Ipsen (Euronext : IPN ; ADR : IPSEY) and Teijin Pharma Limited, group company of Teijin in charge of the Healthcare business, today announced that Teijin Pharma has obtained the japanese Ministry of Health, Labour and welfare, the approval for Somatuline® (lanréotide) as a subcutaneous injection in the treatment of neuroendocrine tumors gastro-entero-pancreatic (NET-GEP). The drug is approved since 2012 in Japan for the treatment of acromegaly and gigantism pituitary.
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The application for authorisation of the new indication was filed in July 2016, on the basis of the pivotal study phase III, randomized, placebo-controlled study (CLARINET), conducted on 204 patients with TNE-GEP in 14 countries, and an open-label, multicenter phase II, to a treatment arm (J-001) conducted on 32 patients with NETS and conducted by Teijin Pharma in Japan. This permission is of Somatuline® is the first drug available in Japan for the treatment of pancreatic neuroendocrine tumors.
Harout Semerjian, Executive Vice President and President, Medical, specialty and international Franchises global said : “We are pleased that Somatuline® is now available for japanese patients with neuroendocrine tumors gastro-entero-pancreatic. This authorization is part of our commitment to help patients with NETS in the world and is an important step, after the launch in January 2013 Somatuline® by our partner, Teijin, in the treatment of acromegaly and gigantism pituitary. ”
Akihisa Nabeshima, President of Teijin Pharma said : “We are very pleased to have managed to propose to NETS patients a new therapeutic option in Japan. We continue to focus on drug discovery and to improve the quality of life of patients by providing new therapeutic options meeting a medical need. ”
About neuroendocrine tumors (NET)
NETS are tumors developing at the expense of neuroendocrine cells. Most of the NETS are accompanied by metastases, and are discovered incidentally. In some patients with NETS, an excess hormone secretion can cause severe diarrhoea, peptic ulcers or diabetes. If the incidence rates are relatively low (approximately 3.5 patients with PATIENTS with gastrointestinal and 1.3 in patients with NETS of pancreatic for 100 000 people in Japan), the number of patients is increasing year by year due to a heightened awareness of the disease and improve its diagnosis.[1] The main treatment for PATIENTS is the removal by surgery. If the operation is impossible because of the spread common disease, or a recurrence of the tumor after surgical removal, medical treatment is possible.
About Somatuline®
The active ingredient of Somatuline® acetate lanréotide, is an analogue of somatostatin which inhibits the secretion of several endocrine, exocrine and paracrine. It has proven to be effective to inhibit the secretion of growth hormone and certain hormones secreted by the digestive system. Somatuline® is marketed as Somatuline® Depot® in the United States and under the name of Somatuline® Autogel® in other countries where it has an authorization for placing on the market. Somatuline® is indicated for the treatment of acromegaly and neuroendocrine tumours in 70 countries.
Sources :
[1] Tetsuhide Ito et al J Gastroenterol (2015) 50:58-64
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