Acanya(TM) Gel, A New Treatment For Moderate To Severe Acne, Launched By Coria Laboratories

Main Category: Dermatology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 07 Mar 2009 - 1:00 PDT

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Coria Laboratories, the newly expanded dermatology division of Valeant Pharmaceuticals International (NYSE: VRX), announced the commercial launch of Acanya(TM) Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) indicated for the once-daily treatment of acne vulgaris in patients 12 years and older.

Evaluated in clinical studies enrolling over 3,200 subjects with moderate to severe acne vulgaris, Acanya Gel is the only fixed combination antibiotic and benzoyl peroxide (BPO) medication FDA-approved for the once-daily treatment of both non-inflammatory and inflammatory lesions of acne.

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. Results of the 2,813-patient study were reported in the November issue of the Journal of the American Academy of Dermatology.

According to Diane Thiboutot, M.D., a Phase III trial investigator, "Use of combination therapy is recommended at the initiation of acne therapy to inhibit multiple pathogenic factors. The new fixed combination, Acanya Gel, is an effective, safe, and well-tolerated topical product for treating patients with moderate to severe inflammatory and non-inflammatory acne. In addition, high levels of patient satisfaction with Acanya Gel point to the potential for increased patient adherence to treatment, and thus, to improved clinical outcomes."

Phase III Clinical Results

Efficacy: Acanya Gel showed a 55% mean reduction in inflammatory lesions and a 43% mean reduction in non-inflammatory lesions at Week 12. Furthermore, 39% of patients treated with Acanya Gel considered their moderate to severe acne to be 'clear' or 'almost clear' at Week 12, and importantly reported marked improvement as early as two weeks.

Tolerability: The incidence of adverse drug reactions was low and similar across all treatment groups. The majority (greater than or equal to 97%) were mild to moderate in severity. 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%). Given the potential for skin irritation with fixed combination products containing higher concentrations (>2.5%) of BPO, no patient on Acanya discontinued treatment because of local signs or symptoms of stinging, burning, itching, erythema, or scaling, and in no patient were these severe. Mean scores for each local sign/symptom were <1 (1=mild) and comparable to individual active ingredients and vehicle.

Patient Satisfaction: Patient satisfaction data collected in the Phase III program showed significantly greater mean satisfaction scores with Acanya Gel at Week 12 than with prior acne therapy. Indeed 81% of patients were 'satisfied' with Acanya Gel at the end of treatment.

Acne: Widespread Condition

Acne vulgaris is a common skin disorder affecting 40 to 50 million Americans, or about 85 percent of people, at some point in their lives. The disorder is thought to be caused by multiple factors. Overproduction of sebum, a normal oily substance on the skin surface, combined with dead skin cells that are abnormally shed from the hair follicle, lead to plugging of the follicle. This allows skin bacteria, Propionibacterium acnes, to multiply and cause inflammation in the skin in the form of an acne lesion. As a result, combination therapy targeting the multiple components of acne is now commonplace. In the past year, more than five million patients with acne in the U.S. sought treatment from a physician, resulting in over 17 million prescriptions filled, according to data from Verispan and IMS.

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 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 (NYSE: VRX) 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 potential for increased patient adherence to treatment, improved clinical outcomes and other risks and uncertainties discussed in the company's annual report or Form 10-K for the years ended December 31, 2008 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.

Valeant Pharmaceuticals International
http://www.valeant.com

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