Healthcare Industry News: Somatuline
News Release - January 15, 2007
FDA Accepts for Filing a New Drug Application (NDA) for Somatuline(R) Autogel(R)Somatuline(R) Autogel(R) now available in Canada
PARIS--(HSMN NewsFeed)--Ipsen (Euronext: FR0010259150) (Paris:IPN ) 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.
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
The forward-looking statements and targets contained herein are based on Ipsen's management's current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein.
Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its information documents filed with the French Autorite des marches financiers.
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.
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