Supplemental Application Filed for Somatuline® in Japan for Additional Indication of Neuroendocrine Tumors [Teijin Pharma] (PDF:108KB)

Ipsen and Teijin Pharma are confident that Somatuline® will provide a beneficial treatment option for patients in Japan with neuroendocrine tumors.

The application is supported by CLARINET®, Ipsen's investigational, Phase III randomized, double-blind, placebo-controlled study which assessed the antiproliferative effects of Somatuline® 120mg in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) which was conducted across 14 countries in Europe and the USA. Treatment with Somatuline® 120mg achieved statistically significant prolongation of progression free survival over placebo in patients with GEP-NETs. The safety profile observed in the study is consistent with the known safety profile of Somatuline®. CLARINET® has been the basis of the approval of an indication for the treatment of GEP-NETs in more than 40 countries, including the US and EU countries. The results complement the effects of Somatuline® on existing indications relating to reduction of symptoms associated with NETs. The supplemental application submitted to the Pharmaceuticals and Medical Devices Agency is also based on results of the J-001 Phase II trial for NETs that Teijin Pharma has conducted in Japan.

About Neuroendocrine Tumors (NETs)

Neuroendocrine cells, which release hormones, are widely distributed throughout the human body. NETs are rare, slow growing cancers that can arise anywhere in the body, but most commonly occur in the gastrointestinal tract, lung or pancreas. NETs are often diagnosed at a late stage because the symptoms, if any, lack specificity. In some patients, hormones secreted from NETs can cause problems, such as abdominal pain, flushing, diarrhea or pulmonary symptoms, such as wheezing. NETs can spread to other organs of the body and can cause severe co-morbidities and also significantly decrease

life expectancy.

The first choice of NET treatment is removal by surgery, but if this is not possible, or if a tumor returns following surgery, another option is treatment with drugs to inhibit tumor growth and/or reduce the associated symptoms. Currently there are limitations in the types of NET patients who can be treated, depending on the location and the grading of the primary tumor, so there is an unmet medical need for new medicines that can be prescribed for a wider variety of NET patients.

Ipsen is a global specialty-driven biotechnological group with total sales exceeding €1.4 billion in 2015. Ipsen sells more than 20 drugs in more than 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its fields of expertise cover oncology, neurosciences and endocrinology. Ipsen's commitment to oncology is exemplified through its growing portfolio of key therapies improving the care of patients. Ipsen also has a significant presence in primary care. 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, located in the heart of the leading biotechnological and life sciences hubs (Les Ulis/Paris-Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2015, R&D expenditure totaled close to €193 million. The Group has more than 4,600 employees worldwide. 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.

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 16,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY790.7 billion (USD 7.4 billion) and total assets of JPY 823.4 billion (USD 7.7 billion) in the fiscal year ending March 31, 2016.

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