FDA APPROVES COLLAGENEX'S ORACEAL FOR ROSACEA.
CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI), Newton, Pa., has 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."
Rosacea is a dermatologic condition that affects approximately 14 million adults in the U.S. It affects primarily the face and is characterized by the appearance of inflammatory lesions (papules and pustules), erythema (skin redness) and telangiectasia (spider veins). If allowed to progress to a moderate to severe condition, rosacea can cause itching, pain and thickening of the skin. The current U.S. market size for rosacea is estimated to be approximately $500 million.
Oracea is a 40 mg, unique capsule formulation of doxycycline, USP, dosed once-a-day and containing a combination of immediate and delayed release beads. The NDA approval was based primarily upon the safety and efficacy results of two Phase III, double-blinded, placebo-controlled clinical trials. 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% mean reduction, 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.
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on developing and marketing proprietary, innovative medical therapies to the dermatology market. CollaGenex's professional dermatology sales force markets Pandel(R), a prescription topical corticosteroid licensed from Altana, Inc., Alcortin(TM) (1% iodoquinol and 2% hydrocortisone), a prescription topical antifungal steroid combination, and Novacort(TM) (2% hydrocortisone acetate and 1% pramoxine HCl), a prescription topical steroid and anesthetic. Alcortin and Novacort are marketed by the company under a Promotion and Cooperation agreement with Primus Pharmaceuticals, Inc. CollaGenex is preparing to launch Oracea, the first FDA-approved systemic product for the treatment of rosacea, and is conducting a 300-patient, Phase II dose-finding study to evaluate its second dermatology candidate, incyclinide, for the treatment of acne. CollaGenex is also developing COL-118, utilizing the technology acquired in the SansRosa acquisition, as a preclinical topical compound for the treatment of redness associated with rosacea and other skin disorders.
CollaGenex also currently sells Periostat(R), which the company developed as the first pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues and by enhancing bone protein synthesis, and Atridox(R), Atrisorb FreeFlow(R) and Atrisorb-D FreeFlow(R), which are products of QLT Inc., the successor to Atrix Laboratories, Inc., for the treatment of adult periodontitis. Research has shown that certain tetracyclines can be chemically modified to remove their antibiotic effects while retaining the properties that may make them effective in treating diseases involving inflammation and/or destruction of the body's connective tissues.
CollaGenex is evaluating various chemically modified tetracyclines (so called "IMPACS" compounds because they are Inhibitors of Multiple Proteases And CytokineS") to assess whether they are safe and effective in these applications. The company has a pipeline of innovative product candidates with possible applications in dermatology and other disease states. In addition, CollaGenex has acquired the Restoraderm(R) technology, a unique, proprietary dermal drug delivery system, and plans to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties.
For more information, visit http://www.collagenex.com or call 215/579-7388.