Teva and Savient Launch TEV-TROPIN for Pediatric Growth Hormone Deficiency.JERUSALEM -- Teva Pharmaceuticals Industries Ltd. (Nasdaq: TEVA) and Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) 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 Short stature refers to a height of a human being which is below expected. Shortness is a vague term without a precise definition and with significant relativity to context. 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(TM) in concert with the Growth Solutions(SM) support program bring more choice and clarity to these families." Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and Europe. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement under the U. S. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products (so called "authorized generics") or successfully extend the exclusivity period of their branded products, the effects of competition on Copaxone(R) sales, including potential competition from the launch of Tysabri(R) Teva's ability to rapidly integrate the operations of acquired businesses, including its acquisition of Sicor Inc., regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to completion of appellate 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. , including that relating to Neurontin, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. |
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