Galderma Pharma S.A. News

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

LAUSANNE, Switzerland, July 16 PRNewswire — 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(R) 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(R) 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.(1) 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(2a) a demonstrated that treatment with Differin(R) 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.(2b) A 12-month long-term safety study of more than 400 patients(3) a showed that the treatment was safe and remained effective with long-term use.(3b)

"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 will co-promote Differin(R) Gel 0.1% with their respective sales forces and Shionogi will have sales and distribution rights for the product for a period of eight years. Commercialization will begin once the product is listed on the National Health Insurance reimbursement list, a process that is expected to be complete by autumn 2008.

"The decision by Japan's Ministry of Health, Labor and Welfare is excellent news for patients and physicians in Japan, who will now have access to a first-in-class topical retinoid for the treatment of acne," said Humberto C. Antunes, Chief Executive Officer of Galderma International. "We undertook the largest acne clinical program ever in Japan, and knew it would be a long journey to approval. This project underscores Galderma's commitment to dermatology in all parts of the world and dedication to improving the quality of life of acne patients in Japan."

Differin(R) Gel 0.1% is a naphthoic acid derivative with retinoid-like activities.(2c) Differin(R) will be the first product to be launched in Japan belonging to this class of treatment. Differin(R) appears to normalize the differentiation of a type of skin cell linked to acne, resulting in fewer non-inflammatory and inflammatory lesions.(2c)

About Acne

Acne vulgaris is one of the most widely experienced chronic skin diseases worldwide. In recent years, research has led to a greater understanding of the pathogenesis of the disease.(4) The disorder begins with the onset of puberty 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 can be 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 in 1996. It has been marketing the topical anti-fungal product Pekiron(R) Cream 0.5% (Loceryl(R)) under a licensing agreement with Kyorin Pharmaceutical since 2002. With the introduction of Differin(R) Gel 0.1% in Japan, Galderma KK, aims to provide comprehensive scientific information to prescribers and medical institutions, with the goal of improving treatment outcomes, as well as the quality of life of Japanese acne patients.

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 is present in 65 countries with over 1000 medical sales representatives and is committed to improving the health of skin with an extensive line of products to treat a range of dermatological conditions including: acne, rosacea, fungal nail infections, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancers and medical solutions for skin senescence. With a main research and development center in Sophia Antipolis, France, Galderma has one of the largest R&D facilities devoted exclusively to dermatology. Leading dermatology brands include Differin(R), MetroGel(R) 1%/Rozex(R), Oracea(R), Clobex(R), Tri-Luma(R), Loceryl(R) and Cetaphil(R). Recently launched products include Pliaglis(R), a topical anesthetic for dermatologic procedures in the United States, Epiduo(R), an innovative combination product for the treatment of acne in Europe and Argentina, and Dysport(R), an injectable muscle relaxant for use in aesthetic medicine and dermatological indications in Brazil and Argentina. The Company's international Web site is http://www.galderma.com.

Differin, MetroGel, Oracea, Rozex, Clobex, Tri-Luma, Loceryl, Cetaphil and Epiduo are trademarks of Galderma.

Pliaglis is a trademark of Zars Pharma Inc. Dysport is a trademark of Ipsen Ltd. (1) Data on file. (2) Kawashima M, Harada S, Loesche C and Miyachi Y. Adapalene gel 0.1% is effective and safe for Japanese patients with acne vulgaris: A randomized, multicenter, investigator-blinded, controlled study. Journal of Dermatological Science. 2008; 49:241-248. (3) Kawashima M, Harada S, Andres P and Miyachi Y. One-Year Efficacy and Safety of Adapalene Gel 0.1% gel in Japanese Patients with Acne Vulgaris. Skin Research. 2007; 6:504-512. (4) Gollnick H, Cunliffe WJ, Berson D et al. Management of Acne: A Report From a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2003; 49(1):S1-S37. (5) Why Do I Get Acne? Nemours Foundation. http://www.kidshealth.org/teen/your_body/skin_stuff/acne.html.

SOURCE Galderma Pharma S.A.

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