Healthcare Industry News: Somatuline
News Release - November 2, 2006
Tercica Reports Somatuline(R) Autogel(R) NDA for Acromegaly Submitted to FDABRISBANE, Calif.--(HSMN NewsFeed)--Tercica, Inc. (NASDAQ:TRCA ) today reported that earlier this week its partner IPSEN (Paris:IPN ) 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.
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, including statements that: Ipsen's submission of the NDA for Somatuline® Autogel® moves the product closer to potential approval and commercialization in the United States; and the FDA will determine within 60 days whether the submission will be accepted for filing. 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, the following risks and uncertainties: (i) Somatuline® Autogel® might never achieve FDA approval for the targeted indication, or any indication, in the United States on a timely basis, or at all; (ii) the FDA may not meet its 60-day submission acceptance target; 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 June 30, 2006 filed with the SEC on August 9, 2006. Tercica disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
(1) source: (Alexander L, Clin Endocrinol 12:71-79, 1980 & Bengtsson BA, Acta Med Scan 223:327-335, 1988)
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