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Galderma announces approval for Differin gel 0.1 percent in Japan
Date:7/17/2008

Lausanne, Switzerland July 16, 2008 Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, announced today that Japan's Ministry of Health, Labor and Welfare has approved Differin® Gel 0.1% (adapalene), a novel topical treatment for acne vulgaris in Japan. The drug will be marketed in Japan by Galderma KK, the fully-owned Japanese arm of Galderma, and strategic alliance partner Shionogi.

Differin® has been available for over 15 years and is currently marketed in more than 80 countries, where it has become an important therapy for more than 22 million patients. Approval in Japan will reinforce Galderma's presence in the world's second-largest pharmaceutical market. Approval was based on non-clinical and clinical studies, which supported the efficacy and safety of the product for the registration outside Japan and on an extensive local clinical development program, including two phase 3 studies enrolling more than 600 Japanese patients.

A 12-week study of the treatment in 200 Japanese patients demonstrated that treatment with Differin® Gel 0.1% led to a significant reduction in both inflammatory and non-inflammatory lesions, as compared with vehicle treatment, with some patients feeling the benefit after only one week of treatment. A 12-month long-term safety study of more than 400 patients showed that the treatment was safe and remained effective with long-term use.

"The collective results of three recent adapalene studies provide a substantial evidence base for the safe and effective use of adapalene gel 0.1% in Japanese patients with acne," said Clinical Trial Lead Investigator Makoto Kawashima, MD, PhD Department of Dermatology Tokyo Women's Medical University. "The availability of a topical retinoid in Japan will provide greater flexibility for customizing care and improving outcomes for acne patients."

According to the agreement between both firms, Galderma and Shionogi w
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Contact: Dale Weiss
dale.weiss@galderma.com
817-961-5186
WeissComm Partners
Source:Eurekalert

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