PITTSBURGH, Oct. 4 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that it and its subsidiary Mylan Pharmaceuticals Inc. have entered into an agreement to settle pending litigation with UCB Societe Anonyme and UCB Pharma Inc. (collectively, UCB) relating to Levetiracetam Tablets, 250mg, 500mg and 750mg, the generic version of UCB's Keppra(R).
Litigation between Mylan and UCB has been pending in the U.S. District Court for the Northern District of Georgia since March 2004. The lawsuit involved U.S. Patent No. 4,943,639, which expires on July 14, 2008.
Pursuant to the settlement, Mylan has the right to market the 250mg, 500mg and 750mg strengths of Levetiracetam Tablets in the United States on Nov. 1, 2008, provided that UCB obtains pediatric exclusivity for Keppra and Mylan's abbreviated new drug application (ANDA) obtains final approval from the Food and Drug Administration (FDA). If granted, pediatric exclusivity relating to the '639 patent would extend to Jan. 14, 2009. Mylan's entry into the market could come sooner than Nov. 1, 2008, if the FDA does not grant UCB pediatric exclusivity. Additional terms of the settlement are confidential, and the agreement is subject to review by the Department of Justice and the Federal Trade Commission.
Levetiracetam Tablets had U.S. sales of approximately $742 million for the 12 months ending June 30, 2007, for these three strengths.
This press release includes statements that constitute "forward-looking statements," including with regard to the settlement agreement and Mylan's entry into the market. 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: a decision by the DOJ or FTC to challenge the settlement agreement; a decision by the FDA not to grant pediatric exclusivity or final approval; the court's refusal to enter the requested judgment 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 Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas. For more information about Mylan, please visit http://www.mylan.com .
CONTACT: Kris King for Mylan Inc., +1-724-514-1800
Web site: http://www.mylan.com/