Healthcare Industry News:  metoprolol 

Biopharmaceuticals Generics

 News Release - May 21, 2007

Watson Enters Into Agreement to Permit Sandoz to Launch Metoprolol Succinate Extended-Release 50 mg Tablets; Relinquishes 180-Day Market Exclusivity

CORONA, Calif., May 21 (HSMN NewsFeed) -- Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical company, announced today that pursuant to an agreement with Sandoz, a subsidiary of Novartis AG, Watson has relinquished its rights to a 180-day period of marketing exclusivity for its 50 mg strength of metoprolol succinate extended-release tablets (the generic equivalent to AstraZeneca PLC's Toprol XL® 50 mg product). Watson was awarded market exclusivity as the first generic applicant to submit an Abbreviated New Drug Application (ANDA) for metoprolol succinate extended-release 50 mg tablets. As a result of Watson's agreement to relinquish its marketing exclusivity, Sandoz has obtained final approval of its ANDA for metoprolol succinate extended-release 50 mg tablets. Watson will be entitled to a share of Sandoz's profits on the sale of the product. Other terms of the agreement were not disclosed. According to IMS Sales data, Toprol XL® extended-release 50mg had 2006 U.S. brand sales in excess of $600 million.

Watson continues to pursue approval of its own pending ANDA for metoprolol succinate extended-release tablets, but does not anticipate obtaining final approval before AstraZeneca's pediatric study market exclusivity commences. Watson believes that under current U.S. Food and Drug Administration (FDA) policy, applicants that do not obtain final approval before AstraZeneca's pediatric study market exclusivity commences would be barred from obtaining final approval until March 18, 2008, when AstraZeneca's pediatric study market exclusivity expires.

Forward-Looking Statement

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. It is important to note that Watson's goals and expectations are not predictions of actual performance. Watson's performance, at times, will differ from its goals and expectations. 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 or other regulatory agency approvals or actions; changes in laws or regulations, including FDA's policy concerning awards of pediatric exclusivity; the inherent uncertainty of financial projections; uncertainties related to the timing or outcome of litigation; and 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, 2006.

Toprol XL® is a registered trademark of AstraZeneca PLC.


Source: Watson Pharmaceuticals

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