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Competition for oravescent fentanyl.

Press Release Source: Endo Pharmaceuticals Inc.


Endo Licenses the Rights to Develop and Market Proprietary Sublingual Fentanyl Product From Orexo
Wednesday August 18, 7:00 am ET


CHADDS FORD, Pa., Aug. 18 /PRNewswire/ -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP - News), announced that it has entered into an agreement granting Endo the exclusive rights to develop and market Orexo AB's (a privately held Swedish company) patented sublingual muco-adhesive fentanyl product (Rapinyl(TM)) in North America. Rapinyl(TM) is an oral, fast-dissolving tablet of fentanyl intended for the treatment of breakthrough cancer pain.
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"We are delighted to add this novel proprietary product to our portfolio," said Carol A. Ammon, chairman and chief executive officer of Endo. "We believe that this product is an excellent strategic fit for us and reinforces our continued leadership position in pain management. The benefits of Rapinyl(TM) are believed to include both a fast onset of action and added convenience, which we believe will improve compliance in cancer patients who experience breakthrough pain."

"We are very pleased to be partnering Rapinyl(TM) with Endo Pharmaceuticals for the North American market," said Zsolt Lavotha, president and chief executive officer of Orexo AB. "Endo Pharmaceuticals is a market leader in pain management products, with a strong reputation for research and development as well as marketing and sales. We believe Endo Pharmaceuticals is the ideal partner to fully exploit the potential of Rapinyl(TM) in North America."

Rapinyl(TM) is based on Orexo's unique patented technology for sublingual administration. This novel pharmaceutical preparation is believed to provide rapid absorption of the active substance and a fast onset of action. Currently in Phase II clinical development, this product has demonstrated enhanced absorption characteristics and is intended for the management of breakthrough pain in opioid-tolerant cancer patients. Endo anticipates that it will commence Phase III clinical trials in 2005.

The agreement provides for Endo to make an up-front license fee payment of $10 million, in addition to other license fees and payments based on development and regulatory milestones, which may total up to $22.1 million through FDA approval of Rapinyl(TM)'s New Drug Application. The agreement also provides for double-digit royalties upon commercial sales and may include sales milestones if defined sales thresholds are achieved.

About Endo

A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo Pharmaceuticals Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management products. The company researches, develops, produces and markets a broad product offering of branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at http://www.endo.com.

About Orexo

Orexo AB is a product-focused drug delivery company. Orexo develops, documents and registers innovative pharmaceutical products with clinical benefits based on patented, proprietary technology platforms. The products are developed on the basis of defined therapeutic needs with the objective of reaching a global market. The company is based in Uppsala, Sweden. http://www.orexo.com