Mylan Announces Settlement Agreement with Novartis Related to Femara(R) First- to-File Opportunity
PITTSBURGH, Dec 02, 2008 -- Mylan Inc. 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 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 Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.