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Endo Licenses Topical Ketoprofen Patch for US and Canada

Release issued 14th March 2005

Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP - News), announced today that it has entered into an agreement with ProEthic Pharmaceuticals, Inc. for the U.S. and Canadian rights to develop and commercialize a once-daily ketoprofen- containing topical patch originally developed by APR Applied Pharma Research s.a. and further licensed to ProEthic.

Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) generally used for the treatment of inflammation and pain and available in the U.S. only in oral form. Currently in Phase II clinical trials in the U.S., the ketoprofen patch is being developed for the localized treatment of acute pain associated with soft- tissue injuries such as tendonitis or joint sprains and strains. Two Phase III placebo-controlled studies in soft-tissue injury and ankle sprains have been completed in Europe by ProEthic's European partner Applied Pharma Research AG, with statistically significant results.

"We believe that the topical ketoprofen patch, which bypasses the bloodstream, could also offer the added benefit of targeted pain control aimed directly at the injury site with the convenience of once-a-day dosing. We would expect that this has the potential to be an attractive product opportunity compared to systemic agents," said Peter A. Lankau, Endo's president and chief operating officer. The total soft-tissue injury market is currently estimated to be approximately $2.5 billion, primarily consisting of NSAID's and COX-II's.

Under the terms of the agreement, Endo will make a $10.0 million upfront payment and payments of approximately $14.0 million for the achievement of certain regulatory milestones.

Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management products.

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If you want to find out more about the company visit APR Applied Pharma Research S.A. profile.

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