PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) announced today that its partner Teijin has received manufacturing and marketing approval from the Japan’s Ministry of Health, Labour and Welfare (MHLW) for Somatuline® 60/90/120 mg 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). Somatuline® will be available in a new enhanced presentation with a pre-filled syringe that does not need reconstitution and with a retractable needle that enhances safety for caregivers.
Marc de Garidel, Chairman and Chief Executive Officer of Ipsen said:“We are delighted to announce 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 concluded: “This approval further confirms our strategy of focus and international leverage.”
About the agreements with Teijin
In 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 will record the supply sale to Teijin in its sales line.
Acromegaly is a disorder caused by the over-production of growth hormone usually by a benign tumor of the anterior pituitary gland. Acromegaly occurs in approximately 60 people per million of population. The number of patients in Japan, including latent patients, is thought to be about 10,000.
In acromegaly patients, the pituitary gland releases too much growth hormone (“GH”) into the bloodstream, the GH then triggers the liver to produce IGF-1, which in turn directly stimulates bone and tissue growth. The most common signs and symptoms of this serious condition include: enlarged hands, feet, and head, facial changes such as bulging forehead, enlarged lower jaw, tongue and lips, wider spacing between teeth, enlarged heart, liver, kidneys, spleen and other organs, joint pain and fatigue and multiple organs failure (cardiac, respiratory and diabetes). The term pituitary gigantism is used when the condition occurs in children, since it results in excess height and growth of feet and hands.
The active substance in Somatuline® and Somatuline®Autogel®is lanreotide, which inhibits the growth and secretion of several endocrine, exocrine and paracrine functions. It is particularly effective in inhibiting the secretion of growth hormone.
Somatuline® (also marketed as Somatuline® Autogel®outside the USA and Somatuline® Depot ® in the USA) is a sustained release formulation for injection containing lanreotide, a somatostatin analogue (a hormone that inhibits the release of growth hormone). Somatuline® was initially developed and continues to be used mainly in the treatment of acromegaly, a disorder caused by the overproduction of growth hormone or prolactin due to a benign tumour of the anterior pituitary gland. This product subsequently underwent further development in Europe in the treatment of symptoms associated with neuroendocrine tumours (particularly of a carcinoid type). Ipsen believes that the Somatuline® Autogel®formulation, to which it holds the patent, represents a major technological advance. As far as the Group is aware, this represents the first semisolid formulation for injection without any excipient, since the active substance itself controls the sustained release. Somatuline®Autogel® releases the active substance with no excipient other than water over a period of at least 28 days, thus requiring just one injection per month compared with the two or three injections previously necessary. This product is presented in a pre-filled syringe for easy administration. At 31 December 2011, Somatuline® and Somatuline® Autogel® were marketed in over 54 countries (including 25 in Europe and the USA) for the treatment of acromegaly and neuroendocrine tumors.
About the Teijin Group
Teijin (TSE 3401) is a technology-driven global group offering advanced solutions in the areas of sustainable transportation, information and electronics, safety and protection, environment and energy, and healthcare. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has some 150 companies and around 17,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY 854.4 billion (USD 10.7 billion) and total assets of JPY 762.1 billion (USD 9.5billion) in the fiscal year ending March 31, 2012. Please visit www.teijin.co.jp/english.
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.1 billion in 2011. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by four franchises: neurology / Dysport®, endocrinology / Somatuline®, uro-oncology / Decapeptyl® and hemophilia. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2011, R&D expenditure totaled more than €250 million, above 21% of Group sales. The Group has total worldwide staff of close to 4,500 employees. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
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