Savient and Teva Launch TEV-TROPIN for Pediatric Growth Hormone Deficiency.EAST BRUNSWICK, N.J. -- 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) and Teva Pharmaceuticals Industries Ltd. (NASDAQ: TEVA) have announced the U.S. launch of TEV-TROPIN(TM) (somatropin (rDNA origin) for injection), a growth hormone growth hormone or somatotropin (sōmăt'ətrō`pən), glycoprotein hormone released by the anterior pituitary gland that is necessary for normal skeletal growth in humans (see protein). product for the treatment of children with short stature due to growth hormone deficiency growth hormone deficiency Hypopituitarism Endocrinology A condition which affects 1:4000 children; ♂:♀, 3-4:1 Etiology 70% of GHD is idiopathic and attributed to a prenatal insult, possibly due to hypothalamic dysfunction, given that GHD children . This product was clinically tested and FDA-approved for growth hormone deficiency (GHD GHD Growth Hormone Deficiency GHD Good Humanitarian Donorship GHD Good Hair Day GHD Gutteridge Haskins and Davey GHD Graduate Hall Director (university housing) GHD Global Help Desk GHD Growth Hormone Disorder ), and is manufactured by Savient using recombinant DNA recombinant DNA n. Genetically engineered DNA prepared by transplanting or splicing one or more segments of DNA into the chromosomes of an organism from a different species. Such DNA becomes part of the host's genetic makeup and is replicated. (rDNA) technology. Teva has begun offering TEV-TROPIN(TM) to pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. endocrinologists through its fully owned GATE Pharmaceuticals sales force. To maximize value to physicians and patients and to support optimal outcomes, Teva is providing a comprehensive patient support program known as Growth Solutions(SM), including a patient enrollment program and call center located within Teva Neuroscience, Inc. Growth Solutions(SM) utilizes world-class customer relationship management technology that is also currently being used to support Copaxone(R), Teva's successful multiple sclerosis drug, and its respective Shared Solutions(TM) patient support program. Patients can be enrolled in Growth Solutions(SM) by calling the toll-free number: (866) 838-8767. "We welcome any new drug that makes treatment for growth hormone deficiency more accessible for patients and their families," said Patricia Costa, Executive Director of the Human Growth Foundation. "TEV-TROPIN in concert with the Growth Solutions(SM) support program bring more choice and clarity to these families." 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 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(R) (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. for ophthalmic surgery), 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 osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. ). Products marketed by Savient's licensees are Mircette(R) (oral contraceptive), and BioLon(R) in the United States, and Bio-Tropin(TM), BioLon(R), 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. This news release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included in this report regarding the Company's strategy, expected future financial position, results of operations, cash flows, financing plans, discovery and development of products, strategic alliances, competitive position, plans and objectives of management are forward-looking statements. Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and other similar expressions help identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, the statements regarding the Company's new strategic direction and its potential effects on the Company's business are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the Company's business and the biopharmaceutical and specialty pharmaceutical industries in which the Company operates. Such risks and uncertainties include, but are not limited to, delay or failure in developing Prosaptide, Puricase and other product candidates; difficulties of expanding the Company's product portfolio through in-licensing; disruption of management and costs associated with the divestiture of the Company's operations in Israel; introduction of generic competition for Oxandrin; fluctuations in buying patterns of wholesalers; potential future returns of Oxandrin or other products; difficulties in obtaining financing; potential development of alternative technologies or more effective products by competitors; reliance on third-parties to manufacture, market and distribute many of the Company's products; economic, political and other risks associated with foreign operations; risks of maintaining protection for the Company's intellectual property; risks of an adverse determination in on-going or future intellectual property 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. ; and risks associated with stringent government regulation of the biopharmaceutical and specialty pharmaceutical industries. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the Company's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes. The Company's forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that the Company may make. The Company does not assume any obligation to update any forward-looking statements. |
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