Tercica Reports Somatuline(R) Autogel(R) NDA for Acromegaly Accepted for Filing by FDA.Somatuline[R] Autogel[R] Now Available in Canada BRISBANE, Calif. -- Tercica, Inc. (Nasdaq:TRCA TRCA Toronto and Region Conservation Authority TRCA Trademark Remedy Clarification Act TRCA Terminal Radar Control Area (FAA) TRCA Teddy Roosevelt Conservation Alliance ) today reported that its partner IPSEN (Euronext; IPN) received notice that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has accepted the filing of its New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Somatuline[R] Autogel[R] (60, 90, 120 mg) in the United States as a 28-day sustained-release formulation to treat patients with acromegaly acromegaly (ăk'rōmĕg`əlē), adult endocrine disorder resulting from hypersecretion of growth hormone produced by the pituitary gland. . Pursuant to Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. (PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) ) guidelines, Tercica expects the FDA will complete its review or otherwise respond to the Somatuline[R] Autogel[R] NDA by August 30, 2007. Somatuline[R] Autogel[R] 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[R] Autogel[R] in the United States. About Somatuline[R] Autogel[R] Somatuline[R] Autogel[R] is an injectable sustained-release formulation containing lanreotide, a somatostatin Somatostatin A naturally occurring regulatory peptide that carries out numerous functions in the human body, including the inhibition of growth hormone secretion from the anterior pituitary gland. analogue. Somatuline[R] 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 Noun 1. anterior pituitary gland - the anterior lobe of the pituitary body; primarily glandular in nature adenohypophysis, anterior pituitary ductless gland, endocrine gland, endocrine - any of the glands of the endocrine system that secrete hormones ) and is also approved, outside of North America, for the treatment of symptoms associated with neuroendocrine tumors (particularly of carcinoid carcinoid /car·ci·noid/ (kahr´si-noid) a yellow circumscribed tumor arising from enterochromaffin cells, usually in the gastrointestinal tract; the term is sometimes used to refer specifically to the gastrointestinal tumor type). Somatuline[R] Autogel[R] formulation does not contain any excipient excipient /ex·cip·i·ent/ (ek-sip´e-int) any more or less inert substance added to a drug to give suitable consistency or form to the drug; a vehicle. ex·cip·i·ent n. 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[R] 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[R] and Somatuline[R] Autogel[R] 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. About Ipsen 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 EUR In currencies, this is the abbreviation for the Euro. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 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 IFRS International Financial Reporting Standard(s) IFRS Inter Frame Relay Service IFRS Indiana Facilities Registry System . 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 Isin (ĭs`ĭn), capital of an ancient Semitic kingdom of N Babylonia. The city became important after the third dynasty of Ur fell to the Elamites and the Amorites (c.2025 B.C.). The phase from c.2025–c.1763 B.C. code: FR0010259150). Ipsen's internet website is www.Ipsen.com. About Tercica 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[R] Autogel[R] NDA by August 30, 2007; (2) subject to approval by the FDA, Tercica will market Somatuline[R] Autogel[R] 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. |
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