Citigroup - Mylan "buy"

15:00 19.06.13


Das Antidepressivum Citalopram gilt als Kassenschlager. Nach der Markteinführung haben mehrere Pharmafirmen den Preis hochgehalten. Dazu zählte auch Merck aus Darmstadt. Nun müssen die Firmen hohe EU-Bußgelder zahlen.

Der Darmstädter Pharmakonzern Merck muss wegen Preistreiberei ein EU-Bußgeld von 21,4 Millionen Euro zahlen. Nach Ansicht der EU-Kommission hat Merck 2002 mit mehreren anderen Pharmafirmen den Marktstart von billigeren Nachahmerprodukten des Antidepressivums Citalopram in Europa verzögert. Dieses Kartell habe auf Kosten der Patienten den Preis für den Arzneistoff hoch gehalten, sagte EU-Wettbewerbskommissar Joaquín Almunia am Mittwoch in Brüssel. Die Merck KgaA erwägt nach eigenen Angaben, gegen das Bußgeld vor dem Europäischen Gerichtshof zu klagen.

Generika sind billigere Alternativen zu Marken-Medikamenten mit dem gleichen Wirkstoff. Sobald der Patentschutz für ein Präparat abläuft, dürfen Konkurrenten Generika produzieren. Dadurch sinken die Preise, aber eben auch die Gewinne der Marken-Hersteller. Almunia kritisierte die Firmen und sagte: Vereinbarungen dieser Art gehen direkt zulasten der Patienten und schaden den nationalen Gesundheitssystemen. So sei in Großbritannien nach dem Start eines Citalopram-Generikum der Preis um 90 Prozent nach unten gegangen.

Das Kartell startete auf Betreiben des dänischen Konzerns Lundbeck, der Citalopram entwickelte und dann dafür sorgte, dass Generika erst später auf den Markt kamen. Lundbeck muss daher die höchste Strafe von 93,8 Millionen Euro zahlen.

Auf vier Hersteller von Nachahmerprodukten, mit denen Lundbeck die Absprachen getroffen haben soll, entfällt eine Strafe von insgesamt 52,2 Millionen Euro. Dazu gehören die Merck KGaA - mit ihrer ehemaligen britischen Tochter Generics - sowie die europäische Firma Arrow, der US-Anbieter Alpharma und die indische Ranbaxy.Merck prüft Rechtsmittel

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Quelle: Handelsblatt  

und bedient / verbrieft

Zeit  Kurs  Stück  
08:00:01 23,184 ?  300

GRATULATION  

13:35 24.06.13


PR Newswire

PITTSBURGH, June 24, 2013

PITTSBURGH, June 24, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced the appointment of Roger Graham as president of Mylan Specialty. Graham will report to Tony Mauro, president of Mylan North America.

Mylan CEO Heather Bresch commented, "Roger's deep brand pharmaceutical industry experience, entrepreneurial mind-set and goal-oriented leadership make him the ideal candidate to lead Mylan Specialty as we continue to expand this important business. We remain very excited about the growth prospects of the Specialty business and are confident that Roger will bring immediate value to our entire North American organization and help accelerate achievement of our ambitions for Mylan Specialty."

Graham joins Mylan from Advandx, a private developer of in-vitro diagnostic tests in the infectious disease space. He was the company's chief commercial officer and developed its growth strategy for the U.S. and European markets.

Prior to that, Graham spent nearly a decade in executive-level marketing and sales positions at three brand pharmaceutical firms, Auxilium Pharmaceuticals, Adolor Corporation and Yamanouchi Pharma America, where he established, rebuilt and/or expanded U.S. commercial operations.

Earlier, Graham worked at Ortho McNeil, a division of Johnson & Johnson (J&J), where he was vice president of the company's $2 billion anti-infective, analgesia and urology franchise, and its 2,300 primary care and hospital sales and marketing associates. Graham also built Ortho McNeil's $500 million neuroscience and metabolic franchise via the launch and life cycle development of Topamax®.

Graham previously served as director of Marketing for Roche's CNS, pain and dermatology franchises. He began his career with Schering-Plough and, over nearly a decade, took on positions of increasing responsibility in the company's allergy, respiratory and oncology sales and marketing organizations.

Graham has a bachelor's degree in business administration from The University of Kansas and an MBA from Seton Hall University.

This press release includes statements that constitute "forward-looking statements," including with regard to the company's future growth and performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impacts of competition; changes in economic and financial conditions of the company's business; the ability to attract and retain key personnel; uncertainties and matters beyond the control of management; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.


Quelle: PR Newswire  

Generic Micronor® Tablets, 0.35 mg (28-Day Cycle)13:35 26.06.13


PR Newswire

PITTSBURGH, June 26, 2013

PITTSBURGH, June 26, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Norethindrone Tablets USP, 0.35 mg. Norethindrone Tablets USP, 0.35 mg, are the generic version of Janssen Pharmaceuticals, Inc.'s Micronor® Tablets, 0.35 mg (28-Day Cycle), which are indicated for the prevention of pregnancy. Mylan's partner, Famy Care Ltd., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.

Norethindrone Tablets USP, 0.35 mg, had U.S. sales of approximately $57.2 million for the 12 months ending March 31, 2013, according to IMS Health.

Currently, Mylan has 176 ANDAs pending FDA approval representing $83 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.5 billion in annual brand sales, for the 12 months ending December 31, 2012, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.


Quelle: PR Newswire  

http://www.ariva.de/news/...ric-Version-of-Viagra-in-11-Europ-4570432 GrB  

Datum Erster Hoch Tief Schluss     Stücke Volumen
26.06.13 30,45 30,81 30,34  30,48 $ 3.053.229 84,7 M
GrB  

Generikum von Viagra® auf den Markt20:10 26.06.13


PR Newswire

PITTSBURGH und LYON, Frankreich, 26. Juni 2013

PITTSBURGH und LYON, Frankreich, 26. Juni 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL), eines der weltweit führenden Pharmaunternehmen für Generika und Spezialprodukte, hat heute bekannt gegeben, dass es Sildenafil-Zitrat-Tabletten der Dosierungen 25 mg, 50 mg und 100 mg in Frankreich, Großbritannien, Irland, Italien, Belgien, der Slowakei, Deutschland, Dänemark, der Tschechischen Republik, Spanien und den Niederlanden auf den Markt gebracht hat. Mylan hat in jedem dieser Länder durch die jeweiligen Gesundheitsbehörden die Marktzulassung zum sofortigen Vertrieb erhalten. Sildenafil-Zitrat ist die generische Version von Pfizers Viagra®. Dieses Produkt ist für die Behandlung von Erektionsstörungen indiziert.

Viagra® hatte IMS Health zufolge in den zwölf Monaten mit Ende zum 31. März 2013 in Frankreich, Großbritannien, Irland, Italien, Belgien, der Slowakei, Deutschland, Dänemark, der Tschechischen Republik, Spanien und in den Niederlanden einen Gesamtumsatz von 241,1 Millionen Euro (310,4 Millionen US-Dollar).

Mylan ist ein weltweites Pharmaunternehmen, das in der Gesundheitsversorgung neue Standards setzen will. Wir arbeiten zusammen, um den 7 Milliarden Menschen auf der Welt Zugang zu hochwertiger Medizin zu verschaffen; wir betreiben Innovation, um bisher nicht gedeckten Bedarf zu befriedigen; wir erheben Zuverlässigkeit und herausragenden Service zu einer Gewohnheit; tun das Richtige, nicht das Einfache; beeinflussen durch leidenschaftliche Führungskraft die Zukunft der Welt. Wir haben ein wachsendes Portfolio von ca. 1.100 Generika und eine Reihe von Markenpharmazeutika im Angebot. Zudem bieten wir eine Palette antiretroviraler Therapien an, die ca. 40 % der HIV-/AIDS-Patienten in Entwicklungsländern dringend benötigen. Zudem betreiben wir einen der größten Hersteller von pharmazeutischen Wirkstoffen und vertreiben derzeit Produkte in ca. 140 Ländern und Regionen. Unsere mehr als 20.000 Mitarbeiter engagieren sich in verbessertem Service für den Kunden und besserem Zugang zu Pharmazeutika für Verbraucher auf der ganzen Welt. Sie müssen es uns nicht glauben. Sie können es selber sehen. Sehen Sie nach. mylan.com


Quelle: PR Newswire  

of Women's Care Products in India13:35 27.06.13


PR Newswire

MUMBAI, India and PITTSBURGH, June 27, 2013

MUMBAI, India and PITTSBURGH, June 27, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL), one of the world's leading generic and specialty pharmaceutical companies, today announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched a portfolio of Women's Care products in India. The portfolio, which initially will consist of eight products, focuses on therapies such as hormones, pre- and post-natal nutrition and management of premenstrual syndrome (PMS). This launch builds on Mylan's launch of a comprehensive portfolio of antiretroviral products in India last year.

Mylan CEO Heather Bresch commented, "The launch of Mylan's Women's Care portfolio expands and strengthens our growing commercial platform in India and further delivers on our commitment to provide the world's population with access to high quality medicine. Women's Care represents a high-growth therapeutic category in India and an opportunity for Mylan to help satisfy unmet medical needs. More than 85% of women of childbearing age in India suffer from PMS1, approximately one in five pregnancies in Indian women end in miscarriage2, and it is estimated that the number of infertile couples in India is around 12 million3."

Bresch continued, "A key challenge in Women's Health continues to be how to address the risks of miscarriages, infertility and nutritional deficiencies. In addition to launching our innovative, high quality product portfolio, Mylan will help to strengthen the capabilities of health care providers in this area through training programs and workshops, working together with the medical community to address areas of concern in women's health and improve timely access to appropriate high quality treatment."

Mylan President Rajiv Malik said, "With the addition of the Women's Care portfolio, Mylan's commercial platform is increasingly well-positioned to serve the fast growing Indian market. We expect to continue to expand into new therapeutic categories, further expand our field force and leverage our strong distribution capabilities in India to support future product launches."  

This press release includes statements that constitute "forward-looking statements," including with regard to the company's growth potential and expansion of its operations. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impact of competition; the effect of any changes in customer and supplier relationships; the ability to attract and retain key personnel; changes in economic and financial conditions of the Company's business; uncertainties and matters beyond the control of management; and the other risks detailed in the company's periodic filings with the U.S. Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

[1] Source: Indian Journal of Clinical Practice, Vol. 22, March 2012

[2] DC Duta textbook of Obstetrics

[3] Source: United Nations Population Fund Information Booklet on Prevention and Management of Infertility in Primary Healthcare Settings

SOURCE Mylan Inc.


Quelle: PR Newswire  

30,90 $ +1,38% +0,42 $ , 27.06.13 , GrB  

for National HIV Testing Day14:05 27.06.13


PR Newswire

PITTSBURGH, June 27, 2013

PITTSBURGH, June 27, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL), today expresses its support for National HIV Testing Day, an annual campaign to encourage people of all ages to be proactive and know their HIV status. According to the Centers for Disease Control and Prevention (CDC), more than 1.1 million people in the U.S. are living with HIV and 1 in 5 does not know they are infected. Getting tested is the first step in taking control of your health.

CEO Heather Bresch commented, "About half of all new HIV infections in the U.S. are attributed to the 20% of HIV-positive individuals who do not know they are infected. Knowing your status is a powerful step toward lowering the rate of HIV infections and ultimately eliminating the disease altogether."

There are 50,000 new cases of HIV infection every year in the U.S., according to the CDC, and over half of these infections occur in people ages 12 to 34. Recent studies have shown that HIV-positive people who are on antiretroviral medications (ARVs) can expect to live a long and healthy life with no increased risk of mortality, and are 96% less likely to transmit the virus to others.

Bresch continued, "The U.S. Department of Health and Human Services guidelines state that all people living with HIV in the U.S. are eligible for life-saving ARVs regardless of their disease progression. Mylan is dedicated to helping those infected with HIV live life to its fullest potential by providing access to more affordable versions of these medications."

Knowledge is power in the fight against HIV/AIDS. To find a testing site near you, visit hivtest.cdc.gov or text your zip code to KNOWIT (566948).

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.


Quelle: PR Newswire  

Agreement for Innovative Point-of-Care CD4 Diagnostic Test, Enhancing Mylan's Leadership Position in HIV Care07:05 30.06.13


PR Newswire

PITTSBURGH and FREMONT, Calif., June 30, 2013

PITTSBURGH and FREMONT, Calif., June 30, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has entered into an exclusive agreement with Zyomyx, Inc. for the rights to distribute Zyomyx's proprietary point-of-care (POC) CD4 T-cell count test in the developing world. CD4 count testing is a critical diagnostic component in treating HIV/AIDS, as medical professionals refer to a patient's CD4 count to determine when to begin and/or alter HIV treatment. As part of the agreement, Mylan also has made a strategic equity investment in Zyomyx.  

The Zyomyx POC CD4 test is currently in final stages of development and expected to launch in the near-term, pending applicable regulatory approvals. Mylan expects to distribute the portable, easy-to-use, low-cost test in the developing world alongside its broad portfolio of high quality, affordable generic antiretroviral (ARV) drugs in order to improve access to and guide HIV/AIDS treatment in resource-limited settings.

To complement the exclusive agreement with Zyomyx, Mylan also announced that it has signed a Global Access Commitment with the Bill & Melinda Gates Foundation, an investor in Zyomyx. Mylan has committed to ensuring that the Zyomyx POC CD4 technology can be made available and accessible at a reasonable price in high burden HIV countries.  Increasing access to affordable and effective health interventions for those in need is a priority for the foundation.

Mylan CEO Heather Bresch commented, "Mylan's mission is to set new standards in health care and provide the world's 7 billion people access to high quality medicine. We expect that this distribution agreement with Zyomyx and our collaboration with the Bill & Melinda Gates Foundation will be a true game changer in improving access to treatment of HIV in the developing world by enabling rapid, low-cost testing of patients in any location, however remote, thereby ensuring immediate enrollment on treatment. Further, this distribution agreement and investment represents Mylan's entry into diagnostics as we strive to meet the evolving needs of our customers and patients. It will transform Mylan from a leading provider of HIV treatments to a leading provider of HIV health care solutions, which will continue to differentiate Mylan in this important area."

Rajiv Malik, Mylan's president, added, "Zyomyx's CD4 test is a revolutionary technology that couldn't come at a better time. The World Health Organization's revised antiretroviral treatment guidelines increase the number of people living with HIV and eligible for treatment to close to 26 million, and pregnant women are now advised to start treatment as soon as they test positive. The more quickly patients can receive CD4 testing, the more quickly they can access life-saving medicine. Mylan's investment in Zyomyx is just one step in our efforts to support the goal of universal access to HIV/AIDS treatment."

Trevor Mundel, president of Global Health at the Bill & Melinda Gates Foundation, said, "HIV patients in the developing world have long faced considerable challenges accessing CD4 testing due to the poor availability of testing in rural areas, the challenges of travel to testing sites and the cost of the tests. Mylan's investment in Zyomyx and collaboration with the foundation will potentially greatly enhance access to testing and treatment in the developing world."

The Zyomyx CD4 count test, the first product developed using Zyomyx's breakthrough diagnostic platform, is easy-to-use and the fastest yet, providing results in less than 10 minutes with minimal training. The test is portable and disposable – small enough to fit into a back-pack and requiring no grounded electricity  – making it ideal for use in developing markets and rural settings. Importantly, the test is highly accurate and has proven to be equivalent in accuracy to flow cytometry, the current gold standard in CD4 count testing.

Peter Wagner, president and CEO of Zyomyx, said, "As a diagnostics company, we are excited about the potential impact of this agreement with Mylan, a pharmaceutical company that has access to nearly every HIV/AIDS treatment clinic in Africa through its impressive distribution network. Together, we will be able to ensure that people living with HIV/AIDS in the highest burden countries receive both the testing and lifesaving treatment they need."

Mylan has been a leading global player in the HIV/AIDS arena for more than a decade and a leader in bringing to market innovations that enhance access to treatment, for instance producing fixed dose combinations, which provide a reduced pill burden and once-a-day dosage, and patient-convenient "combo" packs. Mylan also developed multiple FDA/WHO-approved heat-stable ARV products, which can be distributed and used in warm climates where refrigeration infrastructure is not widely available. In addition, Mylan has been a global leader in producing ARV formulations for pediatric use. Today, Mylan supplies high quality ARVs to more than 120 countries around the world and nearly 40% of HIV/AIDS patients receiving treatment in developing countries depend on one of the company's ARV products.

Under the terms of the distribution and supply agreement, Zyomyx will supply the POC CD4 test to Mylan, and Mylan will pay development and commercial milestones and a share of profits to Zyomyx for the exclusive rights to distribute the POC CD4 test in Africa; Asia (excluding Japan and South Korea but including (without limitation) Russia, Central Asia and the Middle East); CEE; CIS; South America and Central America (including Mexico); and the Caribbean Islands. Further, simultaneous with the execution of the distribution and supply agreement, Mylan made a strategic equity investment in Zyomyx and entered into an agreement with the Bill & Melinda Gates Foundation to provide improved and affordable CD4 testing access to patients in high burden HIV countries. All other terms of the agreements are confidential.

This press release includes statements that constitute "forward-looking statements," including with regard to the distribution and supply agreement. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impact of competition; failure to achieve anticipated sales; changes in economic and financial conditions of the company's business; uncertainties and matters beyond the control of management; and the other risks detailed in the company's periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

About Zyomyx

Zyomyx, Inc., a privately held diagnostics company based in Fremont, California, is an innovator  in the development and commercialization of proprietary diagnostic platforms. The Zyomyx product development infrastructure and suite of proprietary assay and surface technologies are ideally suited for the development of affordable, disposable point-of-care diagnostic products, designed to increase access to testing.  Zyomyx's immediate focus is an advanced but simple and inexpensive CD4 T-cell point-of-care test that will be launched globally and is configured to meet the needs of developing countries.  For more information, visit http://www.zyomyx.com.

About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.


Quelle: PR Newswire  

Datum Erster Hoch Tief Schluss     Stücke Volumen
03.07.13 30,18 30,57 30,01  30,47 $ 1.538.542 46,6 M
GrB  

in Favor of Mylan in Patent Infringement Litigation Against Sunovion's Brovana® Product15:50 08.07.13


PR Newswire

PITTSBURGH, July 8, 2013

PITTSBURGH, July 8, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that the U.S. District Court for the Southern District of New York has issued a Final Judgment and Order following a ruling by the Court of Appeals for the Federal Circuit in favor of Mylan Specialty L.P., f/k/a Dey Pharma, L.P. The Order states that five of Mylan's patents related to its Perforomist® Inhalation Solution are valid and enforceable. Further, the Order states that Sunovion's Brovana® product infringes each of those patents.

Mylan previously announced a settlement agreement with Sunovion resolving the litigation relating to Sunovion's Brovana® product. In May 2012, the U.S. District Court for the Southern District of New York issued a Final Judgment and Order stating that Sunovion has acknowledged that two Mylan patents related to its Perforomist® Inhalation Solution are valid, enforceable and infringed by Sunovion's Brovana® product.

As a result of the two Court Orders, all seven Mylan patents relating to Perforomist® have been upheld as valid and enforceable and infringed by Sunovion's Brovana® product.

Mylan CEO Heather Bresch commented, "We have always believed in the strength and validity of the intellectual property protecting Perforomist, as well as our combination product for the treatment of Chronic Obstructive Pulmonary Disease (COPD), currently in development. We are pleased to have prevailed in the appellate court and settled this litigation and that the Court's Order brings this matter to a close."

This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of the litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product sales; risks inherent in legal and regulatory processes; and the other risks detailed in the company's periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.


Quelle: PR Newswire  

http://www.ariva.de/news/...2013-Adjusted-Diluted-EPS-to-0-68-4735443 GrB  

- Umsatz leidet unter Währungseinflüssen22:23 01.08.13

PITTSBURGH (dpa-AFX) - Der Stada-Konkurrent Mylan hat im zweiten Quartal mehr verdient und umgesetzt als im entsprechenden Vorjahresviertel. Der bereinigte Gewinn je Aktie (EPS) sei um 13 Prozent auf 68 Cent geklettert, teilte der US-Generikahersteller am Donnerstag mit. Experten hatten mit einem Cent weniger gerechnet. Der um Währungseinflüsse und die Produkteinführung von Escitalopram bereinigte Umsatz legte um 10 Prozent auf 1,70 Milliarden US-Dollar zu. Hier hatten Analysten mit 1,73 Milliarden Dollar ein wenig mehr erwartet. Ohne die Einflüsse hätte das Plus lediglich bei 1 Prozent gelegen.

Im laufenden Jahr will Mylan weiter ein EPS von 2,75 bis 2,95 Dollar erzielen. Beim Umsatz rechnet Finanzvorstand John Sheehan wegen Währungseinflüssen nur noch mit einem Erreichen der unteren Spanne der ursprünglichen Prognose von 7,0 bis 7,4 Milliarden Dollar.

2014 soll das EPS dann auf 3,39 Dollar steigen, wie Mylan-Chefin Heather Bresch laut Mitteilung andeutete. Der Umsatz soll demnach im kommenden Jahr im Vergleich zu 2013 um 12 Prozent zulegen. An der Wall Street gingen Mylan-Papiere mit einem Aufschlag von 1,25 Prozent aus dem Handel./he

Quelle: dpa-AFX  

36,98 so die nächste Abfahrt / ask / RT

2.037.031 Stücke bereits unter die Tickertafel gefeuert HAMMER  

Free EpiPen® (epinephrine) Auto-Injectors to U.S. Schools13:05 14.08.13


PR Newswire

BASKING RIDGE, N.J., Aug. 14, 2013

BASKING RIDGE, N.J., Aug. 14, 2013 /PRNewswire/ -- Mylan Specialty L.P., the fully integrated specialty pharmaceutical business of Mylan Inc. (NASDAQ: MYL), today announced it is continuing the EpiPen4Schools™ program. In its first year, more than 20,000 schools across all 50 states participated in the program that offers four free EpiPen or EpiPen Jr® (epinephrine) Auto-Injectors to qualifying schools in the U.S. Qualifications include having a valid prescription.

Over the last year, there has been significant legislative movement across the country to improve access to epinephrine, which should encourage more schools to take advantage of the EpiPen4Schools program. The goal of the program is to help schools have ready access to epinephrine auto-injectors in case a person experiences a life-threatening allergic reaction (anaphylaxis) at school. People are encouraged to visit www.EpiPen4Schools.com for more information.

"Educating the public about anaphylaxis preparedness and working to improve access to treatment continues to be an important focus at Mylan, which is why we are pleased to be able to extend EpiPen4Schools," said Heather Bresch, CEO of Mylan. "We hope all schools that have participated in the past will sign up again, and those that haven't yet enrolled in the EpiPen4Schools program will do so quickly, so that EpiPen Auto-Injectors are in place by the start of the 2013 school year."

Anaphylaxis is unpredictable. For those at risk, it is important to be prepared with an anaphylaxis action plan that includes avoiding known allergens, recognizing the signs and symptoms of anaphylaxis, having immediate access to two epinephrine auto-injectors and seeking immediate emergency medical care should anaphylaxis occur. However, accidental exposure to an allergen can still occur and first-time reactions to unknown allergens are a possibility. Schools should also be prepared with an anaphylaxis action plan.

"Anaphylaxis is life-threatening and can occur quickly, without warning," said Ruchi Gupta, M.D., M.P.H., Associate Professor of Pediatrics at Northwestern University and Lurie Children's Hospital. "In the last year, we've seen more than 20 cases of anaphylaxis in Chicago Public Schools (CPS) and have felt the positive impact of being prepared with an anaphylaxis action plan and having immediate access to epinephrine – made possible through the EpiPen4Schools program."

The back-to-school season is a key time for people affected by severe allergies to take important steps to start the school year off right. Dr. Gupta offers the following back-to-school checklist to help parents, caregivers and schools be better prepared for anaphylaxis this school year:

For Parents/Caregivers

Mark your calendar. Meet with a health care provider and make sure your child's anaphylaxis action plan is up to date.
Stay timely. Check expiration dates on your child's epinephrine auto-injectors, and request new prescriptions if needed. Mylan Specialty offers patients the opportunity to register their EpiPen Auto-Injectors at MyEpiPen.com to receive expiration reminders.
Take two. Make sure your child always has immediate access to two epinephrine auto-injectors, as prescribed by a health care provider.
Be vocal. Communicate with your child's school often to ensure planned school activities accommodate your child's needs.
For Schools/School Nurses

Get educated. Make sure school staff members are aware of which students are at risk, know the signs and symptoms of anaphylaxis and are trained how to respond if anaphylaxis occurs.
Have a plan. Make sure the school has an anaphylaxis action plan that includes the following elements for people at risk and those who may experience anaphylaxis for the first time at school:
Avoid known allergens
Recognize signs and symptoms
Have access to two epinephrine auto-injectors
Seek immediate emergency medical care should anaphylaxis occur
Get in the know. See if your school qualifies to participate in the EpiPen4Schools program by visiting www.EpiPen4Schools.com.
Be inclusive. Make sure all classroom activities are appropriate for every student.
In addition to avoiding allergic triggers and recognizing signs and symptoms, people at risk for anaphylaxis should have access to two epinephrine auto-injectors at all times, and school personnel should be trained on how to administer epinephrine and seek immediate emergency medical care should anaphylaxis occur.

For more information on anaphylaxis, life-threatening allergies and EpiPen Auto-Injector, visit www.25YearsofEpiPen.com  

Indications

EpiPen® (epinephrine) 0.3 mg and EpiPen Jr® (epinephrine) 0.15 mg Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen and EpiPen Jr are intended for immediate self administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use.

Important Safety Information

EpiPen Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. DO NOT INJECT INTO YOUR VEIN, BUTTOCK, FINGERS, TOES, HANDS OR FEET. In case of accidental injection, please seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Tell your doctor if you have certain medical conditions such as asthma, depression, thyroid disease, Parkinson's disease, diabetes, high blood pressure and heart disease, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your doctor all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you take the EpiPen or EpiPen Jr Auto-Injector.

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness or anxiety. These side effects usually go away quickly, especially if you rest.

Talk to your healthcare professional to see if EpiPen or EpiPen Jr Auto-Injector is right for you.

Please click here or visit www.EpiPen.com for the EpiPen Auto-Injector full Prescribing Information.

Please click here or visit www.EpiPen.com for the EpiPen Auto-Injector Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

About Anaphylaxis

Anaphylaxis is a life-threatening allergic reaction that has many possible triggers, occurs quickly, without warning, and must be treated immediately with epinephrine. Symptoms may include hives or redness of the skin, tightness in the throat, nausea, dizziness, breathing problems, a decrease in blood pressure and/or fainting. Anaphylaxis can be caused by triggers such as food, stinging and biting insects, medicines, latex or even exercise. Epinephrine is the only first-line treatment for anaphylaxis. According to the food allergy guidelines developed by the National Institute of Allergy and Infectious Diseases, if experiencing anaphylaxis, a person should use an epinephrine auto-injector and seek immediate emergency medical attention. Carrying an epinephrine auto-injector does not prevent patients from having an anaphylactic reaction; hence, patients must avoid their allergic triggers at all times.  Epinephrine is a naturally-occurring hormone, also known as adrenaline, and it should be available at all times to patients at risk. Delays in epinephrine administration have been associated with negative health consequences, even possibly death.

About the EpiPen4Schools Program

The EpiPen4Schools program was launched in August 2012 to help improve access to epinephrine in the event a person experiences anaphylaxis in the school setting. The program will continue to offer four free EpiPen or EpiPen Jr Auto-Injectors, upon qualification, which includes having a valid prescription, to public and private kindergarten, elementary, middle and high schools in the U.S. The products are available in the form of two EpiPen 2-Pak® cartons, two EpiPen Jr 2-Pak® cartons or one 2-Pak of each kind. EpiPen Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. EpiPen and EpiPen Jr are intended for immediate self administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use. For complete program details, visit www.EpiPen4Schools.com.

To participate in EpiPen4Schools, a school nurse or other authorized school representative must visit www.EpiPen4Schools.com to download the order and certification form, then fax or email the form with a valid prescription to 1-973-718-4328 or info@bioridgepharma.com. Alternately, school representatives can call 1-973-845-7600 to speak with a live representative.

In addition to the EpiPen4Schools program, Mylan Specialty offers a discount program through which schools can purchase, upon qualification, EpiPen 2-Pak cartons and EpiPen Jr 2-Pak cartons at a discounted price. There is no requirement for a school to purchase additional EpiPen Auto-Injectors or any other Mylan Specialty products.

About EpiPen® Auto-Injector

EpiPen Auto-Injectors are used for the emergency treatment of life-threatening allergic reactions. Each EpiPen 2-Pak contains two single auto-injectors, instructions for use and a training device, with no drug product or needle, to help patients become familiar with the administration technique. EpiPen Auto-Injector should be administered immediately at the first sign of an anaphylactic reaction. EpiPen Auto-Injector is not a substitute for emergency medical treatment. Patients should seek emergency medical attention immediately following administration. For more information about EpiPen Auto-Injector, please visit www.epipen.com.

About Mylan Specialty

Mylan Specialty, a subsidiary of Mylan Inc. (NASDAQ: MYL), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, life-threatening allergic reactions and psychiatric disorders. For more information, please visit www.mylanspecialty.com.

About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

EpiPen®, EpiPen Jr®, EpiPen 2-Pak® and EpiPen Jr 2-Pak® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned subsidiary, Mylan Specialty L.P.

EpiPen4Schools™ is a trademark of Mylan Inc.

© 2013 Mylan Specialty L.P. All rights reserved.

EPI-2013-0277

SOURCE Mylan Inc.


Quelle: PR Newswire  

14er Satz

Datum Erster Hoch Tief Schluss     Stücke Volumen
14.08.13 37,21 37,25 36,61  36,82 $ 3.991.253 141 M

GrB  

in Stuttgart eingekauft

Zeit  Kurs  Stück  
08:02:20 27,145 ?  100
___________________
GRATULATION and welcome ..buran  

of sANDA for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg19:05 22.08.13


PR Newswire

PITTSBURGH, Aug. 22, 2013

PITTSBURGH, Aug. 22, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that the company has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) providing bioequivalence study results requested by FDA for Bupropion Hydrochloride (HCl) Extended-release (ER) Tablets USP (XL), 300 mg. Bupropion HCl ER Tablets USP (XL) are the generic version of WELLBUTRIN XL® and are indicated for the treatment of major depressive disorder (MDD).(1) Mylan launched its Bupropion HCl ER Tablets USP (XL), 150 mg and 300 mg, to the U.S. market in September 2010.

In a correspondence issued December 2012, FDA requested all generic drug companies marketing a version of Bupropion HCl ER Tablets, 300 mg, to conduct a fasting bioequivalence (BE) study comparing their Bupropion HCl ER tablets, 300 mg, to GSK's WELLBUTRIN XL (Bupropion Hydrochloride Extended-release) Tablets, 300 mg. In April 2013, Mylan submitted to FDA a sANDA containing the requested study, which demonstrated bioequivalence of Mylan's Bupropion HCl ER Tablets USP (XL), 300 mg, to WELLBUTRIN XL(R) Tablets, 300 mg.

For the 12 months ending June 30, 2013, Bupropion Hydrochloride Extended-release Tablets, 150 mg and 300 mg, had U.S. sales of approximately $503.3 million, according to IMS Health.

Currently, Mylan has 179 ANDAs pending FDA approval representing $84 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $23.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

(1) Patients with a seizure disorder and pediatric patients should not take Bupropion.  Antidepressant medications have been shown to increase the risk of suicide, compared to placebo, in children, adolescents and young adults. Bupropion HCl ER Tablets USP (XL) should not be used for smoking cessation.

SOURCE Mylan Inc.


Quelle: PR Newswire  

Datum Erster Hoch Tief Schluss     Stücke Volumen
30.08.13 35,37 35,45 35,05  35,34 $ 3.044.376 101 M

......supi  

Zeit  Kurs  Stück  
11:48:26 26,531 ?  15
__________________
hübsche KO und GRATULATION

hier noch mal fix:: RTK 26,531 ? ..und hier du >>> Pott +264,44% ..ulla ulla oleeeee ..watt iss unsere Mylan doch schei  

from India's Foreign Investment Promotion Board and Cabinet Committee on Economic Affairs18:05 03.09.13


PR Newswire

PITTSBURGH, Sept. 3, 2013

PITTSBURGH, Sept. 3, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its proposed acquisition of the Agila injectables businesses from Strides Arcolab Limited (BSE: 532531, NSE: STAR) has received approval from India's Foreign Investment Promotion Board (FIPB). Subsequently, the transaction also received approval from the Cabinet Committee on Economic Affairs (CCEA). The transaction is expected to close in the fourth quarter of 2013, subject to remaining regulatory approvals and certain closing conditions.

Mylan CEO Heather Bresch commented, "We are very pleased to have received all outstanding Indian pre-merger regulatory approvals for the Agila transaction, especially considering the increased government regulation and oversight with respect to foreign investment in India.  We look forward to completing the acquisition in the coming months, which we believe will establish Mylan as a global injectables leader, with a significantly expanded and strengthened injectables portfolio, pipeline, platform and capabilities."

This press release includes statements that constitute "forward-looking statements," including with regard to the consummation of the planned transaction and Mylan's expected future performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: factors relating to satisfaction of the conditions to the consummation of the transaction, including remaining regulatory approvals; the impact and effects of legal or regulatory proceedings, actions or changes; general market perception of the transaction; uncertainties and matters beyond the control of management; the ability of the company to achieve the synergies or other benefits anticipated as a result of the acquisition; any conditions imposed upon the company in connection with obtaining regulatory approvals; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.


Quelle: PR Newswire  

nächste Abfahrt:: Preis 35,75 $ Schleife 100 spread 0,03% ..buran und tau  

of Transdermal Patch Facility Expansion Project in St. Albans, Vt.17:05 04.09.13


PR Newswire

ST. ALBANS, Vt., Sept. 4, 2013

ST. ALBANS, Vt., Sept. 4, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced the completion of an 85,000 square foot, three-story expansion project at its transdermal patch facility, operated by Mylan Technologies Inc. (MTI), in St. Albans, Vt. Through Mylan's investment, including funding for expanded research and development (R&D) capabilities and additional manufacturing and laboratory space, the company is in the process of adding more than 160 new positions to its St. Albans-based workforce. MTI is a proven leader in transdermal drug delivery systems – patches that deliver medication through the skin – and related technologies.

In conjunction with the expansion project, Mylan today hosted a ribbon-cutting ceremony to commemorate the occasion. Vermont Governor Peter Shumlin as well as a number of local officials, community members and employees, attended the event.





Mylan CEO Heather Bresch said: "Mylan's investment in the ongoing growth of our transdermal franchise demonstrates our continued commitment to and confidence in our ability to provide complex generic and interchangeable products and innovative delivery alternatives, such as transdermals. Through this expansion, MTI will continue to play a critical role in the expansion and diversification of Mylan's global product portfolio, especially when it comes to difficult-to-develop and –manufacture products. I would like to thank Governor Shumlin as well as the city of St. Albans for their ongoing support of this project. Importantly, I would also like to recognize Mylan's more than 590 employees in Vermont for their hard work and dedication to our continued success."





The 14-month expansion project has increased MTI's total operating space to more than 391,000 square feet. Since becoming a part of the Mylan manufacturing network more than 20 years ago, MTI has developed a number of branded and generic transdermal products available to patients in markets around the world, including the U.S., Canada, Europe, Japan, New Zealand and Australia.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.


Quelle: PR Newswire