Mylan Announces Fortamet® Settlement Agreement
PITTSBURGH, March 13, 2013
PITTSBURGH, March 13, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into a
settlement agreement with Shionogi Inc. and Andrx that will resolve patent
litigation related to Metformin Hydrochloride Extended-release Tablets USP,
500 mg and 1000 mg. This product is the generic version of Shionogi's
Fortamet^®, and is indicated as an adjunct to diet and exercise to lower blood
Under the terms of the settlement agreement, Mylan may launch a generic
version of Fortamet® on August 1, 2013, or earlier under certain conditions.
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
Metformin Hydrochloride Extended-release Tablets USP, 500 mg and 1000 mg, had
U.S. sales of approximately $125 million for the 12 months ending Sept. 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 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
(1) Metformin Hydrochloride Extended-release Tablets USP should not be used in
patients with renal disease, acute or chronic metabolic acidosis, impaired
liver dysfunction or who have a known hypersensitivity. Patients who have
congestive heart failure, renal disease or are elderly are at increased risk
of Lactic acidosis. In patients suffering from hypoxemia, dehydration or
sepsis, Metformin Hydrochloride should be withheld.
SOURCE Mylan Inc.
Contact: Nina Devlin (Media) +1-724-514-1968; Kris King (Investors)
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