Healthcare Industry News: Somatuline
News Release - January 16, 2007
Tercica Reports Somatuline(R) Autogel(R) NDA for Acromegaly Accepted for Filing by FDASomatuline(R) Autogel(R) Now Available in Canada
BRISBANE, Calif.--(HSMN NewsFeed)--Tercica, Inc. (Nasdaq:TRCA ) today reported that its partner IPSEN (Euronext; IPN) received notice that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for Somatuline® Autogel® (60, 90, 120 mg) in the United States as a 28-day sustained-release formulation to treat patients with acromegaly. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Tercica expects the FDA will complete its review or otherwise respond to the Somatuline® Autogel® NDA by August 30, 2007.
Somatuline® Autogel® has already received a marketing approval in Canada and is currently being launched by Tercica under its distribution license agreement with Ipsen. Subject to approval by the FDA, Tercica will also market Somatuline® Autogel® in the United States.
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 tumor of the anterior pituitary gland) and is also approved, outside of North America, for the treatment of symptoms associated with neuroendocrine tumors (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 December 31, 2005, Somatuline® and Somatuline® Autogel® had marketing authorizations 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.
Ipsen is a European pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,000. The company's development strategy is based on a combination of products in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders), which are growth drivers and primary care products which contribute significantly to its research financing. This strategy is also supported by an active policy of partnerships. The location of its four R&D centers (Paris, Boston, Barcelona and London) gives the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. In 2005, Research and Development expenditure reached EUR 169 million, i.e. 20.9% of consolidated sales, which amounted to EUR 807 million in the Group's pro forma accounts set up according to the IFRS. Nearly 700 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. Ipsen's shares are traded on Segment A of Eurolist by Euronext (stock code: IPN, ISIN code: FR0010259150). Ipsen's internet website is www.Ipsen.com.
Tercica is a biopharmaceutical company committed to improving endocrine health by partnering with the endocrine community to develop and commercialize new therapeutics for short stature and other metabolic disorders. For further information on Tercica, please visit www.tercica.com.
Safe Harbor Statement
Except for the historical statements contained herein, this press release contains forward-looking statements concerning prospects and results, including statements that: (1) Tercica expects the FDA will complete its review or otherwise respond to the Somatuline® Autogel® NDA by August 30, 2007; (2) subject to approval by the FDA, Tercica will market Somatuline® Autogel® in the United States; and (3) acromegaly affects approximately 15,000 people in the United States and Canada. Because Tercica's forward-looking statements are subject to risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, that: (i) the FDA may not grant a marketing approval or grant a marketing approval covering so few patients that it is not commercially reasonable for the company to launch the product; (ii) there may be fewer patients than Tercica estimates; and (iii) the risks and uncertainties disclosed from time to time in reports filed by Tercica with the SEC, including most recently Tercica's Form 10-Q for the quarter ended September 30, 2006 filed with the SEC on November 3, 2006.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.