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Teijin gains manufacturing, marketing approval for Somatuline in Japan

Teijin has received manufacturing and marketing approval from the Japan's Ministry of Health, Labour and Welfare for Somatuline 60/90/120mg for s.c. injection (lanreotide acetate).

In Japan, Somatuline is indicated for the treatment of growth hormone and IGF-I (somatomedin-C) hypersecretion and related symptoms in acromegaly and pituitary gigantism (when response to surgical therapies is not satisfactory or surgical therapies are difficult to perform).

The company makes Somatuline available in a new enhanced presentation with a pre-filled syringe which do not require reconstitution and with a retractable needle that enhances safety for caregivers.

Under the framework of the successive agreements signed between Teijin and Ipsen, Teijin is entitled to develop and commercialize Somatuline in Japan and Ipsen will manufacture and supply the finished product to Teijin.

Ipsen chairman and chief executive officer Marc de Garidel said that Somatuline will soon be available in Japan.

"Somatuline becomes the first Ipsen’s global drug with sales in Europe, the USA and soon Japan. We are confident that our partner Teijin will successfully bring this effective and convenient treatment to the Japanese patients," Marc de Garidel added.