Ipsen today announced that Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated: “I am pleased with the approval by the FDA of this new indication for Somatuline, which is a testimony to the scientific quality of those clinical results. Ipsen is now prepared to launch in the US the first antitumor therapeutic approved for the treatment of both pancreatic and gastrointestinal neuroendocrine tumors. This represents a significant step forward in the treatment of this cancer, which affects thousands of Americans. In the US, we have diligently built a robust commercial organization that will execute on the launch of Somatuline in this indication in early 2015.” Marc de Garidel concluded: “Today marks a major strategic milestone in our history, as we are now in a position to fully leverage our presence in the US.”

For more details, go to: http://www.ipsen.com/wp-content/uploads/2014/12/12-2014-corporate-PR-Approval-Somatuline-US-FINAL.pdf