Mylan Announces Settlement Agreement with Novartis Related to Femara(R) First- to-File Opportunity
Mylan's Vice Chairman and CEO Robert J. Coury commented: "We are verypleased to have reached this agreement, which demonstrates our ability to onceagain bring to market high quality, affordable medications for the patientswho need them the most."
Under the agreement, Mylan is provided a patent license that will enablethe company to market Letrozole Tablets, 2.5 mg, prior to the expiration ofU.S. Patent No. 4,978,672. Additional terms related to the settlement remainconfidential, and the agreement is subject to review by the U.S. Department ofJustice and the Federal Trade Commission.
Letrozole Tablets, which are used in the treatment of breast cancer, hadU.S. sales of approximately $470 million for the 12 months ending Sept. 30.
Mylan was the first company to file a substantially complete AbbreviatedNew Drug Application (ANDA) containing a Paragraph IV certification for theproduct. Currently, Mylan has 113 ANDAs pending U.S. Food and DrugAdministration approval, 24 of which are potential first-to-fileopportunities.
This press release includes statements that constitute "forward-lookingstatements," including with regard to the settlement, regulatory approvals andMylan's future business opportunities. These statements are made pursuant tothe safe harbor provisions of the Private Securities Litigation Reform Act of1995. Because such statements inherently involve risks and uncertainties,actual future results may differ materially from those expressed or implied bysuch forward-looking statements. Factors that could cause or contribute tosuch differences include, but are not limited to: any legal or regulatorychallenges to the settlement; strategies by competitors or other third partiesto delay or prevent product introductions; risks inherent in legal andregulatory processes; and the other risks detailed in the company's periodicfilings with the Securities and Exchange Commission. The company undertakes noobligation to update these statements for revisions or changes after the dateof this release.
Mylan Inc., which provides products to customers in more than 140countries and territories, ranks among the leading diversified generic andspecialty pharmaceutical companies in the world. The company maintains one ofthe industry's broadest - and highest quality - product portfolios, supportedby a robust product pipeline; owns a controlling interest in the world's thirdlargest active pharmaceutical ingredient manufacturer; and operates aspecialty business focused on respiratory and allergy therapies. For moreinformation, please visit www.mylan.com.
SOURCE Mylan Inc.
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