Mylan Confirms First-to-File Patent Challenge Relating to NEXAVAR®
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`Feb 09, 2015
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`Mylan Confirms First-to-File Patent Challenge
`Relating to NEXAVAR®
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`- Expects to be eligible for 180days of marketing exclusivity -
`PITTSBURGH, Feb. 9, 2015 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that it and its
`subsidiary Mylan Pharmaceuticals have been sued by Bayer Healthcare LLC, Bayer Healthcare
`Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., in connection with the filing of an Abbreviated New
`Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Sorafenib Tablets, 200 mg.
`This product is the generic version of NEXAVAR®, which is indicated for the treatment of certain types of
`cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
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`Mylan believes that it is the first company to have filed a substantially complete ANDA containing a
`Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity
`upon receiving final FDA approval. The plaintiffs filed suit against the Mylan companies in the United States
`District Court in the District of Delaware.
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`For the 12 months ending Dec. 31, 2014, NEXAVAR had U.S. sales of approximately $48 million, according
`to IMS Health.
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`Currently, Mylan has 283 ANDAs pending FDA approval representing $107.1 billion in annual sales,
`according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities,
`representing $27.2 billion in annual brand sales, for the 12 months ending June 30, 2014, 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 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 25,000 people is dedicated to
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`http://www.mylan.com/news/press-releases/item?id=123278
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`NCI Exhibit 2011
`Page 1 of 4
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`Mylan Confirms First-to-File Patent Challenge Relating to NEXAVAR®
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`improving the customer experience and increasing pharmaceutical access to consumers around the world.
`Learn more at mylan.com.
`
`Private Securities Litigation Reform Act of 1995— A Caution Concerning Forward-Looking
`Statements
`
`This press release includes statements that constitute "forward-looking statements," including with regard to
`product approvals, the expected first-to-file status, pending litigation, and marketing of products. 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; strategies by competitors or other third parties
`to delay or prevent product introductions; risks inherent in legal and regulatory processes; uncertainties and
`other 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.
`
`To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mylan-
`confirms-first-to-file-patent-challenge-relating-to-nexavar-300032844.html
`
`SOURCE Mylan Inc.
`
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`http://www.mylan.com/news/press-releases/item?id=123278
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`NCI Exhibit 2011
`Page 2 of 4
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`Mylan Launches Generic Seasonale® Tablets - May 5,2015
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`News
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`Mylan Launches Generic Seasonale® Tablets
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`Print
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`POTTERS BAR, England and PITTSBURGH, May 5, 2015 /PRNewswire/ -- Mylan N.V. (NASDAQ:
`MYL) today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15
`mg/0.03 mg, which is the generic version of Teva's Seasonale® Tablets. 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, which is indicated for the prevention of pregnancy in women
`who elect to use oral contraceptives as a method of contraception.(1) Mylan's immediate shipment of
`Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg represents the company's tenth
`oral contraceptive product launch in the U.S.
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`Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg had U.S. sales of approximately
`$57.3 million for the 12 months ending December 31, 2014, according to IMS Health.
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`Currently, Mylan has 273 ANDAs pending FDA approval representing $106.9 billion in annual sales,
`according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities,
`representing $31.1 billion in annual brand sales, for the 12 months ending December 31, 2014,
`according to IMS Health.
`
`Mylan is a global pharmaceutical company committed to setting new standards in healthcare. 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 around
`1,400 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 about 145 countries and territories. Our workforce of approximately 30,000
`people is dedicated to creating better health for a better world, one person at a time. Learn more at
`mylan.com.
`
`(1) Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive
`use and this risk increases with age. Women who use oral contraceptives should be advised to not
`smoke. Consult your physician prior to beginning oral contraceptive use.
`
`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968, Kris King (Investors), 724.514.1813
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`http://newsroom.mylan.com/index.php?s=2429&item=123309
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`NCI Exhibit 2011
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`Mylan Launches Generic Seasonale® Tablets - May 5,2015
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`Page 2 of 2
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`http://newsroom.mylan.com/index.php?s=2429&item=123309
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`NCI Exhibit 2011
`Page 4 of 4