Savient Pharmaceuticals, Inc. Initiates Phase II Clinical Study Of Puricase For Severe Gout.Business Editors/Health/Medical Writers BIOWIRE2K EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--April 7, 2004 Savient Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SVNT) announced today that it has initiated a Phase II clinical study of Puricase(R), a polyethylene glycol ("PEG") conjugate of uricase (urate oxidase), in the treatment of severe, refractory gout. The Phase II multi-center study will assess the effect of repeated intravenous administration of a range of doses and regimens of Puricase on uric acid levels, and its safety and tolerability, in patients with hyperuricemia hyperuricemia /hy·per·uri·ce·mia/ (-u?ri-se´me-ah) uricemia; an excess of uric acid in the blood.hyperurice´mic hy·per·u·ri·ce·mi·a n. An unusually high concentration of uric acid in the blood. and symptomatic severe refractory gout. Subjects selected for the study are not adequately treated by the conventional therapy, allopurinol allopurinol /al·lo·pur·i·nol/ (al?o-pur´i-nol) an isomer of hypoxanthine, capable of inhibiting xanthine oxidase and thus of reducing serum and urinary levels of uric acid; used in prophylaxis and treatment of hyperuricemia and uric acid , or are intolerant of it. No other approved therapy is currently available that adequately treats these refractory symptomatic patients. In a Phase I single intravenous dose study completed in 2003 in patients with refractory gout, Puricase was well tolerated by all patients and appeared to be safe. Elevated plasma uric acid levels were reduced to well within the normal range and considerably below levels achieved with currently available therapies. Sim Fass, Chairman and Chief Executive Officer of Savient Pharmaceuticals, Inc. stated: "Our Phase I study has demonstrated that intravenous delivery of Puricase appears to be safe and well tolerated by patients with severe refractory gout. Additionally, it has provided us with very encouraging data that confirm its ability to reduce elevated plasma uric acid levels to normal. We expect our Phase II study, investigating the effect of multiple intravenous doses of Puricase, to be completed later this year. If it confirms the safety and tolerability of Puricase, together with sustained reduction of elevated uric acid levels in this refractory population, we will follow with a Phase III study. It is our belief that Puricase could become an important niche product, by providing relief to those gout sufferers who cannot benefit from currently available therapies." Uric acid is a very poorly soluble metabolite that is excreted by the kidneys. However, if excess uric acid accumulates, it can form needle shaped crystals in the joints and tissues causing painful tophi Tophus (plural, tophi) A chalky deposit of a uric acid compound found in gout. Tophi occur most frequently around joints and in the external ear. Mentioned in: Gout , gouty arthritis, and/or gouty kidney disease. Uricase is an enzyme produced by most mammals, though not by humans, that converts uric acid into allantoin allantoin /al·lan·to·in/ (ah-lan´to-in) a crystalline substance found in allantoic fluid, fetal urine, many plants, and produced synthetically; used topically as an astringent and keratolytic. , a highly soluble and easily excreted product. Puricase is a chemically modified form of recombinant uricase, based on mammalian sequences, under development by Savient for individuals with severe gout who cannot be treated adequately by conventional therapies. Savient has received 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. Orphan Drug designation for Puricase in the treatment of gout patients for whom conventional therapy is contraindicated or has been ineffective. It is estimated that there are approximately 32,000 individuals in the United States who suffer from severe, untreatable gout. Savient licensed worldwide rights to the technology relating to Puricase from Duke University ("DUKE") of North Carolina, and Mountain View Pharmaceuticals, Inc. ("MVP (Multimedia Video Processor) A high-speed DSP chip from Texas Instruments, introduced in 1994. Officially introduced as the TMS320C80, it combines RISC technology with the functionality of four DSPs on one chip. "), a California corporation. DUKE developed the recombinant uricase enzyme and MVP designed and synthesized PEG conjugates of uricase to prolong its duration of action and enhance its safety by reducing its potential immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. . MVP and Duke have been granted U.S. and foreign patents covering the licensed technology. About Savient Pharmaceuticals, Inc. Savient Pharmaceuticals, Inc. is engaged in developing, manufacturing, and marketing pharmaceutical products that address unmet medical needs in both niche and wider markets. Products marketed by Savient's sales force in the United States are Oxandrin(R) (oxandrolone, USP USP - unique sales point ) and Delatestryl(R) (testosterone enanthate). The Company's subsidiary, Rosemont Pharmaceuticals Limited, develops, manufactures, and markets through its own sales force oral liquid formulations of prescription products for the UK pharmaceutical market. The Company's Israeli subsidiary, Bio-Technology General (Israel) Ltd., manufactures and markets in Israel Bio-Tropin(TM) (recombinant human growth hormone human growth hormone (HGH): see growth hormone. ), BioLon(TM) (sodium hyaluronate hyaluronate /hy·al·uro·nate/ (hi?ah-ldbobr´ro-nat) a salt, anion, or ester of hyaluronic acid. The sodium salt and a derivative of it are used as analgesics in the treatment of osteoarthritis of the knee. ), Bio-Hep-B(R) (hepatitis B vaccine hepatitis B vaccine n. Abbr. HB A vaccine prepared from the inactivated surface antigen of the hepatitis B virus and used to immunize against hepatitis B. ), and Arthrease(TM) (sodium hyaluronate for osteoarthritis). Products marketed by Savient's licensees are Mircette(R) (oral contraceptive), and BioLon(TM) in the United States, and Bio-Tropin(TM), BioLon(TM), Bio-Hep-B(R), Silkis(R) (vitamin D derivative), and recombinant human insulin Noun 1. recombinant human insulin - a form of insulin (trade name Humulin) made from recombinant DNA that is identical to human insulin; used to treat diabetics who are allergic to preparations made from beef or pork insulin Humulin , in international markets. Savient's news releases and other information are available on the Company's website at www.savientpharma.com. Arthrease is a trademark of DePuy Orthopaedics, Inc., except in Israel, where it is owned by Bio-Technology General (Israel) Ltd., Savient's wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. ; Mircette is a registered trademark of Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. , Inc.; Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.; Silkis is a registered trademark of Galderma S.A. Statements in this news release concerning the Company's business outlook or future economic performance, anticipated profitability, revenues, expenses or other financial items; and statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements" as that term is defined under the Federal Securities Laws. Forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to, the timing of the introduction of a generic version of Oxandrin, changes and delays in product development plans and schedules, changes and delays in product approval and introduction, customer acceptance of new products, development, introduction, or consumer acceptance of competing products, changes in pricing or other actions by competitors, patents owned or licensed by the Company and its competitors, changes in healthcare reimbursement, risk of operations in Israel, risk of product or other litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. liability, governmental regulation, dependence on third parties to manufacture products and commercialize products, and general economic conditions, as well as other risks detailed in the Company's filings with the Securities and Exchange Commission. |
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