CollaGenex Pharmaceuticals Receives FDA Approval for Oracea(TM)
Tuesday May 30, 7:00 am ET
Commercial Launch to Dermatologists of First Orally-Administered Treatment for Rosacea Planned for July 2006
NEWTOWN, Pa.--(BUSINESS WIRE)--May 30, 2006--CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI - News) today announced that the U.S. Food & Drug Administration (FDA) has approved Oracea(TM) for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. Oracea is the first FDA-approved, orally-administered, systemically-delivered drug to treat rosacea, a dermatologic condition that affects an estimated 14 million adults in the U.S. CollaGenex plans to launch Oracea to the dermatology community in July 2006.
Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, said, "Rosacea is a chronic inflammatory skin condition affecting the facial appearance of millions of people. Our New Drug Application for Oracea included highly significant results from two pivotal Phase III clinical trials that demonstrated the efficacy and safety of this anti-inflammatory drug in the treatment of the inflammatory lesions of rosacea in adult patients. Oracea provides dermatologists and rosacea-sufferers a safe and effective treatment with the convenience of once-a-day oral administration."
Colin Stewart, president and chief executive officer, stated, "Oracea is the first of a series of dermatology products we have in development, and we are very pleased that our NDA was approved by the FDA within 10 months of submission. Sufficient quantities of Oracea capsules have been manufactured for launch and can now be packaged for distribution to the trade in July. Over the past six months, we have built a first-rate specialty sales force to launch Oracea, and all of our representatives were fully trained and in their territories by the end of April. This is an extremely exciting time for CollaGenex, and we look forward to providing dermatologists and their patients with this exciting new therapy to treat rosacea." |
