Galderma Announces Positive Results Of Study Evaluating A Regimen Of Epiduo Gel And Doxycycline 100mg For Patients With Significant Acne

–Results Could Help Redefine Acne Treatment Regimens and Validate Established Consensus Guidelines–

Fort Worth, TX – February X, 2009 – Results from the ACCESS study found that the addition of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1% / 2.5% to doxycycline 100 mg proved to be a powerful treatment regimen for patients who present more severe acne. ACCESS (Acne Combination Evaluation Study in Severe Patients), sponsored by Galderma Laboratories L.P., is a vehicle-controlled, multicenter, double-blind study that evaluated the efficacy and safety of combination therapy using Epiduo® Gel, FDA approved for the treatment of acne, with doxycycline 100 mg in patients with severe acne. In the ACCESS trial, severe acne was defined as having a minimum of 20 inflammatory lesions, 30 to 120 noninflammatory lesions and no more than 3 nodulocystic lesions. The study results are published in the February issue of the peer-reviewed journal Cutis. The regimen of Epiduo® Gel and oral doxycycline demonstrated a 72 median percent reduction in inflammatory lesion count at week 12.

The established guidelines by the Global Alliance for the Treatment of Acne published in 2009, recommended that in patients with more severe acne, the addition of oral antibiotics such as doxycycline 100 mg to topical therapies is recommended. In patients with mild to moderate acne, use of a topical retinoid and a topical antimicrobial is the recommended first-line treatment.

The ACCESS study, involving 459 patients, is the first controlled trial to formally evaluate the safety and efficacy of a treatment regimen involving Epiduo® Gel (adapalene and benzoyl peroxide), with oral antibiotics,in patients who present more severe acne vulgaris. Patients were randomized in a 1:1 ratio to receive doxycycline (100 mg tablet) once daily and either Epiduo® Gel or gel vehicle once daily for 12 weeks.

Patients in the Epiduo® Gel with doxycycline study arm demonstrated significant efficacy as early as week two compared to the vehicle/doxycycline arm, with total median lesion count reductions of21% and 13%, resp.; (P<,.001). At week 12, this regimen was superior to vehicle/doxycycline in reducing total, inflammatory, and non-inflammatory lesion counts. Additionally, the Epiduo Gel arm showed a significant reduction in Propionibacterium acnes (P. acnes) using the VISIATM System. Patients in the Epiduo® Gel arm reported overall satisfaction with treatment, including the efficacy and speed of onset of action, and many expressed willingness to use this treatment regimen again.

Overall, the safety and tolerability evaluation of Epiduo® Gel with doxycycline was similar to that of vehicle with doxycycline. Stinging and burning was the most frequently reported cutaneous side effect, and was mostly mild. The dropout rate for the study was less than 1 percent. The incidence of related adverse events was low (11.8 percent), and those reported were primarily gastrointestinal, a common symptom for patients taking doxycycline. Other patients in the study reported other dermatological adverse events including dryness, irritation and eyelid irritation. "As a dermatologist, I typically prescribe Epiduo® Gel to treat mild to moderate acne patients and achieve very positive results, and I find that combination treatment with an antibiotic is often the best regimen for my patients who are suffering from severe acne," said Dr. Linda Stein Gold, director of clinical research and division head of dermatology at Henry Ford Hospital in Detroit and an investigator in the ACCESS clinical study. "One exciting finding of the ACCESS study was Epiduo® Gel’s ability to reduce P. acnes, effectively targeting a causative factor of acne. This study confirms Epiduo® Gel’s place in treating a wide range of acne including more severe acne. ACCESS helps redefine the acne regimen.”

"The 2009 FDA approval of Epiduo® Gel showcases Galderma’s ongoing innovation in improving acne treatments.” said François Fournier, President, North America, Galderma Laboratories, L.P. “The ACCESS study is an example of Galderma’s commitment to providing physicians with the strong clinical evidence and effective therapeutic options they need to treat a broad spectrum of patients in the dermatology setting.” About Galderma Galderma, created in 1981 as a joint venture between Nestle and L'Oreal, is a fully-integrated specialty pharmaceutical company dedicated exclusively to the field of dermatology. The Company has a presence in 65 countries with over 1,000 sales representatives and is committed to improving the health of skin with an extensive line of products across the world that treat a range of dermatological conditions including: acne, rosacea, fungal nail infections, psoriasis & steroid-responsive dermatoses, pigmentary disorders, medical solutions for skin senescence and skin cancers. With a research and development center in Sophia Antipolis, France, Galderma has one of the largest R&D facilities dedicated exclusively to dermatology. Leading dermatology brands include Differin®, MetroGel 1%® , Rozex®, Clobex®, Tri-Luma®, Loceryl®, Cetaphil®, Vectical•, Silkis® and Epiduo®.

For more information on Galderma, visit www.galdermaUSA.com<http://www.galdermaUSA.com>. Important Safety Information

Epiduo® Gel is a retinoid and antimicrobial combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older. The most common adverse events associated with use of Epiduo®Gel are erythema, scaling, dryness, stinging and burning. In addition, in clinical trials, adverse events reported in greater than 1% of patients treated with the Gel included contact dermatitis and skin irritation. Excessive exposure to sunlight and sunlamps should be avoided during treatment, and use of sunscreen products and protective clothing is recommended. Concomitant use of irritating topical products (like products containing resorcinol, salicylic acid or sulfur) should be avoided. Instruct patients to avoid the eyes, lips and mucous membranes when applying Epiduo® Gel. Epiduo® Gel has not been tested in pregnant or nursing women, or with the elderly. Pregnancy Category C.

 

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Jamie M. Danz Associate

WCG 1250 24th St. NW I Suite 300 I Washington, DC I 20037 direct 202.621.2886 cell 631.807.3131 email jdanz@wcgworld.com

Posted: February 2010

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