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Teva Introduces New Thinner 29-Gauge Needle for COPAXONE Pre-Filled Syringe


Published on 2008-12-23 06:12:18, Last Modified on 2008-12-23 06:13:58 - Market Wire
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KANSAS CITY, Mo.--([ BUSINESS WIRE ])--Teva (NASDAQ:TEVA) today announced the launch of a new, thinner, 29-gauge pre-filled syringe for its multiple sclerosis (MS) treatment, COPAXONE® (glatiramer acetate injection). A recent survey of 562 MS patients found the new thinner needle was significantly preferred by 77 percent of patients over the previous 27-gauge needle.

"I used to hesitate before administering my daily injection because of slight discomfort experienced in the past," said Stacia D., COPAXONE® 29-gauge needle patient. "With the new 29-gauge needle, I immediately noticed less discomfort with each injection, and I no longer hesitate about taking my medicine."

The survey also found that approximately two out of three (66 percent) participants experienced less pain while using the thinner needle and almost half of the participants (49 percent) had a better experience dealing with injection-site reactions.

"The thinner, 29-gauge needle further demonstrates Teva's commitment to continued research and development of COPAXONE® to help provide treatment benefits over the long term," said Thomas Smith, M.D., Vice President, Medical Affairs, Teva Neuroscience. "In addition to helping improve patients' injection experiences by potentially lessening pain and reactions, the new needle may help to ensure adherence with treatment that has been shown to significantly improve patient outcomes."

Teva encourages all patients, both new and experienced, to contact Shared Solutions® to speak to an MS-certified nurse who can answer questions and discuss injection techniques that may help make taking treatment more manageable. For more information, please call 1-800-887-8100 or visit [ www.sharedsolutions.com ].

About the Study

562 study participants were questioned on overall preference and were asked to compare their experience with the thinner 29-gauge needle with their past experience with the 27-gauge needle when it came to pain and injection-site reactions (redness, itching, raised or swollen skin, warm to touch, or a lump) at 4 to 30 (mean of 21) days of use. The primary endpoint was needle performance; the secondary endpoints were pain, injection-site reactions and overall performance. Ninety-nine percent of study participants reported no performance issues with the new needle.

About COPAXONE®

COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS.

The most common side effects of COPAXONE® are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® (glatiramer acetate injection) is now approved in 52 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.

See additional important information at [ http://www.copaxone.com/pi/index.html ]or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

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 percent of Teva's sales are in North America and Europe.

About Teva Neuroscience

Teva Neuroscience is dedicated to investigating, developing and marketing ground-breaking products and technologies, with emphasis on cutting-edge treatments for patients who are living with neurological conditions, including MS and Parkinson's disease (PD). Therapies developed by Teva Neuroscience include COPAXONE® for relapsing-remitting multiple sclerosis and AZILECT® (rasagiline tablets) for the treatment of PD.

Teva Neuroscience's suite of innovative products continues to demonstrate the company's commitment to fulfilling unmet medical needs and has helped the company evolve into a global leader in RRMS. Teva Neuroscience is a North American division of Teva Pharmaceutical Industries Ltd., the world's largest generic drug company. Teva Neuroscience is proud of the role it plays in providing effective treatment options to patients worldwide. For more information, please visit [ www.tevaneuro.com ] or [ www.tevaclinicaltrials.com ].

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, 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 impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra® , Neurontin®, Lotrel® and Protonix®, the effects of competition on our innovative products, especially Copaxone® sales, 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 Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, our ability to successfully identify, consummate and integrate acquisitions, including the pending acquisition of Barr Pharmaceuticals Inc., potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, 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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