Drug Pipeline Series: Submissions, Oct 31 - Nov 6, 2006

Tercica Reports Somatuline® Autogel® NDA for Acromegaly Submitted to FDA


Tercica, Inc. reported that earlier this week its partner IPSEN submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Somatuline® Autogel® (lanreotide acetate) injection 60, 90 and 120 mg to treat patients with acromegaly. Tercica licensed from Ipsen the rights to develop and market Somatuline® Autogel® in the United States and Canada in a transaction that closed on October 13, 2006.
The FDA will determine within 60 days whether the submission will be accepted for filing.
As of December 31, 2005, Somatuline® and Somatuline® Autogel® had marketing authorizations in over 50 countries for the treatment of acromegaly and neuroendocrine tumors. The product is supplied in pre-filled syringes to be injected subcutaneously for easier administration than other long acting somatostatin analogues.

Somatuline® Autogel® is an injectable sustained-release formulation containing lanreotide, a somatostatin analogue. Somatuline® was initially developed in Europe for the treatment of acromegaly (a disorder caused by the over-production of growth hormone secondary to a benign tumor of the anterior pituitary gland) and, in most European countries, is also approved for the treatment of symptoms associated with neuroendocrine tumors. The Somatuline® Autogel® formulation requires no excipient other than water and releases lanreotide over a period of at least 28 days and up to 56 days. The product is conditioned in a pre-filled syringe for easier administration than other long-acting somatostatin analogue. In acromegaly, Somatuline® is used primarily when circulating levels of growth hormone remain high despite surgery or radiotherapy, and through its inhibitory effects, Somatuline® lowers growth hormone and IGF-1 levels, thus controlling disease progression and relieving the symptoms associated with active disease.