Galderma Announces Approval for Differin(R) Gel 0.1% in Japan

Thursday, July 17, 2008 General News
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LAUSANNE, Switzerland, July 16 Galderma Pharma S.A., aglobal specialty pharmaceutical company focused on dermatology, announcedtoday that Japan's Ministry of Health, Labor and Welfare has approvedDifferin(R) Gel 0.1% (adapalene), a novel topical treatment for acne vulgarisin Japan. The drug will be marketed in Japan by Galderma KK, the fully-ownedJapanese arm of Galderma, and strategic alliance partner Shionogi.

Differin(R) has been available for over 15 years and is currently marketedin more than 80 countries, where it has become an important therapy for morethan 22 million patients.(1) Approval in Japan will reinforce Galderma'spresence in the world's second-largest pharmaceutical market. Approval wasbased on non-clinical and clinical studies, which supported the efficacy andsafety of the product for the registration outside Japan and on an extensivelocal clinical development program, including two phase 3 studies enrollingmore than 600 Japanese patients.

A 12-week study of the treatment in 200 Japanese patients(2a) ademonstrated that treatment with Differin(R) Gel 0.1% led to a significantreduction in both inflammatory and non-inflammatory lesions, as compared withvehicle treatment, with some patients feeling the benefit after only one weekof treatment.(2b) A 12-month long-term safety study of more than 400patients(3) a showed that the treatment was safe and remained effective withlong-term use.(3b)

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

According to the agreement between both firms, Galderma and Shionogi willco-promote Differin(R) Gel 0.1% with their respective sales forces andShionogi will have sales and distribution rights for the product for a periodof eight years. Commercialization will begin once the product is listed on theNational Health Insurance reimbursement list, a process that is expected to becomplete by autumn 2008.

"The decision by Japan's Ministry of Health, Labor and Welfare isexcellent news for patients and physicians in Japan, who will now have accessto a first-in-class topical retinoid for the treatment of acne," said HumbertoC. Antunes, Chief Executive Officer of Galderma International. "We undertookthe largest acne clinical program ever in Japan, and knew it would be a longjourney to approval. This project underscores Galderma's commitment todermatology in all parts of the world and dedication to improving the qualityof life of acne patients in Japan."

Differin(R) Gel 0.1% is a naphthoic acid derivative with retinoid-likeactivities.(2c) Differin(R) will be the first product to be launched in Japanbelonging to this class of treatment. Differin(R) appears to normalize thedifferentiation of a type of skin cell linked to acne, resulting in fewernon-inflammatory and inflammatory lesions.(2c)

About Acne

Acne vulgaris is one of the most widely experienced chronic skin diseasesworldwide. In recent years, research has led to a greater understanding ofthe pathogenesis of the disease.(4) The disorder begins with the onset ofpuberty and is thought to result from hormonal action on the skin's oil glands(sebaceous glands) leading to plugged pores and outbreaks of spots.(5) It canbe challenging to manage, due to the variability in response to treatment.(2d)

About Galderma Japan

Galderma KK, the fully-owned Japanese arm of Galderma, was established in1996. It has been marketing the topical anti-fungal product Pekiron(R) Cream0.5% (Loceryl(R)) under a licensing agreement

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