Mylan Announces TARCEVA® Settlement Agreement
PITTSBURGH, July 24, 2013
PITTSBURGH, July 24, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into a
settlement agreement with OSI, Pfizer and Genentech that will resolve patent
litigation related to Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150
mg. This product is the generic version of TARCEVA^®, and is indicated in
combination with gemcitabine for the first-line treatment of patients with
locally advanced, unresectable or metastatic pancreatic cancer.
Pursuant to the agreement, pending litigation will be dismissed. All other
terms and conditions of the settlement are confidential, and the agreement
itself is subject to review by the U.S. Department of Justice and the Federal
Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg, had U.S. sales of
approximately $638.7 million for the 12 months ending March 31, 2013,
according to IMS Health.
Currently, Mylan has 174 ANDAs pending FDA approval representing $83.2 billion
in annual sales, according to IMS Health. Thirty-seven of these pending ANDAs
are potential first-to-file opportunities, representing $23 billion in annual
brand sales, for the 12 months ending Dec. 31, 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 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.
Contact: Nina Devlin (Media), 724.514.1968 or Kris King (Investors),
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