Watson Confirms Rapamune Patent Challenge
Paragraph IV Litigation Underway -
MORRISTOWN, N.J., April 28, 2010 /PRNewswire via COMTEX/ --Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Pfizer Inc. and Wyeth Pharmaceuticals Inc. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for sirolimus tablets in the 1 mg and 2 mg strengths. Watson's ANDA is for a generic equivalent of Wyeth's Rapamune(R) tablets product. The suit was filed on April 28, 2010 in the United States District Court for the District of Delaware.
Pursuant to the Hatch-Waxman Act, Watson previously notified Pfizer and Wyeth that Watson's ANDA contains a paragraph IV certification asserting that U.S. Patent No. 5,100,899 is invalid, unenforceable and /or will not be infringed by the commercial manufacture, use or sale of the drug products described in Watson's ANDA. Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the 1 mg and 2 mg generic version of Rapamune(R) and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for those strengths.
Rapamune(R) (sirolimus) tablets are indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. For the twelve months ending February 2010, Rapamune(R) had total U.S. sales of approximately $210.5 million according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.
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 affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts and FDA approvals or actions, if any; the difficulty of predicting the timing or outcome of litigation; 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 annual report for the year ended December 31,2009. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Rapamune(R) is a registered trademark of Pfizer Inc.
SOURCE Watson Pharmaceuticals, Inc.
Posted: April 2010