12/7/2010 10:48:04 AM
MORRISTOWN, N.J. and HYDERABAD, India, Dec. 7, 2010 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) and Natco Pharma Limited (BSE: 524816) today confirmed an exclusive, U.S. development and license agreement, to develop and commercialize lenalidomide 5, 10, 15 and 25 mg tablets. The companies also confirmed that Natco has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lenalidomide 5, 10, 15 and 25 mg product. Natco's lenalidomide tablets are generic versions of Celgene's Revlimid ® Tablets.
Based on available information, the companies believe that Natco may be the "first applicant" to file an ANDA for the 5, 10, 15 and 25 mg generic versions of Revlimid® and, should the ANDA be approved, may be entitled to 180 days of generic market exclusivity.
Upon successful commercialization, Watson and Natco will share net profits on sales. Other terms of the agreement have not been disclosed. Watson will assume responsibility for ongoing regulatory, legal, and commercial expenses related to Natco's lenalidomide product.
Natco Pharma Limited is a specialty pharmaceutical company developing, manufacturing, and marketing pharmaceutical products. Natco is headquartered in Hyderabad, Andhra Pradesh, INDIA. Natco has leadership position in Oncology segment in India. Apart from a branded generic business, Natco is engaged in Discovery research and development of novel drug delivery systems.
For press release and other company information, visit Natco Pharma Limited's Web site at http://www.natcopharma.co.in
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development 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.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
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 and outcome of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; 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, its subsidiaries, and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid and similar foreign laws, 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 on Form 10-K for the year ended December 31,2009 and Watson's quarterly report on Form 10-Q for the period ended September 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
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SOURCE Watson Pharmaceuticals, Inc.