Somatuline Depot

Treatment for Acromegaly

Update: Somatuline Depot Now FDA Approved - August 30, 2007

Tercica Reports Somatuline Autogel NDA for Acromegaly Submitted to FDA

BRISBANE, Calif., November 2, 2006 -- Tercica, Inc. today 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.

"Ipsen's submission of the NDA for Somatuline Autogel injection is an important milestone for Tercica as it moves the product closer to potential approval and commercialization in the United States," said John A. Scarlett, M.D., President and Chief Executive Officer of Tercica.

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.

In July 2006 Health Canada approved Somatuline Autogel for the long-term treatment of patients with acromegaly due to pituitary tumors who have had inadequate response to or cannot be treated with surgery and/or radiotherapy and for the relief of symptoms associated with acromegaly. Tercica expects to launch Somatuline Autogel in Canada in early 2007.

About Somatuline Autogel and Acromegaly

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.

According to epidemiology data(1), acromegaly affects approximately 15,000 people in the United States and Canada and is most commonly found in middle-aged adults. Studies estimate an all-cause mortality rate associated with acromegaly of at least twice the normal population, and a reduction in life expectancy of 5 to 10 years.

Reference:
(1) Alexander L, Clin Endocrinol 12:71-79, 1980 & Bengtsson BA, Acta Med Scan 223:327-335, 1988

Source: Tercica, Inc.

Posted: November 2006

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