Somatuline® Autogel® 120 mg receives Japanese approval for a new indication for the treatment of gastro-entero-pancreatic neuroendocrine tumors

Paris (France) and Tokyo (Japan), July 3, 2017 --- Ipsen (Euronext: IPN; ADR: IPSEY) and Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business today announced that Teijin Pharma has received approval from the Japanese Ministry of Health, Labour and Welfare for Ipsen's subcutaneous drug Somatuline (lanreotide) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP NET). The drug is approved in Japan for the treatment of acromegaly and pituitary gigantism since 2012.

The request for the additional approval was filed in July 2016, based on Ipsen’s investigational, pivotal phase III randomised placebo-controlled trial (CLARINET) in 204 patients with GEP NET conducted in 14 countries, and an open-label single group multicenter Phase II trial (J-001) in 32 patients with NET that Teijin Pharma conducted in Japan. This approval establishes Somatuline as the first drug available in Japan for the treatment of pancreatic NET.

Harout Semerjian, Executive Vice-President & President, Specialty Care International & Global Franchises said: "We are pleased that Somatuline is now also available for Japanese patients suffering from gastrointestinal and pancreatic neuroendocrine tumors. In line with our commitment to serve NET patients worldwide, this is a significant step after our partner Teijin launched Somatuline for the treatment of acromegaly and pituitary gigantism in Japan in January 2013"

Akihisa Nabeshima, President of Teijin Pharma said: "It is our great pleasure to now have the capacity to provide a new therapeutic option to NET patients in Japan. We will continue to focus on drug discovery and improve the quality of life of patients by offering them new treatment options to fulfill unmet medical needs.”

About Neuroendocrine Tumors
NETs are malignant tumors arising from neuroendocrine cells. Most of the NET tumors present with metastasis and are discovered fortuitously. In some patients, excess hormones secreted from a NET can lead to severe diarrhea, peptic ulcers or hypoglycemia. While incidence rates are relatively rare, at about 3.5 gastrointestinal NET patients and 1.3 pancreatic NET patients per 100,000 people in Japan, the number of patients has been increasing year by year due to disease awareness and better diagnosis*1.
*1: Tetsuhide Ito et al J Gastroenterol (2015) 50:58-64

The primary treatment for NETs is removal by surgery, but if this is not possible as the disease is usually disseminated, or if a tumor relapses following surgery, another option is a medical treatment.

About Somatuline®
The active substance in Somatuline is lanreotide acetate, a somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine functions. It has been shown to be effective in inhibiting the secretion of GH and certain hormones secreted by the digestive system. Somatuline is marketed as Somatuline Depot within the United States and as Somatuline Autogel in other countries where it has marketing authorization. Somatuline is indicated for the treatment of acromegaly and neuroendocrine tumors in 70 countries.
 

< Product Summary >

BRAND NAME SOMATULINE® 60 mg for s.c. Injection;
SOMATULINE® 90 mg for s.c. Injection;
SOMATULINE® 120 mg for s.c. Injection
GENERIC NAME lanreotide acetate
DOSAGE FORM Sustained -release Injection (pre-filled syringe with needle)
INDICATIONS To ameliorate oversecretion of growth hormone and/or IGF-I (Somatomedin-C) as well as improvement of symptoms associate with the following diseases:

Acromegaly, Pituitary gigantism (when response to surgical therapies has not been satisfactory or surgery is difficult to be performed)

Gastroentero-pancreatic neuroendocrine tumors
DOSAGE AND ADMINISTRATION In adults, 90 mg of lanreotide is usually administered by deep subcutaneous injection at 4-week intervals for 3 months, followed by 60, 90 or 120 mg every 4 weeks. The dosage may be adjusted according to the patients’ clinical condition. In adults, 120 mg of lanreotide is usually administered by deep subcutaneous injection at 4-week intervals

※The additional indication is described in the bolded part.
The indication for Gastroentero-pancreatic NETs is approved for Somatuline 120 mg for s.c. Injection alone.


About the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. 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 170 companies and around 19,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY741.3 billion (USD 6.5 billion) and total assets of JPY 964.1 billion (USD 8.5 billion) in the fiscal year ending March 31, 2017. 

About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neurosciences and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales close to €1.6 billion in 2016, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries.  Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,100 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.

Press Contact
Teijin

Corporate Communications
Teijin Limited
+81 3 3506 4055
pr@teijin.co.jp


Ipsen

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It is subject to change without prior notice.

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