Oracea May Become First Oral Rosacea Treatment

CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) announced February 27 that a Marketing Authorization Application (MAA) for Oracea(TM), has been filed with the United Kingdom's Medicines & Healthcare Products Regulatory Agency (MHRA). The UK will act as reference member state in this decentralized procedure. The MAA for Oracea was submitted to the MHRA on February 24, 2006. A New Drug Application for Oracea was filed with the U.S. Food and Drug Administration in August 2005 and has been given a PDUFA date of May 31, 2006. If approved, Oracea will be the first orally administered, systemically delivered drug developed to treat rosacea.

The MAA was based primarily upon the safety and efficacy results of two Phase 3, double-blinded, placebo-controlled clinical trials for Oracea(R). These studies enrolled a total of 537 patients in 28 centers across the U.S. In the two studies, patients receiving Oracea experienced a 61% and 46% mean reduction in inflammatory lesions compared to 29% and 20%, respectively, in patients receiving placebo. The differences were clinically and statistically highly significant (p = less than 0.001 in each study). Side effects of the drug were similar to placebo.

"This is an important step towards maximizing the worldwide opportunity for Oracea," said Colin Stewart, president and chief executive officer of CollaGenex. "If approved by the MHRA, we intend to seek registration for Oracea in other countries of the European Union."