Watson Confirms Velcade® Patent Challenge
Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that Actavis, Inc., which was acquired by Watson in October, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market bortezomib.
Actavis’ ANDA product is a generic version of Millennium Pharmaceuticals’ Velcade ® (bortezomib), which is a proteasome inhibitor, for intravenous or subcutaneous administration, approved for the treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.
Millennium filed suit against Actavis on December 21, 2012, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents.
The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the 12 months ending October 31, 2012, Velcade® had total U.S. sales of approximately $740 million according to IMS Health data
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson’s current perspective of existing information as of the date of this release. It is important to note that Watson’s goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson’s current expectations depending upon a number of factors, risks and uncertainties affecting Watson’s business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers’ facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson’s periodic public filings with the Securities and Exchange Commission, including but not limited to Watson’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 and Watson’s Annual Report on Form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Velcade® is a registered trademark of Millennium Pharmaceuticals, Inc.
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