- New Data Presented at the Movement Disorder Society Meeting New drug eases effects of Parkinson's disease
AGILECT(R) Can Have Positive Long-Term Effects on Function When Used Early in Parkinson's Disease Patients
NEW ORLEANS, March 7 /PRNewswire/ -- New long-term data suggest that, when initial monotherapy treatment with once-daily AGILECT® (rasagiline tablets) is started early in the course of Parkinson's disease (PD), positive effects on functional impairments at one year can be maintained up to 6.5 years. The data were presented today at the 9th International Congress of Parkinson's Disease and Movement Disorders.
These new data are from an open label follow-up extension of patients originally enrolled in the TEMPO trial [(TVP-1012) in Early Monotherapy for Parkinson's disease Outpatients], a 12-month, double-blind, parallel-group, randomized, delayed-start study conducted in 32 centers in the United States and Canada. TEMPO evaluated the effects of once-daily AGILECT® as initial monotherapy in early stage disease. Outcomes from the initial 12-month TEMPO study included a beneficial effect on the total UPDRS score (Parts I, II and III combined) for those treated initially with AGILECT® compared to those patients who received AGILECT® after a delayed start (placebo during the first six-month period followed by AGILECT® during the second six-month period). UPDRS is a research tool commonly used to measure a patient's ability to perform mental and motor tasks and activities of daily life.
Approximately half of the patients who received AGILECT® in the original TEMPO trial and were still in the study after two years (121 out of 266) were adequately maintained without additional dopaminergic therapy. In this long- term extension study of up to 6.5 years, the mean annual UPDRS decline for patients treated with AGILECT® only was 2 to 3 units compared with reported historical rates of 8 to 11 units in placebo-treated patients. The most commonly reported adverse events observed over this long-term treatment period were infection, accidental injury, nausea, and joint pain.
"Parkinson's disease is chronic, so demonstrating a positive effect over the course of six and a half years, in these patients, provides hope that AGILECT® (rasagiline tablets) may offer a new alternative for early-stage PD patients," according to Mark Lew, M.D., University of Southern California and participating investigator in the follow-up study. "Maintaining function is key in a patient's ability to perform activities that are important to them."
As of June 2004, a review of results for a subgroup of 177 patients taking AGILECT® over an average of 5.4 years, showed there were more positive effects on functional impairments in those treated early with once-daily AGILECT® as compared to those who were started later, as measured by total UPDRS. While the results seen with this subgroup of patients are encouraging, they may not be representative of the entire population (404 patients) who entered the original TEMPO study.
"These results help to support the long-term benefit of the use of once- daily AGILECT® as initial monotherapy in the treatment of early-stage Parkinson's disease and possibly the importance of early treatment in general," said Robert A. Hauser, M.D., University of South Florida, Tampa, and participating investigator in this follow-up study.
AGILECT® 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. A new drug application for AGILECT® for the treatment of PD was submitted to the U.S. Food and Drug Administration (FDA) Sept. 5, 2003. Indications are being sought for once-daily AGILECT® as a monotherapy in early PD and as an adjunct to levodopa in moderate-to-advanced disease.
Parkinson's disease 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.
Teva Neuroscience, Inc. and Eisai Inc. will co-promote AGILECT® (rasagiline tablets) in the United States, once approved by the FDA, as part of a long-term strategic alliance between Teva Pharmaceutical Industries Ltd. and Eisai Co., Ltd. Teva and H. Lundbeck A/S will co-promote the product in Europe, which received Marketing Authorization on February 22, 2005.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News), 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 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products in more than 30 countries. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of more than $1.7 billion (year ended March 31, 2004). Eisai focuses its efforts in four therapeutic areas: neurology, gastrointestinal disorders, oncology and acute care.
The development of rasagiline is part of a long-term alliance for co- development in Parkinson's disease and European marketing between Teva and H. Lundbeck A/S.
Rasagiline was developed cooperatively by Teva and the Technion - Israel Institute of Technology. Rasagiline was submitted for review in Canada Sept. 24, 2003, where, upon approval, it will be marketed by Teva Neuroscience, Inc.
AGILECT® (rasagiline tablets) is a registered trademark of Teva Pharmaceutical Industries Ltd.
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 of Teva Pharmaceutical Industries Ltd. 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® sales, including potential competition from the expected launch of Tysabri®/Antegren®, 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, 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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