JERUSALEM, Dec. 1 /PRNewswire-FirstCall/ -- The largest clinical study to investigate whether or not a drug can slow the progression of Parkinson’s disease (PD) has enrolled its first patients in Europe and the United States. The study, Attenuation of Disease progression with AGILECT/AZILECT(R) Once- daily (ADAGIO), will evaluate approximately 1,100 recently-diagnosed PD patients worldwide.
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PD has continued to challenge researchers as the chronic, progressive condition leads to disability and reduces the quality of patients’ lives. Current therapies help improve PD symptoms, but none has been shown to slow, halt, or reverse the progression of the disease.
The study will compare newly-diagnosed patients started immediately on AGILECT(R) (rasagiline tablets) to others whose use of AGILECT(R) therapy is delayed by nine months. “If AGILECT(R) can slow progression of PD, we will expect to see the UPDRS scores of those treated early with AGILECT(R) to be better than those who were switched to AGILECT(R) after a delayed start,” said Dr. Warren Olanow, professor and chairman of the Department of Neurology at Mount Sinai School of Medicine. “If AGILECT(R) can modify the course of PD, those treated early with AGILECT(R) should continue to do better than those whose study treatment began with placebo before being switched to AGILECT(R).” The Unified Parkinson’s Disease Rating Scale (UPDRS) is a commonly used research tool to measure a patient’s ability to perform mental and motor tasks and activities of daily life.
Teva Pharmaceutical Industries Ltd. is conducting this study in about 135 sites globally, including 52 in the United States. Interested patients should call 1-866-550-0614 to see if they are eligible to participate.
The most common side effects seen in clinical trials with AGILECT(R) alone are flu syndrome, joint pain, depression, and indigestion.
AGILECT(R) is a novel, potent, second-generation, selective, irreversible monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a substance in the brain needed to facilitate movement. AZILECT(R) has been approved by the EMEA for marketing in Europe since February 22, 2005. A new drug application for AGILECT(R) for the treatment of PD was submitted to the US Food and Drug Administration (FDA) Sept. 5, 2003. Teva has received approvable letters from FDA and is continuing to work with FDA to resolve the outstanding issues. Indications are being sought for once-daily AGILECT(R) (rasagiline tablets) as monotherapy in early PD and as an adjunct to levodopa in moderate-to-advanced disease.
Parkinson’s disease (PD) is a degenerative disorder of the brain. Symptoms can include tremor, stiffness, slowness of movement, and impaired balance. An estimated one million Americans have PD, which usually affects people over the age of 50. It is estimated that four million people worldwide have PD.
Teva Pharmaceutical Industries Ltd. , headquartered in Israel, is among the top 20 pharmaceutical companies in the world. Close to 90 percent of Teva’s sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. For more information please visit http://www.tevapharm.com .
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the beliefs and expectations of Teva’s 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 whether and when the proposed acquisition with Ivax Corporation will be consummated and the terms of any conditions imposed in connection with such closing, the terms and conditions of the financing utilized by Teva for the Ivax acquisition, Teva’s ability to rapidly integrate Ivax’s operations and achieve expected synergies, 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 under generic trade dress and at generic prices (so called “authorized generics”) or seek to delay the introduction of generic products, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final court decision, including that relating to the generic version of Neurontin(R), the effects of competition on Copaxone(R) 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 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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CONTACT: Kevin C. Mannix of Teva North America, +1-215-591-8912
Web site: http://www.tevapharm.com/
