Somatuline Depot

Treatment for Acromegaly

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

FDA Accepts for Filing a New Drug Application (NDA) for Somatuline Autogel

PARIS, January 15, 2007 - Ipsen today announced the Food and Drug Administration (FDA) has accepted the filing of its NDA for Somatuline Autogel (60, 90, 120 mg) in the United States as 28-day sustained-release formulation to treat patients with acromegaly. This acceptance signifies the start of the review process of the NDA with a "prescription drug user fee act" goal date set for 30 August 2007. Subject to the approval of the drug by the FDA, Ipsen's partner Tercica will market Somatuline Autogel in the United States.

Somatuline Autogel has already received a marketing approval in Canada on 17 July 2006, and is currently being launched by Tercica under its distribution licence agreement with Ipsen, holder of the product's rights.

About Somatuline Autogel

Somatuline Autogel is an injectable sustained-release formulation containing lanreotide, a somatostatin analogue. Somatuline was initially developed and continues to be used in the treatment of acromegaly (a disorder caused by the over-production of growth hormone secondary to a benign tumour of the anterior pituitary gland) and is also approved, outside of North America, for the treatment of symptoms associated with neuroendocrine tumours (particularly of carcinoid type). Somatuline 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 pre-filled syringe for convenient administration. In acromegaly, Somatuline is used primarily when circulating levels of growth hormone remain elevated following surgery or radiotherapy, and lowers growth hormone and IGF-1 levels, thus controlling disease progression and relieving the symptoms associated with active acromegaly.

At 31 December 2005, Somatuline and Somatuline Autogel had marketing authorisations in over 50 countries (including 26 in Europe) for the treatment of acromegaly and neuroendocrine tumors and in six countries (including 2 in Europe) for the treatment of acromegaly alone.

According to epidemiology data (source: Alexander L, Clin Endocrinol 12:71-79, 1980 & Bengtsson BA, Acta Med Scan 223:327-335, 1988), 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.

Source: www.ipsen.com

Posted: January 2007

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