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Galderma Announces Approval of Epiduo Gel for the Treatment of Acne in Japan

Galderma Pharma S.A. (”Galderma” Headquarters: Lausanne, Switzerland, CEO: Stuart Raetzman), a global leader focused on medical solutions in skin health, today announced that Japan’s Ministry of Health, Labor and Welfare has approved Epiduo, a novel topical treatment for acne vulgaris in Japan.

Since its first marketing authorization in 2007, Epiduo Gel has now been approved in over 60 countries around the world for the treatment of acne vulgaris, and is the most prescribed topical acne medication in the world.

‘As a global leader in dermatology, Galderma is committed to meeting the needs of patients by providing medical solutions for physicians all around the world. This approval of Epiduo by the Japanese Health Authorities coupled with our strategic alliance with Maruho allow us to meet a key strategic objective: enable access to Epiduo for Japanese patients’, said Stuart Raetzman, Chief Executive Officer of Galderma Pharma S.A.

Epiduo is a fixed-dose drug combination formulated as a gel containing 0.1% adapalene and 2.5% benzoyl peroxide to be applied once per day. This formulation provides patients a single solution containing two agents targeting different physiopathological events of acne.

The approval of Epiduo in Japan was supported by both international and Japanese clinical data. In two foreign Phase 3 studies involving a total of 2185 patients, Epiduo applied once daily for 12 weeks was demonstrated to be more effective than its monads. In addition, the results indicated a potentiation of the therapeutic activities of these substances when used in the Epiduo gel fixed-dose combination. The efficacy and safety of Epiduo in Japanese patients was confirmed in one 12-week study (417 patients) and a long-term study (436 patients) which showed that the efficacy of Epiduo was maintained over 12 months. Epiduo is a key innovation in the treatment of acne, and undoubtedly expands the range of treatment options for acne vulgaris sufferers in Japan.

Earlier this year, Maruho and Galderma announced a strategic alliance focused on the development and commercializ ation of prescription drugs for dermatology in Japan, including therapies in the fields of acne and rosacea. Under this alliance, Maruho will market Epiduo in Japan. 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 2016.

About Galderma

Dating back to 1961, Galderma is now present in 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care professionals around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven treatment options for the skin, hair and nails.

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Yvan Deurbroeck, Mobile phone +41792543824
Global Vice President Communications



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