FDA News

Somatuline Depot Receives FDA Marketing Approval for the Treatment of Acromegaly

(Aug 30, 2007)-- Tercica announced that its partner Ipsen (Euronext:IPN) has received notice of approval from the U.S. Food and Drug Administration (FDA) for marketing Somatuline® Depot (lanreotide) injection 60, 90 and 120 mg/ml in the United States.

Somatuline Depot is indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Somatuline Depot will be available in a pre-filled syringe eliminating any need for reconstitution and thus enabling freedom of easy administration to patients. The FDA has also designated Somatuline Depot as an orphan drug for acromegaly. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan product.

In October 2006, Ipsen granted to Tercica the development and commercialization rights for Somatuline Depot in the United States and Canada. At the same time, Ipsen acquired a 25% stake in Tercica on a non-diluted basis. According to the terms of the agreement, the FDA approval of Somatuline Depot triggers a €30 million (approximately $41 million) milestone payment that Tercica will pay to Ipsen by issuing a convertible bond (converted into Tercica common stock at a conversion price of €5.92). Tercica will simultaneously issue an additional $15 million convertible bond to Ipsen (converted into Tercica common stock at a conversion price of $7.41), which will be paid in cash to Tercica.

“We are delighted with the approval of Somatuline Depot. Somatuline Depot is the only long-acting acromegaly therapy available in a pre-filled syringe, and the only long-acting somatostatin analogue that does not require reconstitution prior to injection. Somatuline Depot provides a significant medical advance for the treatment of acromegaly by offering physicians, nurses, and patients the freedom of easy injections and ready-to-go simplicity. We expect to launch Somatuline Depot in the U.S. in approximately eight weeks,” said John A. Scarlett, M.D., Tercica’s President and Chief Executive Officer. “The approval of Somatuline Depot represents a major step in our goal of establishing Tercica as the leading U.S. endocrine and metabolic company. This will be the second market introduction of an important endocrine product made by Tercica within a two-year period. Tercica has now become a well balanced biotechnology company with two commercial products and an exciting pipeline that includes our next generation growth hormone products targeting existing billion dollar market opportunities,” added Dr. Scarlett.

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