Galderma gains approval for acne drug in Japan

Switzerland's Galderma Pharma, a specialty pharmaceutical company focused on dermatology, says that Japan's Ministry of Health, Labor and Welfare has approved Differin (adapalene) Gel 0.1% for acne vulgaris.

A 12-week study of the treatment in 200 Japanese patients demonstrated 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, says the firm. A further 12-month long-term safety study of more than 400 patients was also completed.

Galderma and local partner Shionogi will co-promote the product with their respective sales forces and the latter will have sales and distribution rights 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 the fall.