Citigroup - Mylan "buy"

Datum Erster Hoch Tief Schluss     Stücke Volumen
  09.01.14     44,83     45,28§44,445 45,10 $ 3.060.521 129 M

GrB  

Global Collaboration and Strategic Operations
19:35 08.01.14

PR Newswire

PITTSBURGH, Jan. 8, 2014

PITTSBURGH, Jan. 8, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced the appointment of Adele Gulfo as executive vice president, Global Collaboration and Strategic Operations. Gulfo will serve as a member of Mylan's executive leadership team.

Prior to joining Mylan, Gulfo served as regional president of Latin America in Pfizer's Emerging Markets Business Unit. In this capacity, she led a team of over 4,000 colleagues operating across more than 23 countries. In 2012, under her leadership, the Latin American business achieved more than $3 billion in revenue, making it the largest revenue generator within the Business Unit. Previously, Gulfo served as president and general manager of Pfizer's U.S. Primary Care Business Unit, which included the Managed Markets (Corporate and Government Customer) organization for all of Pfizer's Biopharmaceutical Business Units. In 2011, Pfizer's U.S. Primary Care business generated $13 billion in revenue under her leadership. Earlier in her career at Pfizer, Gulfo was instrumental in the launch of LIPITOR®, which became the world's most successful medicine in terms of sales, and was recognized for developing medical and public education campaigns that helped to establish the significance of lowering cholesterol in preventing and managing heart disease.

Mylan CEO Heather Bresch commented, "Adele's rich and diverse experience in the pharmaceutical industry will bring significant strategic value and leadership to Mylan in numerous areas. For instance, we believe Adele's expertise will support many of our key growth drivers, including our expansion in Latin America, the development and expansion of our global Specialty franchise, and the development of global commercial strategies to maximize our key upcoming launches of increasingly complex generic products, such as in the biologics and respiratory areas. Further, Adele has proven her ability to drive collaboration across and among large, complex organizations in order to leverage capabilities and best practices to drive revenue, and we believe she can support our continued efforts to differentiate Mylan's comprehensive commercial offering to our customers."

Gulfo said, "I had the privilege of collaborating with Mylan during my time at Pfizer, and I am energized both by Mylan's mission to provide high quality medicine to the world's population and by the significant opportunities for growth I see ahead for the company. Mylan brings customers and patients a unique value proposition in terms of its broad product portfolio, vertically-integrated high quality manufacturing platform and expansive global commercial reach. The company's initiatives to leverage these strengths and build on them, for instance through the addition of differentiated products and enhanced services, will further distinguish Mylan from its peers. I look forward to utilizing my expertise and relationships to help execute on this strategy and support Mylan's transformation from a pharmaceutical company into a health care company."

Prior to joining Pfizer, Gulfo was vice president of Business Development, Innovation and Design for Launch at Astra-Zeneca Pharmaceuticals. In her nine years with the company, she led the multi-billion dollar cardiovascular business, including marketed and emerging products. Among other achievements, she grew Toprol-XL® sales from $200 million to $2 billion and launched cholesterol-lowering medicine Crestor® with a significantly differentiated life-cycle development program, growing it to a more than $2 billion product in 2009.

Gulfo has been awarded five U.S. patents for innovative packaging designed to help patients adhere to their medicines. She holds a bachelor's degree in Biology from Seton Hall University and a MBA from Fairleigh Dickinson University. She also studied post-graduate microbiology and began her career at the University of Medicine and Dentistry of New Jersey.

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 more than 1,300 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  

Mylan Launches Generic Myfortic® Delayed-Release Tablets
13:00 09.01.14

PR Newswire

PITTSBURGH, Jan. 9, 2014

PITTSBURGH, Jan. 9, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic® Delayed-release Tablets. Mylan was the first company to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for Mycophenolic Acid Delayed-release Tablets, 360 mg, and was awarded 180 days of marketing exclusivity for this strength. The company received final approval from the U.S. Food and Drug Administration (FDA) for its ANDA for this product.

Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg, had U.S. sales of approximately $306.8 million for the 12 months ending Sept. 30, 2013, according to IMS Health. Mycophenolic Acid Delayed-release Tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.(1)

Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $24 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.

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 1,300 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) Use during pregnancy is associated with increased risk of birth defects. Women of child bearing age must be counseled regarding pregnancy prevention. Use of mycophenolic acid delayed release tablets is associated with suppression of the immune system and can increase the risk of lymphoma and other malignancies, particularly of the skin.  There is also an increased risk of bacterial, viral, fungal, and protozoal infections.

SOURCE Mylan Inc.


Quelle: PR Newswire  

Datum Erster Hoch Tief Schluss     Stücke Volumen
  09.01.14     44,83     45,28§44,445 45,10 $ 3.060.521 129 M

GrB  

Zeit    Kurs Stück
  10:45:19§33,398 € 304
  09:20:55§32,889 € 300
_________________
GRATULATION  

CE Mark for MyT4™ Point-of-Care CD4 Diagnostic Test
13:35 09.01.14

PR Newswire

PITTSBURGH, Jan. 9, 2014

PITTSBURGH, Jan. 9, 2014 /PRNewswire/ -- Mylan, Inc. (Nasdaq: MYL) today announced that Zyomyx's MyT4™ point-of-care CD4 diagnostic test has received the CE Certificate of Conformity in the European Union, an important step toward launching this innovative test and expanding access to affordable, accessible and reliable diagnostics for people living with HIV globally. As a result, the MyT4™ CD4 test can now bear the CE Mark, which demonstrates that the MyT4™ CD4 test complies with stringent requirements related to the quality, safety, and performance of in vitro medical devices found in the applicable EU laws. Mylan and Zyomyx, the manufacturer of MyT4™, announced in July 2013 their exclusive distribution agreement for the test in developing countries.

Mylan CEO Heather Bresch commented, "Mylan is proud to continue its commitment to setting new standards in health care by collaborating with Zyomyx on their MyT4™ test. The CE Mark for the MyT4™ test testifies to the exacting quality, safety and performance of this important diagnostic tool and we look forward to begin distributing it in the coming months."

According to the Joint United Nations Programme on HIV/AIDS, more than 28 million people living with HIV are in need of antiretroviral therapy treatment. Measuring a person's CD4 count provides an indication of the virus' impact on their immune system, and is a critical tool in staging and monitoring HIV patients. Significant barriers to routine CD4 measurement exist in developing countries, primarily because diagnostic equipment is available only in centralized laboratory facilities. The durable construction and rapid time-to-result of the MyT4™ test allow for its use in decentralized settings, such as rural communities, mitigating barriers posed by the limited availability of existing diagnostic devices.

This press release includes statements that constitute "forward-looking statements," including with regard to regulatory matters. 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 and effects of legal or regulatory proceedings; 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 more than 1,300 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  

EK 45,46 last shares 100 full realtime 790.533 peak 45,75 buran und MfG und danke und weitermachen und VÖLLAAAAAAAA ÄT JIBT NUR EIN RUDI VÖLLAAAAAAAAA  

Datum Erster Hoch Tief Schluss     Stücke Volumen
  22.01.14     46,62     46,73§45,87 45,91 $ 2.468.439 104 M

GrB  

Datum Erster Hoch Tief Schluss     Stücke Volumen
  22.01.14    34,056    34,056§34,056 34,056 € 70 2.384

GrB  

Datum Erster Hoch Tief Schluss     Stücke Volumen
  22.01.14    34,469    34,469§34,00 34,00 € 510 17.434

GrB  

Cablevision, GNC Holdings, and Mylan Labs Released By InvestorsObserver
15:35 22.01.14

PR Newswire

CHICAGO, Jan. 22, 2014

CHICAGO, Jan. 22, 2014 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ADBE, FL, CVC, GNC, and MYL.

To see what our analysts have discovered about these stocks read the InvestorsObserver's PriceWatch Alerts at http://www.investorsobserver.com/pr/12120142 (Note: You may have to copy this link into your browser then press the [ENTER] key.)

Today's PriceWatch Alerts cover the following stocks: Adobe (Nasdaq: ADBE), Foot Locker (NYSE: FL), Cablevision (NYSE: CVC), GNC Holdings (NYSE: GNC), and Mylan Labs (Nasdaq: MYL).




InvestorsObserver's PriceWatch Alerts contain concise, detailed strategies for each stock we cover, including position protection tactics designed to defend investors from potential market shifts. While many other market reports only provide stock news and opinion, we offer strategies that can bulwark investments against uncertainty and increase chances of making a profit, even if a stock goes down.

"We go above and beyond typical market coverage," said Bobby Raines, Analyst at InvestorsObserver. "Trading experts and beginning investors alike can find value in our PriceWatch Alerts. We provide actionable strategies that protect investments with basic hedging tactics, along with a concise explanation of our techniques."

For essential information on stocks poised to move go to:

http://www.investorsobserver.com/pr/12120142 for InvestorsObserver's PriceWatch Alerts.

InvestorsObserver.com is an online newsletter which focuses on the U.S. equities and options markets. Our analytical tools, screening techniques, rigorous research methods and committed staff provide solid information to help subscribers make the best possible investment decisions. For more information go to www.investorsobserver.com.

All stocks and options shown are examples only-- not recommendations to buy or sell. Our picks do not represent a positive or negative outlook on any security.  Potential returns do not take into account your trade size, brokerage commissions or taxes--expenses that will affect actual investment returns. Stocks and options involve risk, thus they are not suitable for all investors. Prior to buying or selling options, a person should request a copy of Characteristics and Risks of Standardized Options available at http://www.cboe.com/Resources/Intro.aspx. Privacy policy available upon request.

SOURCE InvestorsObserver


Quelle: PR Newswire  

SK 45,91 $ SKP -1,16 Pott +530,63% buran und MfG und danke und SCHÖN
 

Zeit    Kurs Stück
  08:56:25§32,836 € 180
  08:08:29§33,50 € 230
__________________
GRATULATION  

Mylan Launches Generic Prandin® Tablets
20:20 23.01.14

PR Newswire

PITTSBURGH, Jan. 23, 2014

PITTSBURGH, Jan. 23, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg. This product is the generic version of Novo Nordisk's Prandin®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.(1) The company received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.

Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg, had U.S. sales of approximately $212.95 million for the 12 months ending Sept. 30, 2013, according to IMS Health.

Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.

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 1,200 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)  Repaglinide tablets are not indicated for patients with diabetic ketoacidosis or Type 1 diabetes.  It should not be used with gemfibrozil, NPH-insulin or in patients with a known hypersensitivity to the drug.

SOURCE Mylan Inc.


Quelle: PR Newswire  

Medicines Business Partner for India
06:35 31.01.14

PR Newswire

PITTSBURGH and MUMBAI, India, Jan. 31, 2014

PITTSBURGH and MUMBAI, India, Jan. 31, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its India-based subsidiary Mylan Pharmaceuticals Private Limited has been named Gilead Sciences, Inc.'s (Nasdaq: GILD) exclusive branded medicines business partner for India.

Under the agreement, Mylan will market and distribute in India Gilead's:

HIV therapies Viread® (tenofovir disoproxil fumarate), Truvada® (emtricitabine/tenofovir disoproxil fumarate) and the newer single tablet regimen Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
AmBisome® (amphotericin B liposome for injection), a treatment for life-threatening, systemic fungal infections, which is also used to treat the parasitic disease visceral leishmaniasis
Viread® for its indication as a treatment for chronic hepatitis B virus (HBV) infection.
Gilead has partnered with Mylan since 2006, granting the company rights to manufacture and sell their own generic versions of licensed Gilead HIV therapies in India and up to 111 developing world countries where the HIV epidemic affects millions of individuals. Mylan will continue to maintain these rights, in addition to those in this new agreement.

Mylan CEO Heather Bresch commented, "This further extension of our collaboration with Gilead builds off of our existing successful partnership manufacturing and supplying high-quality, cost-effective generic antiretroviral therapy for those in resource challenged countries, delivering on our mission of providing access to high quality medicine to the world's seven billion people."

Gilead's executive vice president of Corporate and Medical Affairs, Gregg H. Alton said, "The appointment of Mylan as our branded medicine business partner in India is a result of their strong knowledge of the Indian healthcare system and demonstrated capabilities of supporting and distributing antiretroviral therapies. We have established an excellent working relationship with Mylan over the past few years, and believe that their operations in India will allow the company to best serve the needs of patients in that country."

In addition to distributing branded Gilead medicines, Mylan will manage regulatory and pharmacovigilance activity, such as adverse event reporting, as well as broader medical education initiatives.

Mylan and HIV in India

Mylan has one of the largest field forces exclusively specializing in HIV/AIDS in India. In September 2012, Mylan was selected as a leading supplier of antiretroviral medicine to India's National AIDS Control Organization (NACO). NACO is a division of India's Ministry of Health and Family Welfare and is responsible for overseeing HIV/AIDS control programs in India. India is home to the world's third largest population of people with HIV/AIDS, with approximately 2.4 million people living with the disease.

Gilead Medicines

Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is a complete once-daily single tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive. (U.S. approval, 2012)

Truvada® (emtricitabine/tenofovir disoproxil fumarate) is a fixed-dose once-daily combination pill containing Viread and Emtriva. It is used in combination with other antiretroviral agents for the treatment of HIV infection in adults and pediatric patients 12 years of age and older (U.S. approval, 2004; EU approval, 2005). Once-daily Truvada is also approved for use in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. (U.S. approval, 2012)

Viread® (tenofovir disoproxil fumarate) is a once-daily oral nucleotide reverse transcriptase inhibitor (NtRTI) for the treatment of HIV infection in patients 2 years of age and older in combination with other antiretroviral agents. (First U.S. approval, 2001; EU approval, 2002.) Viread is also approved as a treatment for chronic hepatitis B in adults and pediatric patients 12 years of age and older. (U.S. and EU approval, 2008)

Viread® is also indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated and decompensated liver disease and pediatric patients 12 years of age and older. (U.S. and EU approval, 2008)

AmBisome® (amphotericin B liposome for injection) is a treatment for life-threatening, systemic fungal infections in adults. (EU approval, 1990; U.S. approval, 1997). Astellas Pharma US, Inc. commercializes the product in the U.S. and Canada.

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 more than 1,300 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  

Zeit    Kurs Stück
  15:54:28§33,23 € 100
_________________
GRATULATION
 

Zeit    Kurs Stück
  13:44:15§33,56 € 91
  13:42:42§33,56 € 209
  10:56:47§33,629 € 100
__________________
GRATULATION

buran und MfG und SCHÖN und schön wenn alle Eierlikörchen Tanten sich inne Runde verstehen und ooooooh ja watt iss datt doch nich allet MYLAN schön schön schön  

Börsenbuch http://www.ariva.de/mylan-aktie/times_and_sales?boerse_id=40 GrB

..also ich das buran sach ja immer ..wenn alle Menschen und Anleger ..so schön wären wie ich das buran ..wär ja die Welt und Börsenwelt noch viel schöner ..verstehste mein Mylan Anteilshaber mein Schöner

Kosmonova buran,Die Börsen Ticker Mylan Sissi Tausendschön  

HertrazTM, in India
06:35 03.02.14

PR Newswire

MUMBAI and PITTSBURGH, Feb. 3, 2014

MUMBAI and PITTSBURGH, Feb. 3, 2014 /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 the world's first trastuzumab biosimilar in India. The product, which will be marketed by Mylan under the brand name HertrazTM, is a biosimilar to Roche's Herceptin®. Hertraz is indicated for the treatment of HER2-positive metastatic breast cancer and is available in two strengths, 440 mg and 150 mg.  

(Photo - http://photos.prnewswire.com/prnh/20140203/NE57237 )

Mylan CEO Heather Bresch commented: "Mylan is excited to offer Hertraz to the thousands of women in India suffering from metastatic breast cancer who are in need of a high quality, more affordable treatment option. The launch of Hertraz not only represents a significant milestone in our biosimilars development program with Biocon, but, more importantly, supports our mission to expand access to high quality medicine around the world and demonstrates our progress against one of Mylan's key future growth drivers."

Mylan President Rajiv Malik added: "The launch of Hertraz is of particular significance as it represents both Mylan's first biosimilar and the world's first trastuzumab biosimilar. We look forward to expanding our portfolio of high quality and affordable biosimilar offerings, particularly in the oncology care segment, in India and around the world in the coming years."

Hertraz was approved by the Drug Controller General of India. In support of this approval, Mylan conducted an extensive series of physicochemical and functional assays to demonstrate similarity to the reference brand Herceptin. These analytical methodologies confirmed the high degree of molecular similarity as well as biological activity of Hertraz. In addition, Mylan conducted a multi-center clinical trial to demonstrate comparable safety and efficacy to the reference product.

Trastuzumab is one of the five biologic products Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercialization rights for biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries and co-exclusive commercialization rights with Biocon for product in India.

According to IPSOS, trastuzumab had sales in India of approximately $21 million for the 12 months ended Dec. 31, 2012.

Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.

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 1,300 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
  05.02.14     43,55     43,68§42,43 43,44 $ 4.920.465 197 M

buran und MfG und danke and rock rock rock rock ROCK  

Datum Erster Hoch Tief Schluss     Stücke Volumen
  05.02.14    32,052    32,052§31,619 31,619 € 530 16.908


buran und MfG und TOP SECRET  

Datum Erster Hoch Tief Schluss     Stücke Volumen
  05.02.14    31,948    32,321§31,948 32,321 € 110 3.537

buran & Tradegate,Die Börsen Ticker Mylan Klarinettistinnen Mephisto Elektra  

Adresse 1500 Corporate Drive, Suite 400
Canonsburg, PA 15317, USA
  Postfach
   Telefon +1-724-514-1800          §
  Internet§http://www.mylan.com
    E-Mailinfo@amstock.com§
IR Telefon +1-724-514-1813
Kontaktperson§Kris King
@Kosmonova buran,ISS Orbit oder @Jana,Karl Marx Stadt  

Celebrex® Patent Suit11:35 13.03.14


PR Newswire

PITTSBURGH, March 13, 2014

PITTSBURGH, March 13, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that the United States District Court for the Eastern District of Virginia has ruled invalid a patent, United States Patent No. RE44,048, related to Pfizer's Celebrex® (celecoxib) 50 mg, 100 mg, 200 mg  and 400 mg capsules.

Mylan was sued by G.D. Searle LLC and Pfizer Asia Pacific PTE, Ltd. for alleged infringement of this patent in connection with Mylan's Abbreviated New Drug Application (ANDA) for its generic version of Celebrex.  

Mylan expects to launch its generic version of Celebrex in May 2014, pending final approval of its ANDA by the U.S. Food and Drug Administration (FDA). Based on available information, Mylan believes it may be entitled to 180 days of shared generic market exclusivity on the 100 mg, 200 mg and 400 mg strengths, subject to the FDA's determination that the product qualifies for an award of exclusivity under the provisions of the Hatch-Waxman Act.

Celebrex® is indicated for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea. For the 12 months ended December 31, 2013, Celebrex® had total U.S. sales of approximately $2.2 billion.

This press release includes statements that constitute "forward-looking statements," including with regard to 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: 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 more than 1,300 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/mylan-aktie/news GrB