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Mylan Announces Settlement Agreement with Novartis Related to Femara(R) First- to-File Opportunity
Date:12/2/2008

PITTSBURGH, Dec. 2 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis' Femara(R).

Mylan's Vice Chairman and CEO Robert J. Coury commented: "We are very pleased to have reached this agreement, which demonstrates our ability to once again bring to market high quality, affordable medications for the patients who need them the most."

Under the agreement, Mylan is provided a patent license that will enable the company to market Letrozole Tablets, 2.5 mg, prior to the expiration of U.S. Patent No. 4,978,672. Additional terms related to the settlement remain confidential, and the agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Letrozole Tablets, which are used in the treatment of breast cancer, had U.S. sales of approximately $470 million for the 12 months ending Sept. 30.

Mylan was the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for the product. Currently, Mylan has 113 ANDAs pending U.S. Food and Drug Administration approval, 24 of which are potential first-to-file opportunities.

This press release includes statements that constitute "forward-looking statements," including with regard to the settlement, regulatory approvals and Mylan's future business opportunities. 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 t
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SOURCE Mylan Inc.
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