Mylan Inc. Confirms First-to-File Patent Challenge Relating to Xeloda(R) Cancer Treatment
Expects to qualify for 180 days of sole marketing exclusivity
PITTSBURGH, April 14 /PRNewswire-FirstCall/ -- Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Hoffmann-La Roche Inc. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Capecitabine Tablets, 150 mg and 500 mg, the generic version of Xeloda(R) Tablets, a chemotherapy treatment for breast and colorectal cancer.
Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the product and expects to qualify for 180 days of sole marketing exclusivity once final FDA approval is obtained. Hoffmann-La Roche filed a lawsuit April 8 in the U.S. District Court for the District of New Jersey alleging infringement of U.S. Patent No. 5,472,949.
Xeloda Tablets, 150 mg and 500 mg, had approximately $447 million in sales for the 12 months ending Dec. 31, 2008, according to IMS Health. Currently, Mylan has 117 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.
This press release includes statements that constitute "forward-looking statements," including with regard to the expected first-to-file status and pending litigation. 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: the use of legal, regulatory and legislative 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 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 generics 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.
CONTACT: Media, Michael Laffin, +1-724-514-1968; or Investors, Dan
Crookshank, +1-724-514-1813, both of Mylan Inc.
Web site: http://www.mylan.com/