On July 28, 2016 Ipsen (Euronext: IPN; ADR: IPSEY) and Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, reported 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) (Press release, Ipsen, JUL 28, 2016, View Source [SID:1234514143]). The drug is currently available in Japan as a treatment for acromegaly and pituitary gigantism. Schedule your 30 min Free 1stOncology Demo! Ipsen and Teijin Pharma are confident that Somatuline will provide a beneficial treatment option for patients in Japan with neuroendocrine tumors.
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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.