JERUSALEM, Feb. 2 Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today the availability of new resources to support the recently introduced Tjet® injector system, a needle-free device designed to deliver Teva's TEV-TROPIN® [somatropin (rDNA origin) for injection] brand human growth hormone (hGH) to children who have growth failure due to inadequate secretion of normal endogenous growth hormone. The Tjet® device uses a needle-free delivery system that releases the same amount of TEV-TROPIN® as a traditional syringe in two seconds.
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To help families with a growth hormone deficiency (GHD) diagnosis, Teva has launched an updated web site (http://tevtropin.com/) that includes information specifically tailored for kids, teens and parents, and caregivers; instructional videos to help families learn about the Tjet® device; and information about Growth Solutions®, the company's comprehensive patient support program that offers training and education, as well as insurance and reimbursement assistance.
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"The Tjet® device is a great option for children with growth hormone deficiency, especially those who dislike needles," states Paul Saenger, M.D. "The families in my practice have found that the Tjet® is a kid-friendly way to administer the daily medication that their children need to help reach their normal heights."
As part of its commitment to pediatric patient care, Teva will also provide the Tjet® device and replacement supplies free of charge with all prescriptions for TEV-TROPIN® when requested by a physician.
The Tjet® device works by releasing a thin stream of TEV-TROPIN® that penetrates the stratum corneum (outermost layer skin) and is delivered into the subcutaneous (below the skin) tissue in two seconds through a tiny opening in the skin less than one third the size of a 30-gauge needle. With flexible dosing in increments of 0.05 mg, the Tjet® device delivers the prescribed dose of TEV-TROPIN® with one click of a button. The Tjet® device can be used on the back of the upper arm, the upper outer thigh, stomach, or buttocks. The Tjet® device has an eco-friendly design that means less waste compared to needle-pen devices or traditional syringe administration.
For more information about GHD and the Tjet® device, visit http://tevtropin.com/.
About Growth Hormone Deficiency
GHD affects an estimated 22,000 children in the United States. GHD is a disorder where the body produces an insufficient amount of growth hormone or none at all. Without enough growth hormone, a child may not be able to grow at an expected rate or reach his or her anticipated adult height.
About TEV-TROPIN®
TEV-TROPIN® is indicated only for the treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone (GH).
Important Safety Information for TEV-TROPIN®
Growth hormone may be used in children with confirmed Prader-Willi Syndrome only when diagnosed with GHD. Children who are severely overweight, have breathing problems while awake or asleep, and have lung infections should stop use of growth hormone and consult a physician. This may occur more in boys.
Changes in eyesight, headaches, nausea, and vomiting may occur. Frequent eye examinations should be done before and during treatment. Patients should be observed for elevated blood glucose, underactive thyroid, underactive pituitary, skin cancers, development of a limp, or complaint of hip or knee pain. Patients with rapid onset critical illness as a result of open heart or abdominal surgery, multiple accidental trauma, or rapid onset respiratory failure should not be started on TEV-TROPIN®. Patients with injury or active cancer in the brain, eye problems related to diabetes, or bones that have stopped growing should not receive recombinant growth hormone.
When TEV-TROPIN® is administered at the same site over a long period of time, damage to the tissue may result. This can be avoided by rotating the injection site.
Because TEV-TROPIN® increases growth rate, patients with a history of curvature of the spine (scoliosis) should be monitored.
TEV-TROPIN® may interfere with other drugs removed from the body by the liver and careful monitoring is advisable.
The liquid provided to mix TEV-TROPIN® should not be used in newborns because of associated toxicity. Doses of reconstituted TEV-TROPIN® greater than 1 mL are not recommended. Consult your child's physician for doses greater than 1 mL. Do not exceed the dose recommended by your child's physician.
In studies of GHD children, headaches occurred infrequently. Injection-site reactions, for instance pain or bruising, occurred in 8 of the 164 treated patients.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80% of Teva's sales are in North America and Europe.
Teva's Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act 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 our 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 risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin®, Lotrel® and Protonix®, the current economic conditions, competition from brand -name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the effects of competition on our innovative products, especially Copaxone® sales, dependence on the effectiveness of our patents and other protections for innovative products, the impact of consolidation of our distributors and customers, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, our ability to achieve expected results though our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the uncertainty surrounding the legislative and regulatory pathway for the registration and approval of biotechnology -based products, the regulatory environment and changes in the health policies and structures of various countries, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, our ability to successfully identify, consummate and integrate acquisitions, including the integration of Barr Pharmaceuticals, Inc., the potential exposure to product liability claims to the extent not covered by insurance, our exposure to fluctuations in currency, exchange and interest rates, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, our ability to enter into patent litigation settlements and the intensified scrutiny by the U.S. government, the termination or expiration of governmental programs and tax benefits, impairment of intangible assets and goodwill, environmental risks, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").
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TEV-TROPIN® and Tjet® are registered trademarks of Teva Pharmaceuticals USA.
Growth Solutions® is a registered service mark of Teva Pharmaceuticals USA.
(C) 2010, Teva Pharmaceuticals USA 8523 09852301/091903
SOURCE Teva Pharmaceutical Industries Ltd.
