IPSEN SUBMITS APPLICATION FOR ACROMEGALY TREATMENT

Ipsen has submitted a new drug application (NDA) to the FDA for Somatuline Autogel (60, 90 and 120 mg) in the United States as 28-day sustained-release formulation to treat patients with acromegaly, a disorder caused by the over-production of growth hormone secondary to a benign tumor of the anterior pituitary gland. Subject to the approval of the drug by the FDA, Ipsen's partner Tercica will market the drug in the United States.

Somatuline Autogel received approval in Canada in July 2006 and is being marketed there by Tercica under its distribution license agreement with Ipsen.

Somatuline Autogel is an injectable sustained-release formulation containing lanreotide, a somatostatin analogue. Somatuline was initially developed for the treatment of acromegaly and is also approved, outside of North America, for the treatment of symptoms associated with neuroendocrine tumors.

The Autogel formulation does not contain any excipient other than water and releases lanreotide over a period of at least 28 days. The product is conditioned in a prefilled syringe for convenient administration. In acromegaly, Somatuline is used primarily when circulating levels of growth hormone remain elevated following surgery or radiotherapy, for it lowers growth hormone and IGF-1 levels and controls disease progression.