Press Release: Positive Results of Phase 4 Clinical Study Evaluating Effects of Oracea Capsules
Positive Results of Phase 4 Clinical Study Evaluating Effects of Oracea Capsules, 40 mg, in Combination with MetroGelÂ® (metronidazole gel), 1%, as Treatment for Rosacea Presented at Annual Meeting of the AAD Patients in the Oracea + MetroGel Group Experienced a Mean Reduction of 13.9 Inflammatory Lesions Compared to 8.5 in the Placebo + MetroGel Group American Academy of Dermatology 65th Annual Meeting NEWTOWN, Pa. -- CollaGenex Pharmaceuticals, Inc. today announced results of a Phase 4 clinical study designed to evaluate the efficacy of combining Oracea(TM) capsules and topical MetroGel in the treatment of rosacea. Study results were presented at the American Academy of Dermatology (AAD) Annual Meeting in Washington D.C. by the lead investigator, Joseph Fowler, MD, Clinical Professor of Dermatology, University of Louisville, Louisville, Kentucky. The trial also evaluated the effectiveness of Oracea for maintenance therapy in the treatment of rosacea. The double-blind, placebo-controlled trial enrolled a total of 72 rosacea patients at 3 centers. The patients were administered either Oracea capsules + MetroGel or Placebo capsules + MetroGel once a day for 12 weeks. MetroGel was discontinued at Week 12, and patients continued to receive either Oracea or Placebo through Week 16. Measurements of the changes in the number of inflammatory lesions were taken at Weeks 4, 8, 12 and 16. The primary efficacy endpoint of the study was the Mean Change in Inflammatory Lesions at Weeks 12 and 16. The study successfully met this endpoint and demonstrated a statistically significant, greater reduction in inflammatory lesions at Weeks 12 and 16 in the Oracea + MetroGel group compared to the Placebo + MetroGel group. Combination Therapy At baseline, the patients in the Oracea + MetroGel group had a mean total inflammatory lesion count of 21.3. At Week 12, this group experienced a reduction in inflammatory lesions of 13.9. In the Placebo + MetroGel patient group, baseline mean total inflammatory lesion count was 18.7. At Week 12, this group experienced a reduction of 8.5 inflammatory lesions. The difference between the two groups was statistically significant (P=0.002). The mean percent reduction in inflammatory lesions was 66.4% in the Oracea + MetroGel group compared to 48.2% in the Placebo + MetroGel group (P=0.008). The difference in the inflammatory lesion count reduction was statistically significant as early as Week 4, when Oracea + MetroGel demonstrated a reduction in inflammatory lesions of 9.7 while Placebo + MetroGel demonstrated a reduction in inflammatory lesions of 2.9 (P=0.0008). â€œThis trial demonstrates that the combination of Oracea and MetroGel results in a faster and greater reduction in the inflammatory lesions of rosacea than MetroGel alone,â€ said Dr. Fowler. â€œDermatologists have limited their use of systemic antibiotics, like doxycycline, in rosacea because of concerns about safety. Oracea contains a dose of doxycycline that is too low to produce an antibiotic effect, but is enough to reduce the inflammation associated with rosacea. The safety profile of Oracea and the results of this study suggest that combination therapy of a topical agent and Oracea should be considered as a first-line treatment for rosacea patients.â€ â€œTopical metronidazole has been the leading rosacea therapy for many years, with over 2 million prescriptions written annually,â€ said David Pfeiffer, Senior Vice President, Sales and Marketing, CollaGenex Pharmaceuticals. â€œA significant portion of these prescriptions are written along with an oral agent. Rosacea patients want to see treatment results quickly. The results of this study suggest that combination therapy with Oracea may be a good approach to enhance patient satisfaction.â€ Maintenance Therapy At Week 16, after MetroGel had been discontinued for four weeks, the patients treated with Oracea alone generally maintained their level of improvement, while the improvement receded in the patients on Placebo. In the Oracea group at Week 16, the patients experienced a mean total reduction of 13.4 inflammatory lesions compared to baseline, while the patients treated with Placebo experienced a mean total reduction of 6.5 inflammatory lesions (P=0.0006). â€œMaintenance therapy for rosacea should take into account patient acceptance as well as safety and efficacy,â€ commented Dr. Fowler. â€œThis study suggests that the results of combination therapy will be maintained for a period of time with Oracea alone. Oracea may be a good maintenance therapy for rosacea patients who prefer to take pills rather than apply gels or creams.â€ About Rosacea Rosacea is a 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, pustules and nodules), 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. About CollaGenex CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on developing and marketing innovative proprietary medical therapies to the dermatology market. In July 2006, CollaGenex launched Oracea(TM), 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 conducting Phase I clinical trials to evaluate COL-118, a topical compound based on the SansRosa(TM) technology, for the treatment of redness associated with rosacea and other skin disorders. CollaGenexâ€™s professional dermatology sales force also 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. 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 â€œIMPACS(TM)â€ 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. To receive additional information on the Company, please visit our Web site at www.collagenex.com, which does not form part of this press release. Forward Looking Statements Statements in this press release regarding managementâ€™s future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the clinical results and commercial potential of Oracea, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. CollaGenex's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including those factors contained in the most recent Form 10-Q for the quarter ended September 30, 2006 under the section "Risk Factors" as well as other documents that may be filed by CollaGenex from time to time with the Securities and Exchange Commission. Forward-looking statements include statements regarding CollaGenex's expectations, beliefs, intentions, goals, strategies, plans or prospects regarding the future and can be identified by forward-looking words such as "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "should", "will", and "would" or similar words. CollaGenex assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Restoraderm(R) is a registered trademark and IMPACS(TM), SansRosa(TM) and Oracea(TM) are trademarks of CollaGenex Pharmaceuticals, Inc. MetroGel(R) is a registered trademark of Galderma Laboratories, Inc. Novacort(TM) and Alcortin(TM) are trademarks of Primus Pharmaceuticals, Inc. Pandel(R) is a registered trademark of Taisho Pharmaceuticals. All other trade names, trademarks or service marks are the property of their respective owners and are not the property of CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries.