FORT WORTH, Texas, Feb. 26 /PRNewswire-FirstCall/ -- Coria Laboratories, the newly expanded dermatology division of Valeant Pharmaceuticals International , today announced six data presentations on Acanya Gel at the 67th Annual Meeting of the American Academy of Dermatology (AAD), taking place March 6 - 10, 2009, at the Moscone Center, San Francisco. The presentations demonstrate the efficacy and safety of once daily Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) in treating patients with moderate to severe acne vulgaris.
“Data to be presented at AAD will confirm the superior efficacy of Acanya Gel over active ingredients and vehicle for both inflammatory and non-inflammatory acne lesions, while showing favorable safety and tolerability in patients with moderate to severe acne vulgaris,” said Steve Clark, president of Coria Laboratories. “Other highlights include a presentation on how Acanya Gel was developed to enhance the bioavailability of benzoyl peroxide while minimizing the risk of skin irritation, a discussion on Acanya Gel’s role in effective management of adolescent acne, and a session on the importance of Patient Reported Outcomes in the treatment of acne vulgaris.”
Following are details for each poster presentation. (All times are Pacific Standard Time. All presentations are located in Moscone Center North, Hall E)
Friday, March 6, 2009, 11:20 a.m.
Abstract #717
Poster Discussion: Can delivery be enhanced and skin irritation minimized using a lower concentration of benzoyl peroxide in a fixed combination product?
Presenter: Jim Del Rosso, D.O., Las Vegas Skin & Cancer Clinic, Las Vegas, Nevada
Friday, March 6, 2009, 11:30 a.m.
Abstract #718
Poster Discussion: Assessing efficacy of a fixed combination of clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in the treatment of severe acne
Presenter: Michael Gold, M.D., Tennessee Clinical Research Center, Nashville, Tennessee
Friday, March 6, 2009, 12:30 p.m.
Abstract #724
Poster Discussion: Patient reported outcomes using a fixed combination clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel for the treatment of moderate to severe acne in 2,813 subjects
Presenter: Jonathan Weiss, M.D., Gwinnett Clinical Research Center, Snellville, Georgia
Friday, March 6, 2009, 2:50 p.m.
Abstract #738
Poster Discussion: Efficacy of a fixed combination clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in moderate to severe acne
Presenter: Diane Thiboutot, M.D., Department of Dermatology, the Pennsylvania State University College of Medicine, Hershey, Pennsylvania
Friday, March 6, 2009, 3:00 p.m.
Abstract #739
Poster Discussion: Safety and cutaneous tolerability of a fixed combination clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel for the once-daily treatment of moderate to severe acne
Presenter: Diane Thiboutot, M.D., Department of Dermatology, the Pennsylvania State University College of Medicine, Hershey
Friday, March 6, 2009, 3:10 p.m.
Abstract #740
Poster Discussion: Managing moderate to severe acne in adolescents: Benefits of a fixed combination clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in a subpopulation of 1,755 subjects
Presenter: Lawrence Eichenfield, M.D., Department of Dermatology, University of California, San Diego School of Medicine, San Diego, California
About Acanya Gel
Acanya Gel is the only FDA-approved fixed combination antibiotic and benzoyl peroxide (BPO) medication for once-daily treatment of both non-inflammatory and inflammatory lesions of acne. Formulated in an aqueous-based, alcohol-free gel, Acanya Gel was optimized to provide enhanced bioavailability of BPO, creating an effective and well tolerated product. In pivotal Phase III clinical trials, Acanya Gel showed superior efficacy to the vehicle gel and either individual active ingredient, while demonstrating excellent tolerability and very high patient satisfaction scores.
Acanya Gel was developed by Arcutis Pharmaceuticals, now a part of Coria Laboratories, a division of Valeant Pharmaceuticals International. Acanya Gel is protected by two U.S. Patents and has pending patent applications. More information about Acanya Gel can be obtained at http://www.AcanyaGel.com.
Indication and Important Safety Information for Acanya Gel
Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. In controlled clinical trials, the following application-site adverse reactions occurred in less than 0.2% of patients treated with Acanya Gel: application-site pain (0.1%), application-site exfoliation (0.1%), and application-site irritation (0.1%). Patients are advised to avoid applying in mouth, eyes, or nose or on lips, and to minimize sun exposure following the application of Acanya Gel.
About Coria Laboratories
Coria Laboratories is the dermatology division of Valeant Pharmaceuticals International. With its acquisition of Coria Laboratories Ltd. in October 2008, Valeant has created a fully integrated portfolio of specialty pharmaceutical products focused on medical dermatology. Coria Laboratories combines a commercial organization with management expertise, a proven sales force and a goal of developing and marketing innovative products, positioning Coria Laboratories for dermatology industry leadership going forward. Coria Laboratories is committed to establishing a tradition of unparalleled service to the dermatology community, with the critical goal of supporting dermatologists and their practices through greater patient satisfaction with therapy. For more information, please visit http://www.corialabs.com.
About Valeant Pharmaceuticals:
Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology. More information about Valeant can be found at http://www.valeant.com.
FORWARD-LOOKING STATEMENTS:
This press release contains forward-looking statements, including, but not limited to, statements regarding the efficacy of Acanya and favorable safety profile. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties related to the data to be presented at AAD that will confirm the superior efficacy of Acanya Gel and other risks and uncertainties discussed in the company’s annual report or Form 10-K for the years ended December 31, 2007 and other filings with the SEC. Valeant wishes to caution the reader that these factors are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. Valeant also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this release. The company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this release or to reflect actual outcomes.
CONTACT: investors, Laurie W. Little, +1-949-461-6002,
laurie.little@valeant.com, or media, Carole Melis, +1-650-342-5686,
clmcomm1@gmail.com, both for Valeant Pharmaceuticals International
Web site: http://www.valeant.com/
http://www.AcanyaGel.com/
http://www.corialabs.com/
