Supplemental Application Filed for Somatuline® in Japan for Additional Indication of Neuroendocrine Tumors
Ipsen and Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, today announced that Teijin Pharma has filed a supplemental application with Pharmaceuticals and Medical Devices Agency to use Ipsen’s subcutaneous drug Somatuline® (lanreotide) for the treatment of neuroendocrine tumors (NETs). The drug is currently available in Japan as a treatment for acromegaly and pituitary gigantism.
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®, an 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® 120 mg 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 gastroenteropancreatic NETs (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
Neuroendocrine cells, which release hormones, are widely distributed throughout the human body. Neuroendocrine tumors (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.
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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