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DEVELOPMENT PROGRAMS

Somatuline® Autogel® and Somatuline® Depot

Ipsen is pursuing the following life cycle management developments for Somatuline® Autogel®:

• a phase III clinical trial with Somatuline® Autogel® for the treatment of non functioning neuroendocrine tumors is in progress in Europe and the US;
• additional phase III clinical trials for the treatment of functioning neuroendocrine tumor symptoms in order to register Somatuline® Depot, which is the equivalent of Somatuline® Autogel® in the US, were launched in 2009;
• in March 2011, the FDA approved extending the dosage interval for six to eight weeks for acromegaly patients who are controlled by Somatuline®;
• in Japan, the Group’s partner Teijin submitted a Marketing Authorization Application (MAA) for the treatment of acromegaly. ites are ready in North America. The FDA has requested additional information on product stability before beginning clinical trials in the US.