mutation alone is unlikely to lead to efficient human-to-human transmission. The genetic changes that would allow this to happen are poorly understood, but are thought to require an exact combination of changes in multiple genes.

"Adaptation to humans is a polygenic trait. It requires mutations in each of the eight segments of the virus's genome. Every one has to be correctly optimized to ensure human-to-human transmission," explains Edward Holmes, who is studying virus evolution at Pennsylvania State University in Philadelphia. "You are talking multiple mutations across the entire genome."

That's an improbable, but not impossible event.

Researchers continue to examine the genome of bird flu viruses, and are taking measures to stop the spread of disease among birds and people in Turkey.

A mutated strain of bird flu has genetic make up that increases its chance of transferring to people.




 

von Novartis

http://de.biz.yahoo.com/060119/38/4u7e4.html

Xolair (Omalizumab) ist einer der ersten monoklonalen Antikörper seiner Art zur Behandlung von schwerem persistierendem allergischem Asthma. Das Medikament wurde im Oktober 2005 in der EU zugelassen. Die Einführung von Xolair in den wichtigsten europäischen Ländern ist in Vorbereitung. Das Medikament gilt unter vielen Experten in der Asthma-Behandlung als einer der bedeutendsten Fortschritte der vergangenen 15 Jahre. Xolair wurde erstmals im Juni 2003 in den USA zugelassen, wo es seither schätzungsweise 55 000 Patienten verschrieben wurde. Xolair wurde im Rahmen einer Kooperationsvereinbarung zwischen der Novartis Pharma AG, Genentech und Tanox entwickelt.


Lucentis (Ranibizumab) besitzt das Potenzial, neuer Therapiestandard für "feuchte" altersbedingte Makuladegeneration (AMD) zu werden. Der EU-Zulassungsantrag soll im ersten Quartal 2006 eingereicht werden. Im Rahmen der Phase-III-Studie ANCHOR erreichte Lucentis nach einjähriger Behandlung den primären Wirksamkeitsendpunkt, der die Aufrechterhaltung oder Verbesserung der Sehfähigkeit betraf. Der Zulassungsantrag für Lucentis in den USA wurde im Dezember durch Genentech eingereicht. Genentech behält in den USA die Entwicklungs- und Vermarktungsrechte des Produkts.
 

AVII (vgl. Posting 21/22 /Ende November und 34) hat heute einen Erfolg gegen das H5N1-Virus vermelden können. In 34 schrieb ich noch, dass dieses Anwendungsgebiet bei AVII bislang eine Nebenrolle spielte, da die Hep C weiter fortgeschritten sind.  Das dürfte ab heute anders sein. Die Aktie gewinnt über 30% auf diese Nachricht hin. Seit dem 1. Posting zu dem Unternehmen in diesem Thread immerhin über 100% Kursplus.

http://biz.yahoo.com/bw/060120/20060120005147.html?.v=1

Press Release Source: AVI BioPharma, Inc.


AVI BioPharma Reports Confirmation of Efficacy against Influenza Strains
Friday January 20, 9:00 am ET  
NEUGENE Antisense Efficacy against Influenza Strains, Including Avian Influenza, to Lead to IND Filing with the FDA


PORTLAND, Ore.--(BUSINESS WIRE)--Jan. 20, 2006--AVI BioPharma, Inc. (Nasdaq:AVII - News) today announced confirmation from three independent laboratories of NEUGENE® antisense efficacy in preclinical experiments against multiple strains of influenza, including avian influenza strain H5N1.
Dr. P. Puthavathana at Mahidol University in Bangkok, Thailand, confirmed NEUGENE antisense efficacy against an H5N1 viral isolate in her assay system.
Dr. Darwyn Kobasa at the Public Health Agency of Canada in Winnipeg, Manitoba, completed an initial dose-response study in cell culture demonstrating NEUGENE efficacy against both the H1N1 and H3N2 strains.
Dr. Manoj Pastey at Oregon State University in Corvallis, Ore., confirmed efficacy using the same NEUGENE antisense agents against the H7N7 and H3N8 strains.
Taken together, these data confirm efficacy observed with the H1N1 strain previously reported from Drs. Jianzhu and Chen Qin Ge at Massachusetts Institute of Technology in Boston and now represent positive reports from four laboratories using different endpoints and methodologies.

"These confirmations validate our approach to blocking replication of influenza viruses. We now believe that a single NEUGENE drug could be effective against most influenza subtypes, including the H5N1 avian strain," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "By targeting regions of the viral genetic code that are common to all influenza A subtypes, we expect that our NEUGENE drugs will be effective against avian flu and the far more common influenza A viruses, which kill an average of 35,000 Americans every year."

AVI is also conducting collaborative animal studies evaluating NEUGENE efficacy against influenza strains at Tulane University in New Orleans and at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) in Frederick, Maryland.

"Based on these recent findings and other results from additional studies, AVI now plans to file an Investigative New Drug (IND) application with the FDA for the treatment of influenza A virus with NEUGENE antisense drugs," said Denis R Burger, Ph.D., chief executive officer of AVI. "We feel confident in the safety, efficacy and potency of our NEUGENE drugs targeting influenza and plan to move forward into the clinical trial process later this year."

AVI's NEUGENE antisense drug development program against the influenza A virus specifically targets genetic regions of the virus that are highly conserved between six viral subtypes that cause human disease. These include three subtypes that caused pandemics in the 20th century -- the 1918 Spanish flu (H1N1), the 1957 Asian flu (H2N2) and the 1968 Hong Kong flu (H3N2) -- and three subtypes of avian flu that have been reported to cause disease in humans (H5N1, H7N7 and H9N2).

AVI's Antiviral Program

AVI's proprietary NEUGENE antisense drug candidates have demonstrated efficacy in preclinical studies against SARS coronavirus, West Nile virus (WNV), hepatitis C virus (HCV), dengue virus, Ebola virus, and Marburg virus. AVI has filed IND applications with the U.S. Food and Drug Administration and has ongoing clinical trials in WNV and HCV.

Showing how versatile NEUGENE drugs can be across viral subtypes, AVI demonstrated in its collaboration with the Centers for Disease Control and Prevention that NEUGENE agents are efficacious against all four immunologically distinct subtypes of the dengue virus. This outcome was achieved by targeting a highly conserved region of the dengue viral genetic code. In collaborative work with the USAMRIID targeting the Ebola virus, NEUGENE drugs protected three animal species from lethal challenges with this virus (see PloS Pathog 2(1): e1). Additional clinical development efforts targeting dengue virus and Ebola virus are planned for 2006.

The speed with which effective NEUGENE drugs can be designed and manufactured exceeds any other modern drug development timeframe. For example, NEUGENE compounds targeting SARS, WNV and Ebola were developed within days to weeks of obtaining the appropriate genetic sequences for the viruses.

AVI's Clinical Experience

AVI's NEUGENE antisense drugs have a well-defined safety record in human clinical trials. Approximately 300 patients have been dosed with NEUGENE drug candidates targeting host and viral gene targets in 12 clinical studies under multiple INDs. Five routes of administration have been employed in AVI's clinical studies, and doses up to 450 mg have been administered without a single drug-related, serious adverse event. The combination of AVI's NEUGENE chemistry with conserved viral targets that are not expressed in the human genome makes a strong case for the potential for success in the development of candidates to address influenza, including the possible emergence of a transmittable avian flu.

About Influenza A Viruses

Influenza, or flu, is a contagious respiratory illness caused by influenza viruses. On average 5 percent to 20 percent of the U.S. population is infected with the flu each year. Influenza A virus is an enveloped negative-strand RNA virus, with eight genome segments that code for 10 proteins. Influenza strains are subtyped according to the antigenic and genetic nature of their surface glycoproteins: hemagglutinin (HA or H) and neuraminidase (NA or N). Fifteen H and nine N subtypes have been identified, with three associated with widespread human disease (H1N1, H2N2 and H3N2). In addition, several subtypes of avian influenza virus -- H5N1, H7N7 and H9N2 -- can infect and cause disease in humans.

The current influenza pandemic in birds throughout Asia, Eastern Europe and Turkey is caused by the H5N1 subtype. It is thought that co-infection of humans or certain animals (such as pigs) with both H1N1 and H5N1 can lead to a reassortment or recombination of viral particles, resulting in the emergence of a virus with dangerous public health properties, namely one to which the human population has no natural immunity and which has the ability to spread easily from person to person. It is believed that emergence of avian flu by this general mechanism may have led to the worldwide pandemics of 1918, 1957 and 1968.

About AVI BioPharma

AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, cancer and polycystic kidney disease. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus and Ebola virus. AVI has introduced a NEUGENE-based exon-skipping technology called ESPRIT therapy. More information about AVI is available on the company's Web site at http://www.avibio.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the company's Securities and Exchange Commission filings.



Contact:
AVI BioPharma, Inc.
Michael Hubbard, 503-227-0554
hubbard@avibio.com
or
Lippert/Heilshorn & Associates Inc.
Bruce Voss, 310-691-7100 (Investors)
bvoss@lhai.com
Jody Cain, 310-691-7100 (Investors)
jcain@lhai.com
or
Waggener Edstrom Worldwide
Bioscience and Healthcare Practice
Jenny Moede, 503-443-7000 (Press)
jmoede@waggeneredstrom.com

--------------------------------------------------
Source: AVI BioPharma, Inc.




 

Lange darsuf gewartet, nun ist es soweit:
(zur Diskussion dazu siehe wallstreet online thread von eck)

 http://de.biz.yahoo.com/25012006/36/hugin-news-morphosys-ag.html

dpa-afx
Hugin-News: MorphoSys AG
Mittwoch 25. Januar 2006, 07:31 Uhr


Roche (Virt-X: ROG.VX - Nachrichten) plant Start der klinischen Entwicklung mit einem von MorphoSys (Xetra: 663200 - Nachrichten) generierten Alzheimer-Antikörper
Corporate news- Mitteilung verarbeitet und übermittelt durch Hugin. Für den Inhalt der Mitteilung ist der Emittent verantwortlich.

--------------------------------------------------

--------------

Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment; TecDAX) Anzeige
 
gab heute bekannt, dass ihr Partner Roche alle notwendigen Anträge für den Start einer europäischen Phase-1-Studie mit einem HuCAL®-basierten Antikörper zur Behandlung von Alzheimer eingereicht hat. Der HuCAL® Antikörper soll anormale, für Alzheimer-Patienten typische Ansammlungen des Proteins Amyloid-beta im Gehirngewebe, so genannte Plaques, angreifen und diese auflösen helfen. Der Antrag für den Beginn klinischer Studien löst eine Meilensteinzahlung von Roche an MorphoSys aus. Weitere finanzielle Einzelheiten wurden nicht bekannt gegeben. In präklinischen Studien hat der vollständig menschliche Antikörper eine hoch-affine Bindung an die Amyloid-beta-Plaques gezeigt und konnte diese spezifisch in menschlichen Gewebeproben von Alzheimer-Patienten erkennen. Darüber hinaus konnte in einem in-vitro-Test durch Bindung des Antikörpers an Amyloid-beta-Moleküle eine Ansammlung der Proteine aufgelöst werden. Der HuCAL® Antikörper wurde darüber hinaus in einem Tiermodell für die Untersuchung von Alzheimer eingesetzt. In die Blutbahn verabreicht konnte der Antikörper hier zeigen, dass er die Blut-Hirn-Schranke passieren und an Amyloid-beta-Plaques im Gehirn binden kann. Die internationale Alzheimer-Forschung sieht im Aufbrechen der Amyloid-beta-Ansammlungen einen viel versprechenden Ansatzpunkt für eine Therapie der Krankheit. Ein Entfernen der Plaques konnte mit einer Verbesserung der kognitiven Funktionen in Verbindung gebracht werden. "Wir sind sehr stolz, einen vollständig menschlichen Antikörper aus der HuCAL® Technologie von MorphoSys in die klinische Entwicklung bringen zu können. Dies ist ein wichtiger Schritt hin zu einer modernen Therapie von Alzheimer mit einer neuen Substanzklasse", sagte Andrew Sleight, Leiter der Forschungsabteilung Zentralnervensystem (ZNS) bei Roche. "Alzheimer ist sowohl eine verheerende Krankheit für die Betroffenen, als auch eine enorme finanzielle Belastung für die Gesundheitssysteme weltweit", erklärt Dr. Marlies Sproll, Forschungsvorstand der MorphoSys AG. "Der Antikörper aus unserer Kooperation mit Roche hat sich als sehr aussichtsreicher Kandidat in präklinischen Studien erwiesen und wir erwarten den Ausgang der Studien in menschlichen Patienten mit großem Interesse."

http://hugin.info/130295/R/1031187/165553.pdf

MorphoSys in Kürze: MorphoSys beschäftigt sich mit der Entwicklung und Anwendung von Technologien zur Herstellung synthetischer Antikörper, die die Entdeckung neuer Medikamente bzw. krankheitsassoziierter Zielmoleküle beschleunigen. Das Unternehmen wurde 1992 gegründet und verfügt über eine Reihe innovativer Technologien, allen voran HuCAL®, die Humane Kombinatorische Antikörper-Bibliothek, die weltweit von Wissenschaftlern zur Herstellung von menschlichen Antikörpern genutzt wird. Das Unternehmen hat Partnerschaften mit internationalen pharmazeutischen Unternehmen wie Bayer (Berkeley, Kalifornien/USA), Boehringer Ingelheim (Ingelheim, Deutschland), Bristol-Myers Squibb (Wilmington (London: WIL.L - Nachrichten) , Delaware/USA), Centocor Inc. (Malvern, Pennsylvania/USA), GPC Biotech AG (Xetra: 585150 - Nachrichten) (Martinsried/Deutschland), Hoffmann-La Roche AG (Basel/Schweiz), ImmunoGen Inc (NASDAQ: IMGN - Nachrichten) . (Cambridge, Massachusetts/USA), Novartis AG (Basel, Schweiz), Merck & Co., Inc. (New Jersey/USA), Novoplant GmbH (Gatersleben, Deutschland), Pfizer Inc. (Delaware/USA), ProChon Biotech Ltd. (Rehovot/Israel), Schering AG (Xetra: 717200 - Nachrichten) (Berlin/Deutschland), Shionogi & Co (München: 855648 - Nachrichten) ., Ltd. (Osaka/Japan), Xoma Ltd (NASDAQ: XOMA - Nachrichten) . (Berkeley, Kalifornien/USA) und andere. MorphoSys ist im Markt der Forschungsantikörper durch seine Geschäftseinheit Antibodies by Design tätig. Antibodies by Design wurde im Jahr 2003 gegründet, um den nicht-therapeutischen Markt für MorphoSys zu erschließen. Die Aktivitäten in diesem Bereich wurden durch die Akquisition der Biogenesis-Gruppe in Großbritannien und in den USA im Januar 2005 sowie durch die Akquisition der Serotec-Gruppe in 2006 nachhaltig gestärkt. Weitere Informationen finden Sie unter http://www.morphosys.com/. Für weitere Informationen kontaktieren Sie bitte: Dr. Claudia Gutjahr-Löser, Director Corporate Communications, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com oder Mario Brkulj, Manager Public Relations, Tel: +49 (0) 89 / 899 27-454, brkulj@morphosys.com --- Ende der Mitteilung --- WKN: 663200; ISIN: DE0006632003; Index: CDAX, HDAX, Prime All Share, TECH All Share, TecDAX (Xetra: Nachrichten) , MIDCAP; Notiert: Prime Standard in Frankfurter Wertpapierbörse, Geregelter Markt in Frankfurter Wertpapierbörse, Freiverkehr in Börse Berlin Bremen, Freiverkehr in Börse Düsseldorf, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr in Niedersächsische Börse zu Hannover, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Stuttgart;

http://www.morphosys.com

Copyright © Hugin ASA 2006. All rights reserved.

 

http://biz.yahoo.com/ap/060125/...ntibody_technology_humira.html?.v=1

AP
Cambridge Antibody Drug Now Blockbuster
Wednesday January 25, 12:42 pm ET  
Cambridge Antibody Technology Group Says Arthritis Drug It Developed Achieves Blockbuster Status


NEW YORK (AP) -- Cambridge Antibody Technology Group PLC acknowledged Wednesday that the arthritis drug it developed has finally achieved blockbuster status in excess of previous estimates.
The Cambridge, England-based biotech company noted that Abbott Laboratories reported worldwide Humira sales of $1.4 billion, above the estimated $1.3 billion in sales. A blockbuster drug is one that has annual sales in excess of $1 billion. Humira is Cambridge's first marketed product. The company receives royalties of about 2.7 percent of Abbott's worldwide Humira sales. Abbott reported today that its 2005 revenue rose 14 percent to $22.34 billion from a year ago.

ADVERTISEMENT


Cambridge Antibody also recognized that Abbott forecasts worldwide Humira sales of $1.9 billion in 2006.

The two companies reached a settlement in October over Humira royalty rates. Abbott agreed to pay Cambridge more than $300 million, but reduced the royalty rate to the present one from 5.1 percent.

Cambridge American depositary shares rose 37 cents, or 3.2 percent, to $11.98 in midday trading on the Nasdaq. Abbott shares added $2.58, or 6.4 percent, to $42.64 on the New York Stock Exchange.



 

Anmerkung von mir: Es wird in der Pressemeldung nicht erwähnt, aber der
AK 1D09C3 wurde von Morphosys mit HuCAL für GPC hergestellt.

http://www.ariva.de/news/article.m?id=2008448&secu=719

GPC Biotech: 1D09C3 erhält Orphan-Drug-Status von EU-Kommission  

10:53 27.01.06  

Das biopharmazeutische Unternehmen GPC Biotech AG (ISIN DE0005851505/ WKN 585150) gab am Freitag bekannt, dass die Europäische Kommission dem monoklonalen Krebsantikörper 1D09C3 den so genannten Orphan-Drug-Status für die Anwendung bei chronischer lymphatischer Leukämie erteilt hat.

Der Orphan-Drug-Status der EMEA soll die Entwicklung solcher Medikamente fördern, die seltene lebensbedrohende oder äußerst ernste Leiden behandeln und die nicht mehr als fünf von 10.000 Personen in der EU betreffen. In der EU genießen Orphan Drugs in der ausgewiesenen Indikation Marktexklusivität von bis zu zehn Jahren. Andere mögliche Vorteile sind unter anderem: Gebührenminderungen im Zusammenhang mit verschiedenen Vorgängen des Zulassungsverfahrens, wie etwa beim Antrag auf Marktzulassung, sowie Unterstützung bei der Erstellung von Prüfplänen für die zulassungsrelevanten Studien.

1D09C3 ist ein Anti-MHC (Major Histocompatibility Complex) Klasse II monoklonaler Antikörper. Er bindet an spezifische Zelloberflächenrezeptoren und führt so zum gezielten Absterben aktivierter, sich vermehrender MHC-Klasse-II-positiver Tumorzellen, darunter B-Zell- und T-Zell-Lymphome sowie weitere Blutkrebsarten. In präklinischen Studien konnte gezeigt werden, dass 1D09C3 den programmierten Zelltod auslöst, ohne hierfür ein voll funktionsfähiges Immunsystem zu benötigen.

Der Krebsantikörper befindet sich derzeit in einem klinischen Phase-1-Studienprogramm, in welchem er bei Patienten getestet wird, die an einem resistenten B-Zell-Lymphom leiden oder nach einer zuvor durchgeführten Standardtherapie einen Rückfall erlitten haben. 1D09C3 wurde bereits für die Behandlung von Hodgkin-Lymphom der Orphan-Drug-Status zugesprochen.

Bisher stiegen die Aktien um 4,11 Prozent und schlossen bei 11,66 Euro.


 

 
Link

February 3rd, 2006

New Study Supports Ep-CAM as Prime Target for Antibody Therapy in Common Cancers



Ep-CAM Is Frequently Expressed in Colon, Lung, Prostate and Gastric Cancers

February 3, 2006 ? Munich, Germany ? The University of Basel, Switzerland, and Micromet AG have published a new study on the frequent high-level expression of antibody target epithelial cell adhesion molecule (Ep-CAM) in colon, lung, prostate and gastric cancers. The report has been published in the British Journal of Cancer (2006, 94: 128 ? 135) (1). Ep-CAM is the target for Micromet's human antibody adecatumumab (MT201), which currently is in two phase II clinical trials in prostate and metastatic breast cancer, and is partnered with Serono.

The immunohistochemical study analyzed Ep-CAM expression on tissue micro-array samples from more than 4,000 cancer patients. Patient samples were derived from primary tumor tissues covering all stages, grades and histologies of respective cancer indications. High-level Ep-CAM expression, i.e. an intense and homogenous staining of tumor cells was observed for 97.7% of colon, 63.9% of lung, 87.2% of prostate and 90.7% of gastric cancer patients.

"Through its scientific co-founder Gert Riethmuller of Munich University, Micromet has a long-standing expertise and interest in Ep-CAM as a target for antibody-based therapeutics. Our data strongly support the notion that Ep-CAM is a prime target for immunotherapy", comments Patrick Baeuerle, Micromet's Chief Scientific Officer. "Together with data published earlier on breast cancer, our study suggests that a large percentage of patients with colon, lung, prostate, gastric and breast cancer may qualify for treatment with Ep-CAM-directed antibody therapies, such as adecatumumab. Therefore, we expect that at least five of the most frequent human malignancies can potentially be addressed by our product candidate."

Recently published studies support that over expression of Ep-CAM plays a pivotal role in tumorigenesis. In human breast cancer, over expression of Ep-CAM is a negative and independent prognostic marker for overall survival (2), and Ep-CAM is expressed significantly higher on metastatic than on primary breast tumors (3). Proliferation, migration and invasiveness of tumor cells is inhibited when Ep-CAM expression in breast cancer cell lines is reduced by a specific small inhibitory RNA (4). When over expressed in quiescent cells, Ep-CAM behaves like a classical oncogene, enabling growth of cells in soft agar and independence on serum growth factors (5). Lastly, highly tumorigenic human breast cancer stem cells are characterized by expression of Ep-CAM (ESA) (6).

In January 2006, Micromet announced a definitive agreement to merge with CancerVax Corporation (NASDAQ: CNVX) to create a transatlantic, NASDAQ-listed company with a highly differentiated drug development pipeline focused on oncology, autoimmune and inflammatory diseases, and a proprietary technology base for the development of antibody-based product candidates. The merger is subject to a number of conditions and expected to close in the second quarter of 2006. Upon closing of the transaction, the Company's shares are expected to continue to trade on the NASDAQ National Market.  CancerVax will be renamed as Micromet, Inc., and application will be made to NASDAQ to change the ticker symbol to "MITI". CancerVax expects to file a Form S-4 and related proxy statement/prospectus with the U.S. Securities and Exchange Commission and any other necessary government filings in the coming weeks. ###

Contact
Media: Evelyn Wolf
Phone: +49 89 895277-220, Email: evelyn.wolf@micromet.de

Investors: Ines-Regina Buth
Phone: +49 89 895277-221, Email: ines-regina.buth@micromet.de

References
(1) Went P, Vasei M, Bubendorf L, Terracciano L, Tornillo L, Riede U, Kononen J, Simon R, Sauter G, Baeuerle PA (2006). Frequent high-level expression of the immunotherapeutic target Ep-CAM in colon, stomach, prostate and lung cancers, Brit J Cancer 94: 128-35.

(2) Spizzo G, Went P, Dirnhofer S, Obrist P, Simon R, Spichtin H, Maurer R, Metzger U, von Castelberg B, Bart R, Stopatschinskaya S, Kochli OR, Haas P, Mross F, Zuber M, Dietrich H, Bischoff S, Mirlacher M, Sauter G, Gastl G (2004). High Ep-CAM expression is associated with poor prognosis in node-positive breast cancer. Breast Cancer Res Treat  86: 207-13.

(3) Rao CG, Chianese D, Doyle GV, Miller MC, Russell T, Sanders Jr RA, Terstappen LWMM (2005). Expression of epithelial cell adhesion molecule in carcinoma cells in blood and primary and metastatic tumors. Intl J Oncol  27: 49-57.

(4) Osta WA, Chen Y, Mikhitarian K, Mitas M, Salem M, Hannun YA, Cole DJ, Gillanders WE (2004). Ep-CAM is overexpressed in breast cancer and is a potential target for breast cancer gene therapy. Cancer Res 64: 5818-24.

(5) Munz M, Kieu C, Mack B, Schmitt B, Zeidler R, Gires O (2004). The carcinoma-associated antigen Ep-CAM upregulates c-myc and induces cell proliferation. Oncogene 23: 5748-58.

(6) Al-Hajj W, Micha M, Benito-Hernandez A, Morrison SJ, Clarke MF (2003). Prospective identification of tumorigenic breast cancer cells. Proc Natl Acad Sci USA 100: 3983-8.

About Micromet
Micromet AG is a private Munich, Germany-based biotechnology company with a focus on the development of novel, proprietary antibody-based products for cancer and inflammatory and autoimmune diseases. Two product candidates are currently in clinical trials. MT201, a recombinant human monoclonal antibody is being evaluated in Phase 2 clinical trials for the treatment of certain solid tumors.  MT103 is being studied in a Phase 1 clinical trial. The Company has established a powerful drug development platform based on its BiTE? technology, a unique drug format that leverages the cytotoxic potential of T cells, the most powerful 'killer cells' of the human immune system. Micromet has integrated infrastructure and expertise in all disciplines of drug design and development. The Company has attracted both top-tier life science investors and collaborators, such as MedImmune, Inc. and Serono.  

In January 2006, Micromet announced an agreement to merge with CancerVax Corporation (NASDAQ: CNVX) to create a transatlantic, NASDAQ-listed company with a highly differentiated drug development pipeline focused on oncology, autoimmune and inflammatory diseases, and a proprietary technology base for the development of antibody-based product candidates. The merger is subject to a number of conditions and expected to close in the second quarter of 2006.
For further information, please visit the Company's website at www.micromet.de.

 

Der schweizerischen Cytos AG sind klinische Wirksamkeitsnachweise für Impfstoffe zur Behandlung von Allergien und Nikotinsucht gelungen. 4 neue klinische Studien u.A. zu Hausstaubmilbenallergien , teilweise mit Novartis wurden begonnen.  

Habe jetzt eine zeitlang hier nichts gespostet.
Daher eine kurze Anmerkung zuvor: Zu dem schlimmen Vorfall beim Phase 1 Test des TeGeneroAk in London, der die Öffentlichkeit stark beschäftigte (Presseartikel  und Fernsehberichte) hat ecki bei Wallstreet Online (eck64) einen eigenen Dokumentationsthread eröffnet. Daher poste ich hier nichts dazu obwohl natürlich misserfolge ebenso wie Erfolge zu einem AK Thread gehören und verweise auf den genannten Thread.

TeGenero Parexel Vorfall


--------------
Nun zu Panitumumab

Phase III

Business Wire
Randomisierte Phase-3-Studie zeigt, dass Panitumumab zur erheblichen Verlängerung des progressfreien Überlebens und zur Krankheitskontrolle bei Patien  
Dienstag 4. April 2006, 20:44 Uhr

Aktienkurse  
Amgen
AMGN
72.01
+0.18%








THOUSAND OAKS, Kalif. 3. April 2006 Amgen (Nasdaq:AMGN), das größte Biotechnologie-Unternehemen weltweit, gab heute Ergebnisse der Phase-3-Pivotalstudie bekannt, die zeigen, dass Panitumumab das progressfreie Überleben der Krankheit und die Krankheitskontrolle (Ansprechrate und Stillstand der Krankheit) wesentlich verbessert verglichen mit Patienten, die mit besten verfügbaren Therapien (Best Supportive Care, BSC) bei fortgeschrittenem Kolorektalkrebs behandelt wurden und bei denen die konventionelle Chemotherapie nicht angeschlagen hatte. Die Ergebnisse wurden bei einer klinischen Plenarsitzung bei der 97. Jahresversammlung der ANZEIGE

American Association for Cancer Research (Abstract #CP-1) präsentiert.
"Panitumumab reduzierte das Fortschreiten der Krankheit um etwa die Hälfte verglichen mit den mit den besten verfügbaren Therapien behandelten Patienten", sagte Marc Peeters, M.D., Ph.D., Koordinator der Digestive Oncology Unit im Universitätsklinikum Gent und einer der Versuchsleiter der Studie. "Darüber hinaus ergaben die Unterschiede bei der objektiven Ansprechrate und dem Verhältnis der Patienten mit einer Stabilisierung der Krankheit zwischen Panitumumab und der besten verfügbaren Therapie die signifikante Wirksamkeit dieses Wirkstoffs."

Bei dieser multinationalen, offenen Phase-3-Studie wurden 463 Patienten mit fortgeschrittenem Kolorektalkrebs, bei denen die konventionelle Chemotherapie einschließlich Oxaliplatin und Irinotecan nicht angeschlagen hatte, randomisiert und erhielten 6 mg/kg Panitumumab plus BSC (n=231) alle zwei Wochen oder nur BSC (n=232). Ein unabhängiger zentraler Radiologie-Prüfungsausschuss beurteilte den Krankheitsverlauf und das Schrumpfen der Tumoren.

Patienten, die alle zwei Wochen Panitumumab erhielten, wiesen eine 46%ige Verringerung des Tumorfortschritts gegenüber denen auf, die nur BSC erhielten (p weniger als 0.000 000 001). Eine verhältnismäßig höhere Anzahl von Patienten zeigte mit Panitumumab an allen planmäßigen Untersuchungszeitpunkten bis Woche 32 kein weiteres Fortschreiten der Krankheit bzw. überlebten bis Woche 32. Zum Beispiel lebten nach sechs Monaten (Woche 24) ungefähr viermal mehr Patienten, die mit Panitumumab behandelt wurden, ohne weiteres Fortschreiten der Krankheit (18 Prozent gegenüber fünf Prozent, die nur BSC erhielten).

Doppelt so viele Patienten, die mit Panitumumab behandelt wurden, lebten in der Woche 32 ohne weiteres Fortschreiten der Krankheit (10 Prozent gegenüber vier Prozent, die nur BSC erhielten).

Versuchsleiter berichteten auch, dass Panitumumab gegenüber BSC allein die Krankheitskontrolle wesentlich verbesserte (36 Prozent gegenüber 10 Prozent), wie anhand der Ansprechrate und des Stillstandes der Krankheit bemessen wurde. Die objektiv und unabhängig bewertete Ansprechrate betrug mit Panitumumab acht Prozent gegenüber null mit BSC allein und die durchschnittliche Dauer der Response betrug 17 Wochen. Die Rate bezüglich des Stillstandes der Krankheit betrug mit Panitumumab 28 Prozent gegenüber 10 Prozent mit BSC allein.

Rund 75 Prozent der Patienten, die mit den besten verfügbaren Therapien behandelt wurden, wurden in einen Cross-Over-Arm aufgenommen, wo sie Panitumumab nach Fortschreiten ihrer Krankheit erhielten (n = 174). Die Behandlung mit Panitumumab erwies sich auch bei Patienten, die von dem BSC-Arm wechselten, als klinisch vorteilhaft, trotz des Progresses der Krankheit. In diesen Patienten bewirkte die Behandlung mit Panitumumab eine partielle Response von 10% und eine Stabilisierung der Krankheit und komplette Response bei 32 Prozent.

Eine Zwischenanalyse des Gesamtüberlebens in den beiden Gruppen erbrachte ähnliche Ergebnisse. Die Rate (75 Prozent) und der Zeitpunkt (durchschnittlich nach 7 Wochen) des Crossover aus dem Arm, der nur BSC erhielt, zu einer Behandlung mit Panitumumab sowie die Antitumoraktivität, die nach dem Crossover festgestellt wurde, beeinträchtigte die Möglichkeit, einen Behandlungseffekt auf das Gesamtüberleben zu zeigen (Risikoverhältnis = 0,93).

Panitumumab verbesserte das progressfreie Überleben und die Responserate unabhängig von dem gemessenen Grad bzw. der Intensität der EGFr-Färbung. Die Verbesserungen des progressfreien Überlebens und der Krankheitskontrolle waren unabhängig vom Alter, Geschlecht, dem Ort des primären Tumors (Kolon oder Rektum) oder dem Performance-Status.

Prüfplangemäß erforderte die Gabe von Panitumumab keine Vormedikation oder Aufsättigungsdosis und die Inzidenz von Infusionsreaktionen (jeden Schweregrades) war niedrig (ein Prozent). Es gab keine Infusionsreaktionen 3. oder 4. Grades. Im Panitumumab-Arm gaben mehr Patienten toxische Hautreaktionen, Erschöpfung, Bauchschmerzen, Übelkeit und Durchfall an. Bei 38 Prozent der mit Panitumumab behandelten Patienten wurde eine Hypomagnesiämie beobachtet (drei Prozent 3./4. Grades). Es bildeten sich weder Human-Anti-Human-Antikörpern (HAHA) noch Antikörper gegen Panitumumab de novo. Bei Patienten mit Anti-Panitumumab -Antikörpern wurde kein Einfluss auf die Wirksamkeit, Sicherheit und Pharmakokinetik festgestellt.

Patienten und Ärzte erhalten unter www.amgentrials.com mehr Informationen über laufende klinische Studien mit Panitumumab.

Webcast-Information

Amgen veranstaltet heute um 12.30 EDT ein Webcast mit der Investmentgemeinschaft, um die Daten der Phase-3-Studie zu erörtern. Das Webcast ist offen für Mitglieder der Nachrichtenmedien, Investoren und die allgemeine Öffentlichkeit über die Website von Amgen unter www.amgen.com unter der Rubrik "Investoren". Das Webcast wird außerdem archiviert und steht mindestens 72 Stunden lang nach Ende der Veranstaltung für eine Wiederholungsabspielung zur Verfügung.

Über Panitumumab

Bei Panitumumab handelt es sich um einen experimentellen vollständig humanen monoklonalen Antikörper, der gegen den Rezeptor des epidermalen Wachstumsfaktor (EGFr) gerichtet ist, ein Protein, das bei der Signalübertragung von Krebszellen eine wichtige Rolle spielt. Panitumumab, ein monoklonaler IgG2-Antikörper, bindet mit hoher Affinität an EGFr. Panitumumab wurde anhand der XenoMouse®-Technologie hergestellt, welche einen vollständig humanen monoklonalen Antikörper erzeugt, der kein Mausprotein enthält. Das Immunsystem des Körpers kann das in chimären und humanisierten Antikörpern vorhandene Mausprotein als fremd erkennen und eine Immunantwort in Form von Infusionsreaktionen, allergischen Reaktionen oder Anaphylaxien auslösen. Das Ziel der Entwicklung vollständig humaner monoklonaler Antikörper ist es, eine wirksame und hoch affine Therapie anzubieten, die das Risiko dieser Art von Immunantwort minimiert.

Panitumumab erhielt im Juli 2003 von der US-amerikanischen Food and Drug Administration (FDA) die Einstufung "Fast Track" als Indikation bei Patienten mit metastasierendem Kolorektalkarzinom, die auf Standardchemotherapien nicht ansprechen. In klinischen Studien wurde der Wirkstoff sowohl als Monotherapie als auch in Kombination mit anderen Wirkstoffen zur Behandlung verschiedener Krebsarten, beispielsweise Kolorektalkrebs, Lungenkrebs und Krebs im Kopf-/Halsbereich, untersucht.

Über den Rezeptor des epidermalen Wachstumsfaktors (EGFr)

EGFr ist normalerweise an der Regulierung des Wachstums vieler verschiedener Zellen im Körper beteiligt, kann aber auch das Wachstum von Krebszellen anregen. Tatsächlich brauchen viele Krebszellen Signale vom EGFr um zu überleben. Der Rezeptor sitzt auf der Oberfläche dieser Tumorzellen und wird aktiviert, wenn natürlicherweise im Körper vorkommende Proteine, beispielsweise der epidermale Wachstumsfaktor (EGF) oder der transformierende Wachstumsfaktor alpha (TGF-alpha), an ihn binden. Durch diese Bindung verändert sich die Form des EGFr, wodurch wiederum interne zelluläre Signale in Gang gesetzt werden, die das Wachstum der Tumorzelle anregen. Panitumumab bindet an den EGFr, wodurch die Bindung natürlicher Liganden wie EGF und TGF-alpha an den Rezeptor verhindert wird und die Signale, die andernfalls das Wachstum der Krebszelle stimulieren und ihr Überleben ermöglichen würden, blockiert werden.

Über Kolorektalkarzinom

Kolorektalkrebs ist die dritthäufigste Krebsart, die in den USA bei Männern und Frauen diagnostiziert wird. Die American Cancer Society schätzt, dass 2006 rund 106.680 neue Fälle von Kolonkrebs und 41.930 neue Fälle von Rektalkrebs diagnostiziert werden.

Über Amgen

Amgen entdeckt, entwickelt und liefert innovative humane Medikamente. Amgen ist seit 1980 ein Pionier in der Biotechnologie und war eines der ersten Unternehmen, welches das neue Versprechen der Wissenschaft, sichere und wirksame Medikamente aus dem Labor zur Produktionsanlage zum Patienten zu bringen, umsetzte. Die Medikamente von Amgen haben die Anwendung von Medizin verändert und halfen Millionen von Menschen in der ganzen Welt bei dem Kampf gegen Krebs, Nierenerkrankungen, rheumatoide Arthritis und andere ernste Erkrankungen.

Mit einer langen Reihe potenzieller neuer Medikamente verpflichtet sich Amgen weiterhin, die Wissenschaft so voranzutreiben, dass die Lebensqualität der Menschen erheblich verbessert wird. Um mehr über unsere bahnbrechende Wissenschaft und unsere lebenswichtigen Medikamente zu erfahren, besuchen Sie bitte unsere Webseite unter www.amgen.com.

Amgen zukunftsbezogene Aussagen

Diese neue Pressemitteilung enthält zukunftsbezogene Aussagen, die signifikante Risiken und Unsicherheiten, einschließlich der nachfolgend erklärten und anderen, betreffen, die in unserem Formular 10-K für das am 31. Dezember 2005 beendete Jahr und in unseren regelmäßigen Berichten im Formular 10-Q und Formular 8-K eingesehen werden können. Amgen stellt diese Informationen zum Zeitpunkt dieser neuen Mitteilung bereit und verpflichtet sich nicht, zukunftsbezogene Aussagen, die in diesem Dokument enthalten sind, aufgrund neuer Informationen, künftiger Ereignisse oder sonstigem, zu aktualisieren.

Zukunftsbezogene Aussagen erfolgen ohne Gewähr und aktuelle Ergebnisse können sich wesentlich von den uns vorhergesehenen unterscheiden. Die Entdeckung oder Erkennung neuer Bewerberprodukte oder die Entwicklung neuer Indikationen für bestehende Produkte können nicht garantiert werden und der Weg von der Planung bis zum Produkt ist unsicher; folglich kann nicht garantiert werden, dass ein spezielles Bewerberprodukt oder die Entwicklung einer neuen Indikation für ein bestehendes Produkt erfolgreich sein wird und es ein Handelsprodukt wird. Darüber hinaus garantieren vorklinische Ergebnisse nicht die Sicherheit und Wirksamkeit von Produktkandidaten beim Menschen. Die Komplexität des menschlichen Körpers lässt sich nicht perfekt, und bisweilen nicht einmal annähernd, im Computer oder Zellkultursystemen oder Tiermodellen simulieren. Die Zeit, die Amgen zur Vollendung klinischer Versuche und zur Erlangung behördlicher Genehmigung für den Vertrieb des Produktes benötigt, war in der Vergangenheit unterschiedlich lang und Amgen rechnet auch künftig mit ähnlichen Unterschieden. Amgen entwickelt Produktkandidaten intern und durch Lizenznahmevereinbarungen, Partnerschaften und Joint Ventures. Produktkandidaten, die im Rahmen solcher Geschäftsbeziehungen entstehen, sind ggf. Gegenstand von Auseinandersetzungen zwischen den Parteien oder können sich als nicht so wirksam oder so sicher erweisen, wie Amgen zum Zeitpunkt der Aufnahme solcher Geschäftsbeziehungen angenommen hat. Amgen oder andere könnten Nebenwirkungen oder Produktionsprobleme bei Amgens Produkten feststellen, nachdem sie auf dem Markt sind.

Zudem werden die Umsätze von Amgens Produkten beeinflusst durch Rückerstattungsverträge, die durch Versicherungen Dritter erhoben werden, einschließlich Regierungen, private Krankenkassen und Pflegedienstleister und können auch beeinflusst werden durch inländische und internationale Trends in Bezug auf Pflege- und Gesundheitskostendämpfung als auch durch eventuelle US-amerikanische Gesetze, welche Einfluss haben auf die Preisgestaltung in der Pharmazie und auf Rückerstattungen. Regierungsgesetze und Rückerstattungsverträge können die Entwicklung, die Anwendung und die Preisgestaltung unserer Produkte beeinflussen. Außerdem steht Amgen hinsichtlich einiger von Amgen vertriebener Produkte und auch der Entdeckung und Entwicklung neuer Produkte im Wettbewerb mit anderen Unternehmen. Amgen ist der Meinung, dass einige der neueren Produkte, Produktkandidaten oder neuen Indikationen für bestehende Produkte bei und im Falle einer Zulassung und Vermarktung einer Wettbewerbssituation ausgesetzt sein werden. Produkte von Amgen stehen unter Umständen mit Produkten im Wettbewerb, die billiger sind, für die bereits Rückerstattungsverträge vorliegen, die überlegene Leistung haben, einfacher zu verabreichen sind oder in anderer Weise mit unseren Produkten konkurrieren.

Während wir routinemäßig Patente für unsere Produkte und Technologie erlangen, kann zudem der Schutz, den unsere Patente und Patentbewerbungen bieten, von unseren Mitbewerbern angefochten, für ungültig erklärt oder umgangen werden, und es kann nicht garantiert werden, dass Amgen in der Lage sein wird, Patentschutz für Produkte oder Produktkandidaten von Amgen zu erhalten oder aufrecht zu erhalten. Amgen kann ferner nicht garantieren, dass es in der Lage sein wird, kommerziell erfolgreiche Produkte zu produzieren oder den wirtschaftlichen Erfolg der bestehenden Produkte von Amgen aufrecht zu erhalten. Der Kurs der Aktie von Amgen kann von tatsächlichen oder prognostizierten Marktchancen, der Wettbewerbsposition und dem Erfolg bzw. Misserfolg von Produkten oder Produktkandidaten von Amgen beeinflusst werden. Darüber hinaus könnte die Entdeckung signifikanter Probleme in Verbindung mit einem Produkt, das einem Produkt von Amgen ähnlich ist, Auswirkungen auf eine ganze Produktklasse haben und deshalb den Verkauf der betroffenen Produkte und das Geschäft Amgens und das Betriebsergebnis in erheblichem Maße ungünstig beeinflussen.

Die in dieser Pressemeldung beschriebenen wissenschaftlichen Informationen in Bezug auf unsere Produktkandidaten sind vorläufig und experimenteller Natur. Solche Produktkandidaten sind von der US-amerikanischen Food and Drug Administration (FDA) nicht zugelassen und es können und sollten keine Schlussfolgerungen über die Sicherheit oder Wirksamkeit der Produktkandidaten gezogen werden. Nur die FDA kann festlegen, ob die Produktkandidaten in Bezug auf den untersuchten Verwendungszweck sicher und effektiv sind. Darüber hinaus sind die wissenschaftlichen Daten in dieser Pressemeldung, die sich auf neue Indikationen für unsere Produkte beziehen, vorläufig und experimenteller Natur und gehören nicht zu der Kennzeichnung, die von der FDA für diese Produkte gestattet wurde. Die Produkte sind für den experimentellen Gebrauch, der hierin beschrieben ist, nicht zugelassen, und es können und sollten keine Schlussfolgerungen über die Sicherheit oder Wirksamkeit der Produktkandidaten für diesen Gebrauch gezogen werden. Nur die FDA kann festlegen, ob die Produkte in Bezug auf den untersuchten Verwendungszweck sicher und effektiv sind. Medizinisches Fachpersonal sollte sich auf die von der FDA genehmigte Kennzeichnung der Produkte beziehen und verlassen und nicht auf die in dieser Pressemeldung beschriebenen Informationen.

ANMERKUNG DER REDAKTION: Zugang zu einer elektronischen Version dieser Pressemitteilung erhalten Sie auf der Webseite unter www.amgen.com. Um alle Pressemitteilungen zum Zeitpunkt der Herausgabe elektronisch zu erhalten, können sich Journalisten und Medienbeauftragte anmelden, indem sie ein kurzes Formular unter der Medienrubrik der Webseite ausfüllen.

Kontakt

Amgen, Thousand Oaks
Trish Hawkins/Kristen Davis, +1 805-447-4587 (Medien)
Arvind Sood, +1 805-447-1060 (Investoren)


 

Antikörper aus der Brauerei ist natürlich nicht ganz ernst gemeint, es handelt sich um eine Koop zwischen Kirins Pharmatochter und Intercell. Schöner Upfront von 4 Mio.

http://de.biz.yahoo.com/06042006/341/...rin-tochter-antikoerpern.html

Dow Jones
Intercell kooperiert mit Kirin-Tochter bei Antikörpern
Donnerstag 6. April 2006, 08:19 Uhr




WIEN (Dow Jones)--Die Intercell AG, Wien, hat mit der Pharma-Tochter der Kirin Brewery Co Ltd, Tokio, eine Kooperation vereinbart. Die Unternehmen wollen bei der Entwicklung monoklonaler Antikörper gegen schwere Infektionen, die durch Pneumokokken hervorgerufen werden, zusammenarbeiten, wie es in einer Mitteilung vom Donnerstag hieß. Die medizinische Bedeutung von Pneumokokkenerkrankungen, insbesondere bei älteren Menschen, werde immer größer.

Im Zuge der Vereinbarung erhalte Kirin die weltweiten Rechte zur Entwicklung und Vermarktung von Antikörpern, die gegen Antigene gerichtet seien, welche mit Intercells eigenem Antigen-Identifikations-Programm ANZEIGE
 
(AIP) entdeckt worden seien. Diese Technologie identifiziert Antigene, die in Impfstoffen schützend wirken, aber auch passende Ziele sind, um die Ansteckungsfähigkeit von Pathogenen zu blockieren.

Die Partner werden in der prä-klinischen Entwicklung des Produkts zusammenarbeiten; Kirin ist für die klinische Entwicklung, Registrierung und Vermarktung des Produkts verantwortlich, wie Intercell erklärte. Während der Vertragsdauer habe Intercell Anspruch auf Meilenstein-Zahlungen von insgesamt 40 Mio EUR, inklusive einer Vorauszahlung von 4 Mio EUR. Zudem erhalte das Unternehmen Lizenzgebühren aus zukünftigen Produktverkäufen. Zusätzlich würden Intercell alle Entwicklungsaufwendungen erstattet.

DJG/nas/jhe

 

http://www.nytimes.com/2006/04/08/world/europe/...l?pagewanted=1&_r=2

British Rethinking Rules After Ill-Fated Drug Trial
Sign In to E-Mail This Print Single Page Save  By ELISABETH ROSENTHAL,
International Herald Tribune
Published: April 8, 2006
In February, when Rob O. saw the text message from Parexel International pop up on his cellphone in London ? "healthy males needed for a drug trial" for £2,000, about $3,500 ? it seemed like a harmless opportunity to make some much-needed cash. Parexel, based in Waltham, Mass., contracts with drug makers to test new medicines.

Just weeks later, the previously healthy 31-year-old was in intensive care at London's Northwick Park Hospital ? wires running directly into his heart and arteries, on dialysis, his immune system, liver, kidneys and lungs all failing ? the victim of a drug trial gone disastrously bad.

One of six healthy young men to receive TGN1412, a novel type of immune stimulant that had never before been tried in humans, Rob O. took part in a study that is sending shock waves through the research world and causing regulators to rethink procedures for testing certain powerful new drugs.

Although tests of TGN1412 in monkeys showed no significant trouble, all six human subjects nearly died. One is still hospitalized and the others, though discharged, still have impaired immune systems, their future health uncertain.

On Wednesday, after releasing its interim report on the trial as well as previously confidential scientific documents that were part of the application for a trial permit, the British government announced it was convening an international panel of experts to "consider what necessary changes to clinical trials may be required" for such novel compounds.

The outcome "could potentially affect clinical trials regulation worldwide," the announcement said.

In statements this week, both Parexel and the drug's manufacturer, TeGenero, emphasized that they had complied with all regulatory requirements and conducted the trial according to the approved protocol. But they declined to answer questions e-mailed to them about the specifics of the science involved.

"The companies have worked according to strict standards applicable for such type of studies," said Kristin Kaufmann, a spokeswoman for TeGenero.

Within an hour of receiving the milky white drug in a Parexel research ward in the hospital on March 13, the volunteers were racked with chills, pain and nausea, said Rob O., who asked that his last name not be used, for fear that he might be hurt professionally. A doctor informed him he was "seriously ill."

"But no one's going to die?" Rob O. recalled saying, believing he was participating in a fairly standard trial of a painkiller for arthritis.

The chilling response: "Two of you might. Who's your next of kin?"

In fact, TGN1412 is anything but standard. The first product of TeGenero, a tiny German company with just 15 employees, TGN1412 belongs to a completely novel class of manufactured antibodies that researchers thought could revolutionize the treatment of leukemia and rheumatoid arthritis.

Now, TGN1412 seems poised to go down in medical history as a pharmaceutical lemon, its disastrous trial raising serious questions about whether patient safety is adequately protected in the lucrative race to get products to market.

The British Medicine and Healthcare Products Regulatory Agency, which approved the trial at Northwick Park, announced Wednesday that "the way the trial was run" had not contributed to patient injuries, according to its preliminary investigation. The men experienced cytokine release syndrome, which involves an outpouring of toxic molecules when the immune system's T cells are activated, the report said; it could not have been predicted from previous animal studies using the drug, the association, TeGenero and Parexel agree.

But British regulators took the highly unusual additional step of appointing an expert panel to explore whether more stringent safeguards should be required for testing new biological drugs like TGN1412 that manipulate the immune system.

Many experts say that because TGN1412's unique property is to turn on potent, immune system T cells, overriding normal regulatory mechanisms, the clinical trials were extraordinarily risky. "There was strong reason to be very cautious," said Dr. Michael Ehrenstein, of University College London, who studies the molecules that TGN1412 affects. "Many people would say this was a very high-risk strategy. I'd have to agree with that."

Michael Goodyear, a Canadian oncologist and medical ethicist, said that even if the trial was not illegal or unethical, the research protocol and conduct on the day of the trial raise "a number of big red flags."

The concerns Dr. Goodyear and lawyers for the subjects raised include these:

¶Rob O. began receiving the drug intravenously long after the first volunteer was already experiencing symptoms possibly serious enough to halt the trial. Standard practice for such trials is to use just one patient or to separate tests by many days.

¶The information submitted by TeGenero to British regulators mentioned that a cytokine burst "could occur" after TGN1412 infusion. But in their application, researchers deemed the reaction "not expected" on the basis of trials with a single animal species, and did not mention this risk to the recruits, Rob O. said.

¶On its Web site, Parexel says, "The only services that matter are the ones that speed your product through clinical development." The subjects point out that approvals for drug trials in Britain are quicker than in the United States and the liability for injuries is less.

¶Rob O. said the novelty of TGN1412 never came up in upbeat pretrial briefings, adding, "I had no idea it altered the immune system."

The first human trials are risky and ethically complicated. They are designed to determine whether a compound is safe, not to provide a benefit to the subject. Such human trials must be approved by national regulators as well as medical ethics boards, though standards vary somewhat among countries and even among different panels.

"Research is a social good ? we need better treatments for leukemia and arthritis ? but there are risks," said Dr. Ezekiel J. Emanuel, chief of bioethics at the United States National Institutes of Health. "Being a construction worker is very risky, and we pay people to do that. So why not this?"

Noting that the TGN1412 trial had been approved by two separate British regulatory bodies and that the medicine had been tested in animals, he said, "This is a terrible, tragic event but so far I don't see any clear ethical problems."

The trial subjects, who were to spend three days as hospital inpatients, were mostly immigrants, some of them students or unemployed.

"These were not people who were well off," said Martyn Day, of the London law firm Leigh Day & Company, which is representing four of the men. "They thought this was relatively risk free."

At the orientation meeting there was little time to read the 11-page consent form, Rob O. said, although they had a chance to take it home. Headaches and bruising were listed as potential side effects, as well as a severe allergy. But eating nuts or using new cosmetics could create similar reactions, the form said.

In fact, so-called monoclonal antibodies frequently produce severe generalized symptoms like aches and chills, though their use is justified by the enormous potential benefit. "At my hospital, we almost killed people the first few times we used Herceptin," said Dr. Goodyear, referring to the popular breast cancer drug, adding that he now pretreats patients with medicines to counter possible reactions.

Parexel applied to test TGN1412 in both England and Germany in December, receiving permission in England first, on Jan. 27. Many countries are streamlining review processes to attract biomedical research, a strategy that may have backfired here, Dr. Goodyear said.

It is not clear if independent immunologists reviewed the trial design, and neither Parexel nor TeGenero answered this question.

The trial began Monday, March 13, at 8 a.m., when the men began receiving TGN1412, each 10 minutes after the last. Within half an hour, the first patient had a headache and chills, said Ann Alexander, a London lawyer who is representing him. Nevertheless, doctors continued injecting new patients. About the time Rob O.'s infusion started, at 9:10 a.m., the first patient had passed out in an adjacent room, according to Ms. Alexander.

Before long, Rob O. said, he began to ache and shiver, feeling as if he had been "submerged in arctic ice." For the rest of the day, six previously healthy men moaned in uncontrollable pain, vomited and struggled for breath, Rob O. and other participants said. Though a dose of steroids temporarily blunted the symptoms, their vital signs steadily deteriorated, and they were transferred to the intensive care unit.

Two of them were placed on ventilators. Uniformed men wheeled in blood filtering machines, Rob O. recalled, to cleanse the blood of acid. Doctors told him that his immune cells were attacking his organs.

The patients' families were summoned to the hospital at 3 a.m.

In statements, Parexel and TeGenero called the reactions "unforeseen and unexpected," noting that doses hundreds of times more powerful had proved safe in animals.

The experimental application filed with British authorities ? released this week in response to a Freedom of Information Act request ? showed that the companies at least realized the possibility of a devastating immune-system reaction, and that animal studies showed some signs of immune overdrive.

Those worries were set aside when monkeys infused with TGN1412 had no problems. Although Parexel technicians continued to draw blood in the intensive care unit, the companies have not been willing to share the medical data or even meet with the participants and their lawyers, Mr. Day, the lawyer, said.

With his immune system now essentially disabled, Rob O. says he cannot work, or even take the subway, for fear of infection. His liver and kidney tests are still abnormal. Britain's National Health Service covers his doctor's bills, but he has to pay the $87 cab fare.

Under British law, Rob O. may be eligible only for $50,000 to $70,000 in compensation, said Mr. Day, unless he can demonstrate permanent harm. Anyway, tiny TeGenero took out only a $3.5 million insurance policy to cover the trial.

Lawyers for the subjects are hoping to arrange for financial compensation and full disclosure of medical information on the drug without having to go to court.

"I can't believe that nobody will pay and nobody will be punished," Rob O. said. "If I've lost 20 years of life because my liver packs in at 60 rather than 80, who will cover that?"

 

http://biz.yahoo.com/prnews/060510/phw003.html?.v=54


Press Release Source: Medarex, Inc.


Oxford Genome Sciences and Medarex Sign Therapeutic Antibody Collaboration Agreement in Cancer
Wednesday May 10, 5:00 am ET


OXFORD, England and PRINCETON, N.J., May 10 /PRNewswire-FirstCall/ -- Oxford Genome Sciences (UK) Ltd "OGeS" and Medarex, Inc. (Nasdaq: MEDX - News) announced today that they have entered into a strategic collaboration to discover and develop new human antibody therapeutics for the treatment of cancers, including colorectal cancer.
ADVERTISEMENT


The collaboration combines OGeS' ability to discover novel targets for oncology with Medarex's expertise in the development of fully human antibody therapeutics. The collaboration provides for OGeS and Medarex to discover, develop and commercialize therapeutic antibodies on a 50:50 basis. Other financial terms of the agreement were not disclosed.

During the initial phase of the collaboration, OGeS intends to provide novel colorectal cancer targets, against which Medarex expects to generate fully human monoclonal antibodies using its proprietary UltiMAb Human Antibody Development System®. OGeS plans to utilize its unique Oxford Genome Anatomy Project (OGAP®) database, one of the world's largest human protein databases that integrates genomic, proteomic and clinical information derived from blood and tissue studies for a large number of diseases from 50 different human tissues and representing 60 diseases.

"I am extremely excited about our partnership with Medarex, a leader in the development of human antibody therapeutics. Their expertise in combination with the unique targets from our OGAP database give me great confidence that we can develop new and improved treatment options for patients with colorectal cancer," said Dr. Christian Rohlff, CEO of OGeS.

"We are very happy to have signed this agreement with OGeS and believe that access to the unique high-quality targets from the OGAP database will allow us to quickly identify novel antibody-based targets for cancer. We are impressed with the capabilities of OGeS' technology for identifying disease targets and look forward to applying our human antibody and clinical development expertise for the development of new cancer treatments," said Donald L. Drakeman, President and CEO of Medarex, Inc.

About Oxford Genome Sciences

Oxford Genome Sciences (OGeS) is focused on the development of personalized medicines, mainly for oncology indications. The company has developed a unique integrated platform that combines genomic, proteomic and clinical information to accelerate the discovery and validation of drug targets and biomarkers in human beings. OGeS believes the benefits are improved biomarkers for patient selection, drug response and efficacy monitoring, and the integration of diagnostics into drug development and product launch, thereby facilitating more accurate drug development and providing cost and time savings.

OGeS's strategy is to enter into flexible strategic alliances to capture maximum value from its unique and integrated platform for the development of new therapeutics and diagnostics in the field of cancer. In parallel, OGeS provides target and biomarker discovery and screening services to pharmaceutical and biotechnology companies providing OGeS with short-term revenues.

OGeS, a privately held company, was formed in 2004 and is based near Oxford, UK.

About OGAP

Oxford Genome Anatomy Project (OGAP) holds one of the world's largest proprietary collection of proteins represented by the database, which contains over one million peptide sequences from 50 tissues and 60 disease states, mapped to approximately 15,000 genes and over eight million SNPs and haplotypes. The database can be customized for individual partners to support and enhance their preclinical and clinical drug development activities.

For further information, please see http://www.oxfordgenomesciences.com.

About Medarex

Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb® technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. Thirty-one of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with four of the most advanced product candidates currently in Phase III clinical trials. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. For more information about Medarex, visit its website at www.medarex.com.

Medarex Statement on Cautionary Factors

Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of antibody products in patients, uncertainties related to product manufacturing as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex's public disclosure filings are available from its investor relations department.


   OGAP® is a registered trademark of Oxford Genome Sciences (UK) Ltd.
Medarex®, the Medarex logo and UltiMAb® are registered trademarks of Medarex, Inc. All rights are reserved.




--------------------------------------------------
Source: Medarex, Inc.



 

http://de.biz.yahoo.com/24052006/217/...-fruehstadium-zugelassen.html


PR Newswire
Herceptin in Europa bei HER2-positivem Brustkrebs im Frühstadium zugelassen
Mittwoch 24. Mai 2006, 07:35 Uhr

                    §
LONDON, May 24 /PRNewswire/ --
- Lebensverlängerndes Medikament lässt Frauen mit aggressiver Form von
Brustkrebs in ganz Europa wieder hoffen

Roche gab heute bekannt, dass die Europäische Kommission Herceptin
(Trastuzumab) für Patientinnen mit HER2-positivem Brustkrebs im Frühstadium
im Anschluss an eine Operation und Standard-Chemotherapie zugelassen hat.
HER2-positiver Brustkrebs, der etwa 20 bis 30 Prozent [i] aller Frauen mit
Brustkrebs befällt, erfordert besondere und unmittelbare Aufmerksamkeit, da
die Tumoren schnell wachsen und eine gesteigerte Rezidivwahrscheinlichkeit besteht.

Die Zulassung basiert auf eindrucksvollen Ergebnissen aus der
internationalen HERA-Studie

(HERceptin Adjuvant), derzufolge die Verabreichung von Herceptin im
Anschluss an die Standard-Chemotherapie im Vergleich zur ausschliesslichen
Chemotherapie das Rückfallrisiko des Krebses um 46% reduziert. [ii]
Gleichermassen bemerkenswerte Vorteile wurden auch bei drei anderen grossen
globalen und US-amerikanischen Studien beobachtet. [iii]

"Es ist lobenswert, dass die Zulassung von Herceptin für Brustkrebs im
Frühstadium in Europa so erstaunlich rasch abgewickelt wurde", so der
Kommentar von William M. Burns, CEO der Pharmazeutischen Abteilung von Roche.
"Herceptin hat eindeutig bewiesen, dass es die besten langfristigen
Überlebenschancen bietet, wenn es möglichst zu Beginn des Krankheitsverlaufs
angewendet wird. Diese Entscheidung bedeutet wirklich gute Nachrichten für
Patienten und die medizinische Gemeinde. Wir werden jetzt mit den nationalen
Behörden zusammenarbeiten, damit den Ärzten und Patienten in ganz Europa
diese Behandlungsmethode garantiert zugänglich ist."

Herceptin war zuvor in der EU zur Behandlung von metastasiertem
(fortgeschrittenem) HER2-positiven Brustkrebs zugelassen worden. Diese neue
Genehmigung gestattet es nun Frauen in jedem Stadium dieser aggressiven
Krankheit, einschliesslich Brustkrebs im Frühstadium, diese
lebensverlängernde Behandlungsoption zu nutzen.

Die Beständigkeit der Ergebnisse aus vier grossen Versuchen mit über
12.000 Patientinnen hat medizinische und behördliche Organisationen auf der
ganzen Welt bewogen, schnelle Massnahmen zu ergreifen, damit Herceptin
Patientinnen mit HER2-positivem Brustkrebs im Frühstadium zur Verfügung
steht. Herceptin erhielt vor kurzem den Zulassungsstatus in Neuseeland und
Australien, und mehrere Länder haben im Lauf des letzten Jahres vor Erteilung
der Lizenz klinische Richtlinien entwickelt und Mittel bereitgestellt, um in
Frage kommenden Patienten einen schnelleren Zugang zu gewähren.

In den USA hat Genentech am 15. Februar 2006 bei der Food and Drug
Administration (FDA) einen zusätzlichen Antrag auf biologische Zulassung
(Biologic License Application = sBLA) zur Anwendung von Herceptin bei
HER2-positivem Brustkrebs im Frühstadium gestellt. Dieser Antrag basiert auf
Daten aus der kombinierten Zwischenanalyse von zwei grossen US-Versuchen
[iv], und Genentech hat einen vorrangigen Prüfungsstatus erreicht.

Informationen zur HERA-Studie

HERA, von Roche und der Breast International Group (BIG) durchgeführt
[v], ist eine der umfangreichsten adjuvanten Studien an
Brustkrebspatientinnen überhaupt; die Registrierung begann im Dezember 2001,
und es wurden beinahe 5.100 HER2-positive Patientinnen in 480
Untersuchungsstandorten in 39 Ländern weltweit aufgenommen. HERA ist ein
randomisierter Versuch im Anschluss an die herkömmliche systemische
Begleitchemotherapie und (gegebenenfalls) Strahlenbehandlung, bei dem
Beobachtung (also keine weitere Behandlung) versus Herceptin alle drei Wochen
für einen Zeitraum von 12 Monaten oder 24 Monaten bei Frauen mit
HER2-positivem Brustkrebs im Frühstadium bewertet wird. Die HERA-Studie liess
die Anwendung einer breiten Palette an chemotherapeutischen Verfahren zu, und
sowohl lymphknotenpositive wie auch lymphknotennegative Patientinnen wurden
zu dem Versuch zugelassen.

Gemäss den Ergebnissen der Zwischenauswertung wurde der primäre Endpunkt
der Wirksamkeit erreicht. Es wurde nachgewiesen, dass Patienten, die
Herceptin erhalten hatten, im 12-monatigen Arm der Studie eine statistisch
signifikante Verbesserung des krankheitsfreien Überlebens erfuhren (darunter
versteht man die Zeitspanne nach der Behandlung, während der keine
Krankheitsanzeichen auftreten). Bei einer medianen Nachbeobachtung von einem
Jahr hatte der sekundäre Endpunkt des Gesamtüberlebens noch keine
statistische Signifikanz erreicht. Es war allerdings eine eindeutige Tendenz
zur Verbesserung des Gesamtüberlebens zu beobachten, was durch längerfristige
Daten noch zu bestätigen sein wird.

Die Zwischenanalyse verglich Herceptin mit reiner Beobachtung und schloss
keine Gegenüberstellung der 12-monatigen mit der 24-monatigen
Behandlungsdauer ein. Der Versuch wird diesen Vergleich weiterhin bewerten,
die entsprechenden Daten werden im Verlauf der Studie zum gegebenen Zeitpunkt
verfügbar sein.

Die HERA-Studie untersteht einem externen Datenkontrollausschuss
(Independent Data Monitoring Committee = IDMC), der regelmässig die
Unbedenklichkeitsfaktoren der Studie überprüft. Bisher hat das IDMC bezüglich
der Sicherheit keine Bedenken geäussert, und das Auftreten von kongestiver
Herzinsuffizienz war geringfügig (0,5% beim Herceptin-Arm versus 0% beim
Beobachtungs-Arm). Die Patientinnen dieser Studie werden weiterhin auf
eventuelle Nebenwirkungen hin überwacht.

Informationen zu Brustkrebs und Herceptin

Acht bis neun Prozent aller Frauen erkranken im Lauf ihres Lebens an
Brustkrebs, was diesen zu einer der häufigsten Formen des Krebses bei Frauen
macht. [vi] Alljährlich werden weltweit über eine Million neuer Fälle von
Brustkrebs diagnostiziert, wobei die Sterberate bei fast 400.000 pro Jahr
liegt.

Beim HER2-positiven Brustkrebs befinden sich erhöhte Mengen des
HER2-Proteins an der Oberfläche der Krebszellen, was als 'HER2-positiv'
bezeichnet wird. Hohe Konzentrationen von HER2 sind bei einer besonders
aggressiven Form der Krankheit vorhanden, die nur schlecht auf Chemotherapie
anspricht. Untersuchungen haben ergeben, dass etwa 20 - 30 Prozent aller
Frauen mit Brustkrebs HER2-positiv sind.

Herceptin ist ein humanisierter Antikörper, der gezielt die Funktion von
HER2 blockieren soll. HER2 ist ein Protein, das von einem bestimmten Gen mit
krebsverursachendem Potenzial produziert wird. Abgesehen von der Wirksamkeit
bei Brustkrebs im Frühstadium hat Herceptin auch verbessertes Überleben im
fortgeschrittenen (metastasierten) Stadium unter Beweis gestellt, wo die
Kombination mit Chemotherapie im Vergleich zur Chemotherapie allein den
Patientinnen eine bis zu einem Drittel längere Überlebenszeit gewährt. [vii]

Herceptin wurde im Jahr 2000 in der Europäischen Union zur Anwendung bei
Patientinnen mit metastasiertem Brustkrebs zugelassen, deren Tumore einen
Überschuss des HER2-Proteins aufwiesen. Neben der Anwendung in Kombination
mit Docetaxel als Erstlinientherapie für HER2-positive Patienten, die keine
Chemotherapie für ihre metastasierte (fortgeschrittene) Krankheit erhalten
hatten, ist Herceptin auch als Erstlinientherapie in Kombination mit
Paclitaxel angezeigt, wenn Anthrazykline ungeeignet sind, sowie als
Monotherapeutikum bei der Drittlinientherapie. Herceptin wird in den
Vereinigten Staaten von Genentech, in Japan von Chugai und in den übrigen
Ländern von Roche vertrieben. Herceptin wurde seit 1998 zur Behandlung von
über 230.000 HER2-positiven Brustkrebspatientinnen weltweit eingesetzt.

Unternehmensprofil Roche

Das Unternehmen Roche mit Hauptsitz im schweizerischen Basel ist einer
der weltweit führenden, forschungsorientierten Gesundheitskonzerne im
Arzneimittel- und Diagnostikbereich. Mit innovativen Produkten und
Dienstleistungen, die der Früherkennung, Prävention, Diagnose und Behandlung
von Krankheiten dienen, trägt der Konzern auf breiter Basis zur Verbesserung
der Gesundheit und Lebensqualität der Menschen bei. Roche steht weltweit an
der Spitze auf dem Gebiet der Diagnostik, ist der führende Anbieter von
Krebs- und Transplantationsmedikamenten und ist marktführend auf dem Gebiet
der Virologie. Im Jahr 2005 erzielte die Pharmaabteilung einen Gesamtumsatz
von 27,3 Mrd. Schweizer Franken, die Diagnostik-Abteilung verzeichnete
Umsätze in Höhe von 8,2 Mrd. Schweizer Franken. Roche beschäftigt rund 70.000
Mitarbeiter in 150 Ländern und unterhält Forschungs- und Entwicklungsabkommen
sowie strategische Allianzen mit zahlreichen Partnern. Das Unternehmen
verfügt unter anderem über Mehrheitsbeteiligungen an Genentech und Chugai.
Weitere Informationen über den Roche Konzern finden Sie im Internet
(www.roche.com).

Alle in dieser Pressemitteilung verwendeten bzw. erwähnten Markennamen
sind gesetzlich geschützt.

Zusätzliche Informationen:

- Über Genentech: www.gene.com

- Roche in Oncology:

www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk über Krebs: www.health-kiosk.ch/start_krebs

- Videoclips (kostenlose Standardübertragung): www.thenewsmarket.com

Quellenangaben:

[i] Harries M, Smith I. The development and clinical use of trastuzumab
(Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

[ii] Piccart-Gebhart M, Procter M, Leyland-Jones B, et al. A Randomized
Trial of Trastuzumab Following Adjuvant Chemotherapy in Women with HER2
Positive Breast Cancer. New England Journal of Medicine 353:16 2005.

[iii] NCCTG N9831 (US), NSABP B-31 (US), BCIRG 006 (international)

[iv] Romond, E., Perez, E. et al. Trastuzumab plus Adjuvant Chemotherapy
for Operable HER2 Positive Breast Cancer. New England Journal of Medicine
353:16 2005.

[v] Collaborative partners for the HERA study include: Roche, BIG and its
affiliated collaborative groups, plus non-affiliated collaborative groups,
and independent sites.

[vi] World Health Organization, 2000.

[vii] Extra JM, Cognetti F, Maraninchi D et al. Long-term survival
demonstrated with trastuzumab plus docetaxel: 24-month data from a randomised
trial (M77001) in HER2-positive metastatic breast cancer. Abstract #555,
American Society for Clinical Oncology (ASCO) Annual Meeting 2005.
Roche