Differin Anti-Acne Medication Cleared by FDA

FORT WORTH, Texas, June 3, 1996 -- Galderma Laboratories announced that it has received marketing clearance for Differin(TM) (adapalene gel) Gel, 0.1%, a new topical prescription anti-acne medication.

Differin(TM) Gel is a new synthetic retinoid analogue with advanced receptor selective activity and potent anti-inflammatory and comedolytic properties.

Differin(TM) Gel is the first new retinoid for the treatment of acne since oral isotretinoin (Accutane(R), Roche) was introduced in 1982, and the first new topical retinoid since tretinoin (Retin-A(R), Ortho) in 1972(a). In controlled clinical trials, Differin(TM) Gel was shown to effectively reduce the number and severity of acne lesions after 12 weeks of therapy and has demonstrated greater effectiveness than the highest strength of topical tretinoin gel (0.025% gel). Furthermore, the patients on Differin(TM) Gel experienced significantly less skin dryness and skin irritation(b). Stinging, burning, peeling and skin redness associated with retinoid therapy have been a barrier to patients remaining on their tretinoin acne medication and achieving successful treatment outcomes.

"Retinoid therapy has been recognized for more than 20 years to be excellent acne therapy, but due to the side effects it has always been a double-edged sword limiting its use in many patients," said James Leyden, M.D., professor of dermatology, University of Pennsylvania and a Differin(TM) Gel clinical investigator. "However, the benefit is that Differin(TM) Gel is quite effective and tolerance is very good, even continuing to improve with treatment."

Some adverse effects such as erythema, scaling, dryness, pruritus and burning will occur in 10%-40% of patients. Pruritus or burning immediately after application also occurs in approximately 20% of patients. The following additional adverse experiences were reported in approximately 1% or less of patients: skin irritation, burning/stinging, erythema, sunburn and acne flares. These are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter.

In addition to its excellent tolerability, Differin(TM) Gel offers other benefits:

- It quickly penetrates deeply into hair follicles, where it can exert its anti-inflammatory and comedolytic effects (prevention/reduction of blackheads/whiteheads).

- It is a white, odorless, oil-free and alcohol-free gel that is specifically formulated for the special needs of patients with acne.

Galderma Laboratories plans to make Differin(TM) Gel available to pharmacies in the third quarter of 1996.

Galderma Laboratories, a joint venture of L'Oreal and Nestle, is a leading research-based pharmaceutical company dedicated to developing novel prescription and over-the-counter treatments for dermatological diseases. Devoted exclusively to dermatology, the company is focused on treatments for disease areas including acne, rosacea, psoriasis, eczema and skin infections. Galderma Laboratories is an international skin care products company with its U.S. headquarters located in Fort Worth. (a) Plewig, Gerd and Albert M. Kligman. Acne and Rosacea. New York: Springer-Verlag, p. 556.

(b) A comparison of the efficacy and safety of adapalene gel 0.1% and tretinoin gel 0.025% in the treatment of acne and vulgaris: A multicentre trial. A Shalita, MD, JS Weiss, MD, DK Chalker, MD, et al.; Journal of the American Academy of Dermatology, March 1996.