Ipsen seeks marketing authorization from FDA for Somatuline Depot 120mg injection

Jul 2 2014

Ipsen Biopharmaceuticals, Inc., the U.S. affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Somatuline^® Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 

In the European Union, Ipsen has submitted national marketing authorization variations for Somatuline^® Autogel^® 120mg injection to the drug regulatory authorities in 25 countries.

Following EU and U.S. submissions, Ipsen intends to implement worldwide submission roll-out.

Regulatory submission is supported by the results of the CLARINET^® Phase III study, which demonstrated the antiproliferative effect of Somatuline^® in the treatment of patients with GEP-NETs. The data from CLARINET^® showed that investigational treatment with Somatuline^® substantially prolonged time to disease progression or death versus placebo (hazard ratio 0.47, p=0.0002). Safety data generated from the CLARINET^® study were consistent with the known safety profile of Somatuline^®.

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated:

There are significant unmet medical needs among GEP-NET patients and Ipsen is committed to help address them. The submission of supplemental marketing authorization applications in the U.S. and variations in Europe for Somatuline^® is evidence of our commitment to targeted oncology, and we are pleased to be able to submit them in our planned timeframe.

The data from CLARINET^® is purely investigational, as Somatuline® is not authorized for the indication of antiproliferative treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in any market. In many countries where it is marketed as Somatuline^® Autogel®, Somatuline^® is approved for treatment of acromegaly and for the symptoms associated with neuroendocrine tumors, which can include the treatment of GEP-NET patients experiencing symptoms from carcinoid syndrome, and Somatuline^® is approved in many countries for the treatment of acromegaly. Somatuline^® Depot is approved in the U.S. for the treatment of acromegaly but not for the treatment of GEP-NETs or the symptoms thereof.