Citigroup - Mylan "buy"

of Diovan HCT® Tablets

16:50 21.09.12

PR Newswire

PITTSBURGH, Sept. 21, 2012

PITTSBURGH, Sept. 21, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. This product is the generic version of Novartis' Diovan HCT® Tablets, which are indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.(1)

Mylan CEO Heather Bresch commented: "Mylan's launch of the first generic Valsartan and Hydrochlorothiazide Tablets USP represents our eighth first-to-file launch this year, demonstrating our continued leadership in bringing new generic products to the market. Through this launch, we are proud to continue contributing to the increased health care savings experienced by patients, governments and payors in the U.S. supported by the generic availability of an important, widely prescribed product such as this one."

Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg, had U.S. sales of approximately $1.6 billion for the 12 months ending June 30, 2012, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 168 ANDAs pending FDA approval representing $77.8 billion in annual sales, according to IMS Health. Thirty-three of these pending ANDAs are potential first-to-file opportunities, representing $20.8 billion in annual brand sales, for the 12 months ending June 30, 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 a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third 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 150 countries and territories. Our workforce of more than 18,000 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) Valsartan and Hydrochlorothiazide Tablets can cause injury and death to the developing fetus and therefore should be discontinued if pregnancy occurs. It should also not be used in people who are allergic to any component of the product or to other sulfonamide-derived drugs. Other precautions include: excessive reductions in blood pressure, decreased renal function, allergic reactions, exacerbation or activation of systemic lupus erythematosus, drug interactions with lithium, potassium and electrolyte abnormalities, visual changes and metabolic disturbances. If any of these conditions occur or are suspected, medical attention should be sought.

SOURCE Mylan Inc.
Quelle: PR Newswire  

geht stramm nach oben,ohne Makel das wird heftig heute::+1,13%

:::::Mylan 12 points ;-)  

hier an was ganz Grossem teilhaben zu dürfen ;-)
http://www.ariva.de/news/...fe-Threatening-Allergic-Reactions-4272366  

Star Julie Bowen Joins Mylan Specialty L.P. to Launch Health Awareness Initiative to Address Growing Rate of Life-Threatening Allergic Reactions

13:30 26.09.12

PR Newswire

BASKING RIDGE, N.J., Sept. 26, 2012

BASKING RIDGE, N.J., Sept. 26, 2012 /PRNewswire/ -- Emmy-award winning actress Julie Bowen, known for her comedic role in "Modern Family," is for the first time publicly sharing her family's experience with life-threatening allergies to help drive a national conversation on this serious health issue.  Bowen is partnering with Mylan Specialty L.P. to launch Get Schooled in Anaphylaxis™, a multi-faceted public health initiative that aims to increase awareness of and preparedness for life-threatening allergic reactions (anaphylaxis).

To view the multimedia content, please click: http://www.multivu.com/players/English/...-Allergic-Reactions-4272366  

Mylan Launches Generic Avapro® Tablets and Generic Avalide® Tablets

16:00 28.09.12

PR Newswire

PITTSBURGH, Sept. 28, 2012

PITTSBURGH, Sept. 28, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg, the generic version of Sanofi's Avapro®. The company also received final approval from the FDA for its ANDA for Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5mg and 300/12.5 mg, the generic version of Sanofi's Avalide®. Irbesartan Tablets are indicated for the treatment of hypertension and in patients with type 2 diabetic nephropathy, and Irbesartan and Hydrochlorothiazide Tablets are indicated for hypertension in patients not adequately controlled with a single drug, and as initial therapy in patients likely to need multiple drugs to achieve blood pressure control.(1)

Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg, had U.S. sales of approximately $400.7 million for the 12 months ending June 30, 2012, and Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5mg and 300/12.5 mg, had U.S. sales of approximately $117.4 million, according to IMS Health. Mylan is shipping both products immediately.

Currently, Mylan has 168 ANDAs pending FDA approval representing $79 billion in annual sales, according to IMS Health. Thirty-three of these pending ANDAs are potential first-to-file opportunities, representing $20.7 billion in annual brand sales, for the 12 months ending June 30, 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 a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third 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 150 countries and territories. Our workforce of more than 18,000 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) Irbesartan and Irbesartan and Hydrochlorothiazide Tablets can cause injury and death to the developing fetus and therefore should be discontinued if pregnancy occurs. They should also not be used in people who are allergic to any component of the product or to other sulfonamide-derived drugs. Other precautions for both products include: excessive reductions in blood pressure, decreased renal function, and potassium and electrolyte abnormalities. Reports of exacerbation or activation of systemic lupus erythematosus, drug interactions with lithium, visual changes and metabolic disturbances and impaired liver function have been associated with Irbesartan and Hydrochlorothiazide Tablets. If any of these conditions occur or are suspected, medical attention should be sought.

SOURCE Mylan Inc.
Quelle: PR Newswire  

18,95 € +2,71% +0,50 €
Tradegate, 01.10.12
MfG b.  

ich begleite sie

   Branche Pharmazie
  Herkunft USA
§
buran  

Mylan Schedules Third Quarter 2012 Financial Results Conference Call and Live Webcast

16:55 04.10.12

PR Newswire

PITTSBURGH, Oct. 4, 2012

PITTSBURGH, Oct. 4, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) announced today that it will host a conference call and live webcast on Thursday, Oct. 25, 2012, at 10:30 a.m. ET, to review the company's financial results for the third quarter 2012, which ended Sept. 30, 2012. Mylan will release its financial results on Oct. 25 before the market opens.

The dial-in number to access the call is 877.402.3913 or 817.382.5964 for international callers. A replay, available for approximately seven days, will be available at 800.585.8367 or 404.537.3406 for international callers with access pass code 36921750.

To access a live webcast of the call, please log on to Mylan's Web site (www.mylan.com) at least 15 minutes before the event is to begin to register and download or install any necessary software. A replay of the webcast will be available on www.mylan.com for approximately seven days.

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 a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third 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 150 countries and territories. Our workforce of more than 18,000 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  

Mylan Announces Settlement Agreement for its First-to-File Generic Version of Orapred ODT®

21:45 09.10.12

PR Newswire

PITTSBURGH, Oct. 9, 2012

PITTSBURGH, Oct. 9, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has entered into a settlement agreement with Shionogi Inc. and CIMA Labs Inc. that will resolve patent litigation related to Prednisolone Sodium Phosphate Orally Disintegrating Tablets (ODT), 10 mg, 15 mg and 30 mg. Prednisolone Sodium Phosphate ODT is the generic version of Shionogi's Orapred ODT®, which is indicated for the treatment of certain pulmonary diseases such as asthma. Additionally, the product is indicated for the control of certain severe or incapacitating allergic conditions, such as atopic dermatitis, and seasonal and perennial allergic rhinitis, that are intractable to adequate trials of conventional treatment.

According to the terms of the settlement, Mylan will be licensed to sell its Prednisolone Sodium Phosphate ODT product on April 1, 2014, or earlier under certain circumstances. Pursuant to the agreement, pending litigation will be dismissed. Other details of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Mylan believes it was the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification with the U.S. Food and Drug Administration (FDA) for Prednisolone Sodium Phosphate ODT, 10 mg, 15mg and 30 mg, and anticipates that it will be entitled to 180 days of generic market exclusivity. This product had U.S. sales of $33.1 million for the 12 months ending June 30, 2012, according to IMS Health.

This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of the litigation and sales of the product. 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 introductions; 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 a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third 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 150 countries and territories. Our workforce of more than 18,000 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  

geht voll okay  

http://www.ariva.de/news/...tially-Life-Threatening-Allergies-4300995
buran  

10:16 23.10.12

London (www.aktiencheck.de) - Douglas D. Tsao und Ann Trimble, Analysten von Barclays, stufen die Aktie von Mylan (Mylan Aktie) mit dem Rating "overweight" ein. Das Kursziel werde bei 26 USD gesehen. (Analyse vom 22.10.2012) (23.10.2012/ac/a/a)

Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen.
Quelle: Aktiencheck  

Mylan Files Expedited Motion in Relation to Pioglitazone

20:10 23.10.12

PR Newswire

PITTSBURGH, Oct. 23, 2012

PITTSBURGH, Oct. 23, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has filed an expedited motion in the U.S. District Court for the District of Columbia to stay the Court's order related to Watson's abbreviated new drug application (ANDA) for pioglitazone, pending appeal. The U.S. Food and Drug Administration (FDA) joined Mylan in its motion.    

Mylan CEO Heather Bresch commented, "Mylan is disappointed in yesterday's ruling regarding pioglitazone and we believe the Court erred in its decision by directly contravening the Hatch-Waxman Act. Mylan does not believe Watson is entitled to participate in Mylan's 180-day exclusivity period in relation to this product and we intend to pursue this case vigorously, including seeking expedited relief from the appellate court if necessary."

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 more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third 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 150 countries and territories. Our workforce of more than 18,000 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/...2012-Adjusted-Diluted-EPS-to-0-83-4312563  

http://www.ariva.de/news/...2012-Adjusted-Diluted-EPS-to-0-83-4312563  

Mylan-Aktie: Gewinn legt kräftig zu

17:34 25.10.12

Canonsburg (www.aktiencheck.de) - Der amerikanische Pharmakonzern Mylan Inc. (Mylan Aktie) präsentierte am Donnerstag die Geschäftszahlen für das dritte Quartal.

Demnach lag der Umsatz mit 1,81 Mrd. US-Dollar über dem Vorjahreswert von 1,58 Mrd. US-Dollar im Vorjahreszeitraum. Beim Nettogewinn wurde ein deutlicher Anstieg auf 211,3 Mio. US-Dollar bzw. 51 Cents je Aktie ausgewiesen, nach einem Nettogewinn von 156,7 Mio. US-Dollar bzw. 36 Cents je Aktie im Vorjahreszeitraum. Der um Einmaleffekte bereinigte Gewinn je Aktie lag mit 83 Cents ebenfalls deutlich über dem Vorjahreswert von 55 Cents. Profitiert habe man von einem deutlichen Absatzanstieg in Nordamerika sowie in der Region Asien/Pazifik, so der Pharmakonzern. Analysten hatten zuvor ein EPS von 77 Cents sowie einen Umsatz von 1,85 Mrd. US-Dollar erwartet.

Für das laufende Quartal liegen die Analystenschätzungen bei einem EPS von 64 Cents sowie einem Umsatz von 1,75 Mrd. US-Dollar.

Für das laufende Fiskaljahr erwartet Mylan ein bereinigtes EPS von 2,50 bis 2,60 US-Dollar. Marktbeobachter gehen für das laufende Fiskaljahr von einem EPS von 2,52 US-Dollar aus.

Die Aktie von Mylan notiert derzeit mit einem Plus von 3,88 Prozent bei 24,88 US-Dollar. (25.10.2012/ac/n/a)
Quelle: Aktiencheck  

Perf. seit Threadbeginn:   +241,62% <<<<<< HAMMER  

Canaccord Genuity - Mylan-Aktie: "buy"

14:57 29.10.12

Vancouver (www.aktiencheck.de) - Randall Stanicky und Dana Flanders, Analysten von Canaccord Genuity, stufen die Aktie von Mylan (Mylan Aktie) von "hold" auf "buy" hoch. Das Kursziel werde von 25 auf 30 USD angehoben. (Analyse vom 26.10.2012) (29.10.2012/ac/a/a)

Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen.
Quelle: Aktiencheck  

da schoss der Kurs aber in die Höhe ..ich hau mal den RT rein : 19,75 € mein lieber scholli du ;-))  

...:::es sind alle eingeladen ..für das leibliche Wohl ist gesorgt ;-) buran  

wir jagen die Sau weiter durch die Dorfgassen an den Weltplätzen und HASSAN FASS DIE SAU ulla ulla ulla ;-)))  

Barclays - Mylan-Aktie: Kursziel erhöht

10:18 05.11.12

London (www.aktiencheck.de) - Douglas D. Tsao und Ann Trimble, Analysten von Barclays, stufen die Aktie von Mylan (Mylan Aktie) unverändert mit dem Rating "overweight" ein. Das Kursziel werde von 26 USD auf 28 USD erhöht. (Analyse vom 02.11.2012) (05.11.2012/ac/a/a)

Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen.
Quelle: Aktiencheck  

http://www.ariva.de/news/...ri-Cyclen-Lo-Settlement-Agreement-4334272
buran  

US-amerikanischen Pharmaunternehmen. Kernkompetenz der Gesellschaft ist die Entwicklung, Herstellung und Vermarktung von Generika (Nachahmer-Medikamente, deren Patentschutz abgelaufen ist) und eigenen Marken-Pharmazeutika. Zudem werden aktive pharmazeutische Inhaltsstoffe (API) für die Pharmaindustrie angeboten. Zu den im Produktportfolio befindlichen Generika gehören solche gegen Herz-Kreislauf-Beschwerden (z.B. Clonidine Transdermal System), gegen Diabetes (z.B. Glipizide und Metformin Hydrochloride Tabletten) oder gegen vermindernden Harndrang (z.B. Spironolactone). Hier umfasst das Sortiment des Konzerns derzeit über 140 verschiedene Produkte. Mit seinen Tochtergesellschaften Merck Generics, Mylan Pharmaceuticals und UDL Laboratories werden in fast allen Therapiegebieten kostengünstige Standardtherapien durch qualitativ hochwertige generische Arzneimittel auf den Markt gebracht. Eine besondere Kompetenz hat das Unternehmen zudem bei der Verabreichung von Wirkstoffen über die Haut mittels spezieller Pflaster. Im Bereich der Markenprodukte bietet Mylan vor allem spezielle Aerosole und Injektoren an.  

Datum Erster Hoch Tief Schluss     Stücke Volumen
  09.11.12     25,68     26,24§25,55 25,87 $ 6.408.396 160 M
...Nasdaq