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.
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.
For the 12 months ending Dec. 31,
2014, NEXAVAR had U.S. sales of approximately $48 million, according to IMS Health.
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 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.
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SOURCE Mylan Inc.