Generex Biotech Corp

Generex Biotechnology announces plan to obtain cost reimbursement coverage for Generex Oal-lyn
19. April 2010 12:01

Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has established an action plan for obtaining cost reimbursement coverage for Generex Oal-lynÂ?, including the development of an insurance product that covers the costs of Generex Oral-lynÂ? and any additional and/or comparable diabetes products.

Some of the objectives in the action plan will include: the creation of a prospectus for use with Insurance Underwriters; the development of cost and risk assessment profile; identifying potential underwriters; and the creation of supporting actuarial and marketing materials.

In order to implement this program, the Company has engaged the consulting services of David Brusegard, Ph.D., an individual with extensive experience in designing and marketing health related insurance and financial products.   Most recently, Dr. Brusegard served as the CEO of the Pentius Group, a 5-company group involved in designing and marketing health and travel insurance and financial products in North America. Pentius was a consolidated health Managing General Agent (MGA) and Managing Underwriter (MGU) and provided a full service Third Party Administration (TPA) capability to the insurance and health oriented financial industries. As such, Pentius employed nurses and doctors for health insurance based managed care. Dr. Brusegard was responsible for all aspects of database development and analysis at Pentius as well as operational and strategic management. As CEO, he grew the company rapidly and culminated its growth with a sale to a large insurance conglomerate.

The Generex Oral-lynÂ? cost reimbursement plan will apply to existing and future regulatory approvals for Generex, as well as the Company's United States Food and Drug Administration (FDA) Expanded Access Treatment IND program.

The FDA's Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing.

Under the Expanded Access Treatment IND program, Generex Oral-lynÂ? will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the Company's ongoing global Phase III pivotal clinical trial of the product.

This Treatment IND is open to eligible patients that comply with the inclusion/exclusion criteria of the treatment protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this IND program.

The Company continues to work with its key strategic relationships under the Treatment IND Program in the US for Generex Oral-lynÂ? including Assured Pharmacy, which will provide Generex Oral-lynÂ? dispensary services to health practitioners and patients in the program. Assured Pharmacy will also undertake the enrollment of family physicians, endocrinologists, and nurse practitioners in the program. TS Biopharma, a multi-tiered pharmaceutical development services organization, will continue to assist in mounting a recruitment campaign for the participation in the program consisting of physicians, nurse practitioners and patients. Health Management Resources is also participating in the program recruitment activities.  

Generex Biotechnology Achieves Enrollment of Over 400 Subjects in Phase III Generex Oral-lyn(TM) Stu
 
May 10, 2010
 
Generex Biotechnology Achieves Enrollment of Over 400 Subjects in Phase III Generex Oral-lyn(TM) Study

WORCESTER, Mass., May 10, 2010 (GlobeNewswire via COMTEX News Network) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has achieved enrolled of over 400 subjects in its pivotal global Phase III study of its flagship product, Generex Oral-lyn(TM), a proprietary buccal insulin spray product designed to replace prandial injections of insulin.

Generex will continue to monitor and execute the ongoing Generex Oral-lyn(TM) study according to protocol and national/international ICH-GCPs. The study's endpoint is for Generex Oral-lyn(TM) to achieve non-inferiority to injectable meal-time (prandial) insulin. Formal verification of the non-inferiority hypothesis should be achieved by the statistical power set out in the protocol. Following the execution of the study's first interim analysis in approximately two months, the enrollment of additional subjects in the study may possibly be terminated. This in turn would establish an approximate end-of-study-treatment-period in December 2010.

To date, no Generex Oral-lyn(TM) drug-related "Serious Adverse Events" (SAEs) have been reported, which also supports the current initiatives of the study.

"We are pleased with the progress of the Phase III study for Generex Oral-lyn(TM) to date in each of the global sites," said Anna Gluskin, Generex's President & Chief Executive Officer. "We remain confident that the results of this pivotal global study will remain consistent with all historical studies of our flagship product that have been successfully conducted to date. The results will form the basis of our upcoming NDA submission in the US. In parallel, to help Americans today that have Type 1 or 2 Diabetes who cannot use injectable insulin, treatment use of Generex Oral-lyn(TM) will continue under the FDA's expanded access Treatment IND program until the upcoming filing of an NDA is approved. We are excited to know that this select population can be assisted until that goal is achieved."

The Company believes that Generex Oral-lyn(TM) offers a safe, simple, fast, effective and needle-free alternative to prandial insulin injections which will improve patient compliance with therapeutic regimens, thereby delaying the progress of diabetes and the onset of its myriad complications.

About Generex Biotechnology Corporation

Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, buccal insulin (Generex Oral-lyn(TM)), which has been approved in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831

Safe Harbor Statement

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Generex Biotechnology Corp.

CONTACT: American Capital Ventures, Inc.
Investor Relations Contact:
Howard Gostfrand
1-877-918-0774
Beckerman Public Relations
Media Contact:
Christina Brozek
201-465-8002  

http://www.marketwatch.com/story/...r-2010-05-18?reflink=MW_news_stmp  

Hallo kollegen,

anscheinend scheint sich die Aktien nun in USA zu bewegen, positive Meldung am 28.07.2010 es wird Zeit das sich nun die wirklich gesunde Firma auf den Weg macht ihr Produkt auf den Markt zu bringen. Was meint ihr dazzu??

Dies ist keine Aufforderung nur meine persönliche Meinung.

 

 

                                                                                                                                                                                                                                                                                                                                       

Generex Provides Positive Update on Generex Oral-lyn™ Pivotal Phase III Trial

July 28, 2010

Generex Provides Positive Update on Generex Oral-lyn™ Pivotal Phase III Trial Study has now achieved 75% of the required number of per-protocol completers WORCESTER, MA, July 28, 2010 (GlobeNewswire) – Generex Biotechnology  Corporation (NasdaqCM:GNBT, www.generex.com), the leader in drug  delivery for metabolic diseases through the inner lining of the mouth,  today announced that it has now achieved 75% of the required number of  per-protocol completers in its ongoing six month pivotal global Phase  III study of Generex Oral-lyn™, the Company’s proprietary buccal insulin  spray product.  These early results suggest that, should the current  trend be maintained through the early 2011 completion date of the  treatment phase of all enrolled subjects, the use of Generex Oral-lyn™  will support a non-inferiority claim relative to the standard-of-care  injectable insulin.  This position will be reviewed following a formal  interim analysis after the 90-day results for all subjects become  available. It is gratifying for the Company to see a continuum of positive trends.   Initial trending outcomes revealed that insulin resistance was not  observed for subjects using Generex Oral-lyn™ and that subjects using  Generex Oral-lyn™ demonstrated, on average, no weight gain and an actual  decrease in Body Mass Index (BMI).  This compared favorably to subjects  using injectable insulin that have, on average, gained weight and  experienced an increase in BMI.  In addition, it was previously reported  that when comparing hypoglycemic events, subjects using Generex  Oral-lyn™ were observed to have a better Adverse Event profile than  subjects using injectable insulin.  These previous findings along with  current trends of non-inferiority using recently collected information  and extrapolations clearly positions this study favorably. “This latest study trend is exciting news for us,” said Anna Gluskin,  the Generex President & Chief Executive Officer.  “The Phase III  study is on track and we will look forward to further analyses as we  near completion of the study.”

Deswegen wahrscheinlich die 11 % Steigerung am Freitag in den USA

Keine Aufforderung nur persönliche Meinung

 

http://www.benzinga.com/pressreleases/10/07/...-announces-agm-results  

http://seekingalpha.com/article/...generex-reverse-split-not-approved  

NLS Time (ET) NLS Price NLS Share Volume
16:00:01  $ .40   150,000
15:59:59   $ .40   300
15:59:56  $ .40   4,250
15:59:56   $ .40   750
15:59:50  $ .40   1,100
15:59:49   $ .40   1,600
15:59:49  $ .40   8,000
15:59:49   $ .40   3,000
15:59:49  $ .40   22,409
15:59:49   $ .40   2,591



Read more: http://www.nasdaq.com/aspx/...ol=GNBT&selected=GNBT#ixzz0vR5gkfoL  

Trotzdem ist sie mit 0,33 in Dtl. zu teuer ý 0,4:1,3 = 0,31

 

 

bis du jetzt zufrieden, jetzt ist es aktuell auf 0,31 in FRA. du kannst jetzt einkaufen. :-))

Wobei man sollte es wissen für GNBT wird der Kurs in NYSE gemacht und nicht in D.  

Nachdem die Shareholders auf der HV einen ReSplit abgelehnt haben, weil nur die Anzahl der ausgegebenen Shares aber nicht die Anzahl der autorisierten Shares geresplitet werden sollten, muss man jetzt abwarten wie auf das mögliche Nasdaq delisting reagiert wird. Das Management wollte ja deswegen den ReSplit um den Aktienpreis über 1 Dollar zu bringen, nur hätte der eine massive Verwässerung bedeutet, denn nach dem ReSplit hätten gleich wieder neue Aktien ausgegeben können...
Sollte ein delisting kommen und danach an der OTC gehandelt werden, wird es wohl eine Menge Zocker anziehen und fürs erste Versuchen den Preis zu drücken...
Ich werde erstmal Generex auf der Watchlist belassen und abwarten wie das Management auf die Abfuhr bei der HV reagiert...  

Betrachtet man die in letzter Zeit veröffentlichten Berichte über Generex Biotechnology bezüglich der "Delistung" des Unternehmens aus dem NASDAQ (http://www.generex.com/...release_desc.php?id=184&year=MjAxMA==), sowie die erst kürzlich fehlgeschlagenen "Rückwärtssplit" (http://www.generex.com/...release_desc.php?id=186&year=MjAxMA==), so stehn die Chancen sehr gut, dass der Wert der Aktie sich in den nächsten Tagen verdoppeln, wenn nicht verdrei-bis vervierfachen wird.

Der Grund ist, dass Unternehmen an der NASDAQ bestimmte Kriterien erfüllen müssen, um gelistet zu werden. Das gemeinte Kriterium ist auf der Homepage des Unternehmens einsehbar (http://www.generex.com/...release_desc.php?id=172&year=MjAxMA==). Dort steht deutlich, dass der Wert der Aktie über einem Dollar liegen sollte, um weiterhin an der NASDAQ gelistet zu werden und um nicht im OTC BB zu landen ("Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) today  announced that on May 6, 2010 the Company was notified by the NASDAQ  staff that the Company is not in compliance with the $1.00 minimum bid  price requirement in Listing Rule 5550(a)(2) (the Company remains in  compliance with all other listing maintenance requirements).")

Der aus diesem Grund zur Abstimmung gestellte "reverse split" wurde von den Aktionären nicht mitgetragen (s.o), so dass die einzige Möglichkeit nun in der Erhöhung des Aktienkurses, durch Nachfrageerhöhung der Aktie liegt.

Gegeben dieser Tatsache, sollte der Kurs in kürzester Zeit, mit Berücksichtigung des aktuellen Wechselkurses ca. 79 Euro-Cent erreichen (1$/1,27=0,787). Dadurch rechtfertige ich die Kursverdopplung. Die Verdrei- bzw. Vervierfachung ist aus dem Herdenverhalten der Anleger bzw. Spekulationen, die mit solchen Kurserhöhungen gewöhnlich einhergehen, abzuleiten.

 

:::Dies ist keine Aufforderung zum Kauf oder Verkauf:::

 

Aus Post #212 ist daher ein kurzfristiger Kursgewinn von min. 100% möglich!

:::Dies ist keine Aufforderung zum Kauf oder Verkauf:::

 

dass die Aktie einfach aus dem Nasdaq rausgeschmissen wird, weil die Kriterien für ein Listing dort nicht erfüllt sind?

Ich gehe statt von einer Kurssteigerung eher von einem weiteren Kursrückgang aus.

 

 

Wie gestern in #215 geschrieben, denke ich nicht, dass Generex so leicht as dem NASDAQ gehen will aufgrund folgender Statements:

"As our clinical results continue to be positive, and as we are now listed on NASDAQ, we expect to start receiving increased interest from the financial community at large." (2000: http://www.twst.com/ceos/gnbt.html)

""I am pleased to see that the Panel recognized the opportunities  available to the Company through prospective business events and gave us  the opportunity to remain listed on The NASDAQ Stock Market," said Anna  Gluskin, the Company's President & Chief Executive Officer." (2010 http://www.streetinsider.com/Corporate+News/...mination/5808341.html)

"The proposal for a reverse stock split was not approved at the meeting.  The company stated in a press release today that "In an effort to  prevent the Company's common stock from being delisted, the Company has  requested that the Nasdaq Hearings Panel grant the Company additional  time to hold a special meeting of the stockholders at which the  requisite stockholder votes to approve the Amendment will be sought. To  achieve the requisite votes, the Company will work with its proxy  solicitation agent, Morrow & Co., LLC, to design and implement an  aggressive, targeted solicitation strategy. The Company cannot be  certain that the Panel will grant the Company's request." The feeling I  have from the meeting is that the company does not actually want to  implement such a split, and is trying to buy time to remain listed on  NASDAQ as they continue with their business plan." (http://pipelinereview.blogspot.com/2010/07/generex-asm-update.html)

 

Für mich entsteht beim Lesen dieser Passagen der Eindruck, dass das Unternehmen nicht aus dem NASDAQ will, worauf ich meine gestrige Aussage (in #215) gestützt habe.

 

Wie lange hat Generex noch Zeit um die Nasdaq-Anforderungen zu erfüllen ?  

Welches UN will wohl aus dem Nasdaq raus ? Erklärung bitte für welches seriöses UN das von Interesse sein könnte ?

Also aus dieser Aussage den zukünftigen Wert abzuleiten scheint mir schwierig, oder investiert deswegen etwa die GF in den eigenen Wert ohne, dass ein Kurs über $1 fundamental gerechtfertigt wäre?

Mir nur recht wenns so wäre, aber ich wäre dann sofort raus, so dass das Problem in 2 Monaten sofort wieder auftritt....

 

@Bayernland1: Keine Ahnung, da ich erst vor Kurzem selbst durch einen Beitrag (s.o.) hier drauf gekommen bin und die Idee kam mir morgens beim Aufwachen (gestern).

Da müsstest Du bei den NASDAQ-Regeln nachschauen.

@bushaltefolie: Natürlich nicht, jedoch musste ich meine Aussage mit Quellen belegen, da diese ohne gelöscht wurde.

Ich bin in dieser Hinsicht auch recht skeptisch, ob der Kurs in die Höhe schiesst, jedoch war meine letzte "Ahnung" beim Aufwachen auch recht fruchtbar :)

 

Ich sage ja nicht, dass man einsteigen soll oder dass an dieser Idee was dran ist...

 

... /PRNewswire/ -- Generex Biotechnology Corporation (Nasdaq:GNBT  - News),

(www.generex.com),  the leader in drug delivery for metabolic diseases through the inner  lining of the mouth, today announced that it has entered into a sales  agreement with Elias Shaker & Company (www.eliasshaker.com),  a leading national full-service consumer product brokerage firm, to  represent Generex's novel consumer products to national and regional  retail and wholesale accounts in the USA.

 

Founded  in 1924 by Elias Shaker, the company has established itself as a  respected, quality-conscious, service-driven organization committed to  producing measurable results.  Elias Shaker & Company has  established relationships with all class of trades from national drug  chains and wholesalers to mass merchandisers/club stores, grocery  chains, food wholesalers, convenience stores and distributors and  specialty stores, representing a total of more than 200,000 retail  points of purchase throughout the USA.

"We  are very excited to partner with an experienced and results-driven  sales firm such as Elias Shaker to represent our proprietary consumer  products in the USA," said Rose Perri, the Company's Chief Operating  Officer.  "We welcome the opportunity to have our products showcased and  represented by a company with an extensive history in retail."

"After  reviewing Generex's consumer products, its current distribution and  discussing it with our sales team internally we are very confident in  taking their product-line to the next level by focusing on building new  distribution, supporting established accounts and taking advantage of  unique promotional opportunities that may arise which will ultimately  grow brand awareness and sales," said Bruce Funk,  Elias Shaker & Company's President.

Elias Shaker &  Company will market and sell the following Generex consumer products:   Glucose RapidSpray™ (www.GlucoseRapidSpray.com),   Crave-NX™ Diet Aid Spray (www.Crave-NX.com),  BaBOOM!™ Energy Spray (www.BaboomEnergySpray.com),  and Glucose RapidSpray™ for Pets (www.GlucoseRapidSprayPets.com).

About  Generex Biotechnology Corporation

Generex is engaged in the  research, development and commercialization of drug delivery systems and  technologies.  Generex has developed a proprietary platform technology  for the delivery of drugs into the human body through the oral cavity  (with no deposit in the lungs).  The Company's proprietary liquid  formulations allow drugs typically administered by injection to be  absorbed into the body by the lining of the inner mouth using the  Company's proprietary RapidMist™ device.  The Company's flagship  product, buccal insulin (Generex Oral-lyn™), which has been approved in India, Lebanon,  Algeria, and Ecuador  for the treatment of subjects with Type-1 and Type-2 diabetes, is in  Phase III clinical trials at several sites around the world.  Antigen  Express, Inc. is a wholly owned subsidiary of Generex.  The core  platform technologies of Antigen Express comprise immunotherapeutics for  the treatment of malignant, infectious, allergic, and autoimmune  diseases.  For more information, visit the Generex website at www.generex.com  or the Antigen Express website at www.antigenexpress.com.

About  Elias Shaker & Company

Founded in 1924 by Elias Shaker,  Elias Shaker & Company is one of the leading consumer products  broker, sales and marketing Service companies in the USA.  The Company has established itself as a  respected, quality-conscious, service-driven organization committed to  producing measurable results.  As a full-service consumer product  brokerage firm, the Company expertly provides a variety of professional  sales and marketing services to the retail and wholesale trades.  Over  85 years, the Company has earned a reputation for producing maximum  sales results and providing outstanding services to both our  manufacturing principals and retail accounts and has successfully  generated millions of additional sales dollars for representative  manufacturing companies.  The Company markets and sell to thousands of  major retail and wholesale outlets and establishments, represented many  leading consumer product manufacturers and their products and received  numerous honors for exceptional sales performance and marketing success.   For more information, visit the Elias Shaker & Company at www.eliasshaker.com.

Safe  Harbor Statement

This release and oral statements made from  time to time by Generex representatives in respect of the same subject  matter may contain "forward-looking statements" within the meaning of  the Private Securities Litigation Reform Act of 1995.  These  statements can be identified by introductory words such as "expects,"  "plans," "intends," "believes," "will," "estimates," "forecasts,"  "projects," or words of similar meaning, and by the fact that they do  not relate strictly to historical or current facts. Forward-looking  statements frequently are used in discussing potential product  applications, potential collaborations, product development activities,  clinical studies, regulatory submissions and approvals, and similar  operating matters. Many factors may cause actual results to differ from  forward-looking statements, including inaccurate assumptions and a broad  variety of risks and uncertainties, some of which are known and others  of which are not.  Known risks and uncertainties include those  identified from time to time in the reports filed by Generex with the  Securities and Exchange Commission, which should be considered together  with any forward-looking statement.  No forward-looking statement is a  guarantee of future results or events, and one should avoid placing  undue reliance on such statements.  Generex undertakes no obligation to  update publicly any forward-looking statements, whether as a result of  new information, future events or otherwise.  Generex cannot be sure  when or if it will be permitted by regulatory agencies to undertake  additional clinical trials or to commence any particular phase of  clinical trials.  Because of this, statements regarding the expected  timing of clinical trials cannot be regarded as actual predictions of  when Generex will obtain regulatory approval for any "phase" of clinical  trials.  Generex claims the protection of the safe harbor for  forward-looking statements that is contained in the Private  Securities Litigation Reform Act.

 

Quelle: finance.yahoo.com/news/Generex-Announces-Sales-prnews-2234593026.html

aktueller Realtimekurs: 0,52 US$ (Quelle: http://finance.yahoo.com/q?s=GNBT )

 

SEC hat Generex eine Fristverlängerung gewährt, so dass über den Reversesplitt am 15. Oktober entschieden werden kann. Damit ist in etwa der Zeitpunkt fest, bis wann Generex Zeit hat die Kriterien (speziell 1 US$ Kurs) nachzuerfüllen.

 

Quelle: Generex

 

.../PRNewswire/ -- Generex Biotechnology Corporation (Nasdaq:GNBT - News) (www.generex.com),  the leader in drug delivery for metabolic diseases through the inner  lining of the mouth, today announced that it is presenting study results  at the 46th Annual Meeting of the European Association for the Study of  Diabetes (EASD, www.easd.org)  being held in Stockholm, Sweden, 20 - 24 September, 2010 (www.easd2010.com).

An  abstract entitled No Generation of Insulin Antibodies in Subjects  with Impaired Glucose Tolerance Treated With Buccal Spray Insulin is  a poster presentation at the symposium.  The abstract is authored by  physicians from the Endocrinology and Diabetes Department, University  "Campus Bio-Medico" and the Diabetes Department, Hospital "St. Pertini",  both of Rome, Italy.

The  abstract presents data from a study demonstrating that treatment with  the Company's propriety buccal insulin spray product, Generex Oral-lyn™,  is a valuable tool for managing hyperglycaemia in subjects with  impaired glucose tolerance.  "There is little doubt that the imperative  for treating impaired glucose tolerance is mounting across the diabetes  universe. This study adds another measure of safety to the use of buccal  delivery of insulin to achieve this goal" commented Dr. Gerald Bernstein, Generex's Vice-President for  Medical Affairs.

The EASD Annual Meeting, which brings together  more than 14,000 delegates in the healthcare industry, is a premier  platform for professional exchange in the field of diabetes. The EASD  brings together scientists, physicians, laboratory workers, nurses, and  students from all over the world who are interested in diabetes and  related subjects.

 

Quelle: yahoo.com

 

The valuation of small development companies is always a bit of a  challenge.   While I am not necessarily surprised by the low share price  of Generex (GNBT)  because of the things  managements of small development companies have to do to raise money to  continue the research, I submit the prospects of small companies, in  this case Generex, are not nothing, which is close to market's recent  valuation.

For the stock market, there appears to be no continuum  to valuations, which seems a bit irrational.

The day before the  FDA announcement, Dendreon (DNDN)  was worth $400 million at its low point in 2009, and now currently bears  a market cap of $6 billion.  Next to this valuation Generex's little  over a hundred million market cap (a measly 2% of DNDN's, is, in any  practical discussion, nothing, or next to it.  Perhaps there was not  enough information prior to make more of a continuum evalutation in  Dendreon's case, but I think there is such a case to be made for  Generex.  But even so, Dendreon's pre-event valuation was three or four  times Generex's current valuation.

Generex has a market cap of  only $126 million.  It is working on a prostate vaccine, which worked so  well for Dendreon, but also a vaccine for breast cancer, avian and  swine flus, ovarian cancer, and melanoma.

But this is not even  their main push, which is a drug delivery system in which drugs are  passed to the blood system via the buccal tissue inside the mouth.   Their test case is insulin.  Recent testing demonstrated that insulin  passed to the blood system through the inside-the-mouth route did not  generate antibodies.  Antibodies are the body's way of rejecting a  substance and in diabetes this is called insulin resistance.  Good news  for this start-up.

If the test case works, then this technique may  be applied to many other drugs.  The message boards were rampant with  the notion that Pfizer (PFE) might want to buy Generex just to develop a  spray for Viagra that would become effective much quicker than the half  hour it takes now, and give them some additional patent protection  time.

Certainly, Generex deserves to be rated at the $400 million  of the pre-approval Dendreon.  I would argue it deserves to rated at  considerably more, perhaps twice as much.

Mannkind (MNKD)  is working on many of the same kinds of things as Generex, but it has a  market cap of $690.  That's five times the market cap of Generex.  It  is also working on the problem of insulin delivery.  But theirs is a  much, much riskier proposition.  First, Mannkind must get FDA approval  of its drug Affreza, Generex does not need any drug approval, it is  using regular insulin.  But even more risky than this is that Mannkind's  scheme uses absorption through the lung.  Pfizer had a drug for lung  absorption, Exubera, but they shelved it, and wrote down a staggering  $2.8 billion because patients were not inclined to use it.  Generex's  offering Ora-lyn does not go in the lungs.

Mannkind is also  working on cancer vaccines.  I cannot speak to their program, but I can  say that the head of cancer drugs for Pfizer, Dr. Craig Eagle, has begun  to advise Generex on its cancer vaccine program.

To be fair, we  sometimes get fooled.  I had invested in Northfield Labs  because it had  a blood substitute based on the hemoglobin molecule, the  base blood  molecule, but it failed to meet a non-inferiority test of  blood plus  saline.  It worked pretty well, but it did not meet that  test.  (I'm  not going to get into a discussion of the FDA's methods.   But what if  blood plus saline is not available?  Then "pretty well" might be a good  thing to have.)

If Ora-lyn fails, this will be a horrible day for  diabetics, and horrible day for Generex stockholders, though at current  levels, not that horrible.  They still have the vaccines.  And if the  vaccine fails for cancer, it may still work for avian flu or swine flu,  and that may still make the company more valuable than Mannkind.

And  that's my contention, Generex is worth at least as much as Mannkind,  which would make Generex worth $2.60 per share.  Now.  Today.  And I  think it's worth more.  To reiterate, its risk on the insulin product is  one third of Mannkind's (no drug approval needed, and not going to the  lung).  By rights, it's worth a good deal more than Mannkind.

Quelle: Thomas Bernard

 

.../PRNewswire/ -- Generex Biotechnology Corporation (Nasdaq: GNBT, www.generex.com),  the leader in drug delivery for metabolic diseases through the inner  lining of the mouth, today announced that it has been awarded a new  patent in Canada.

The Canadian  Intellectual Property Office granted Canadian Patent No. 2,401,942, a  patent titled "Pharmaceutical Compositions for Buccal and Pulmonary  Application".

This new patent increases the number of issued  patents related to the Company's buccal drug delivery platform  technologies to 161.  A total of 102 patent applications remain pending.

"We  are pleased that we continue to establish the inventiveness of the  Company's buccal delivery system as there has been relatively little  progress over the years in reaching the target of safe and effective  oral formulations for macromolecules, including peptides and proteins",  stated Rose C. Perri, the Company's Chief  Operating Officer.  "We are pleased that we continue to receive patents  from key markets within which our delivery system can be commercialized  with a pipeline of viable applications that will open up other  marketplaces for the Company".  

Quelle: yahoo

Aktueller Kurs: 0,53 US$ (ebd.)

 

 

Eleven new drugs are vying for FDA approval in October...

 

Quelle: www.thestreet.com