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Pharma Company Submitting FDA Application to Begin Studies in Patients with Sport Injuries Using a Through-the-Skin Delivery System
Montgomery, Alabama, March 14, 2005 - ProEthic Pharmaceuticals, Inc., a privately funded Montgomery, Alabama based pharmaceutical company, announced today that it has entered into a $24 million dollar agreement with Endo Pharmaceuticals, Inc. (Nasdaq: ENDP), to develop and commercialize its once-daily Ketoprofen-containing topical patch within the U.S. and Canada.
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.
Ketoprofen TDS is an once-daily Transdermal patch, which resembles a small piece of bandaging tape, that delivers Ketoprofen locally for treatment of pain associated with localized non-dermal soft-tissue injury such as ankle sprains and other sports related injuries. Ketoprofen is a well characterized non-steroidal anti-inflammatory drug (NSAID) that provides a steady, continuous influx of the active drug directly to the inflamed area. By delivering therapeutic dosages of the drug directly to the site of the injury- as opposed to being taken orally and absorbed into the bloodstream through the stomach- the Ketoprofen patch reduces the likelihood of potentially dangerous gastro-intestinal side effects that commonly occur with oral NSAIDs. NSAIDs are medications that yield analgesic relief by reducing inflammation. Traditional NSAIDs are aspirin, ibuprofen and Ketoprofen. In 2003, prescription NSAIDs achieved sales over $10.1 billion.
Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain products. Through its Endo Pharmaceuticals Inc. subsidiary, the company researches, develops, produces and markets a broad offering of both branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information including this and past press releases of Endo Pharmaceutical Holdings Inc., is available online at www.endo.com. Contact: Bill Newbould, Endo Pharmaceuticals Inc. (610) 558-9800
ProEthic Pharmaceuticals, Inc. is a privately funded specialty pharmaceutical company that acquires, develops and markets niche prescription products. ProEthic markets its branded prescription products to primary care and specialty physicians in 31 states. The Company develops and commercializes proprietary formulations of previously approved compounds and selectively seeks regulatory approval to market well characterized compounds for new therapeutic indications. ProEthic has built its product portfolio and development pipeline through a combination of internal development and acquisition of mid to late-stage drug candidates.
