• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Study Showed AGILECT(R) Improved Motor Fluctuations and Parkinson's Disease Symptoms in Levodopa-Treated Patients

Posted on: Monday, 14 February 2005, 18:00 CST

KANSAS CITY, Mo. and TEANECK, N.J., Feb. 14 /PRNewswire-FirstCall/ -- Patients with moderate-to-advanced Parkinson's disease (PD) experiencing motor complications who added once-daily AGILECT(R) (rasagiline tablets) to their treatment with optimized levodopa with or without stable doses of other anti- PD medications experienced a significant improvement in their PD symptoms and a significant reduction in "off" time* according to the "PRESTO" study published in the February issue of Archives of Neurology. AGILECT(R) was dosed once-daily and required no titration.

"Results from this study show benefits of rasagiline compared with placebo in moderate-to-advanced levodopa-treated PD patients experiencing motor complications. During disease progression and after months or years of levodopa therapy, these patients commonly experience motor complications, such as unpredictable fluctuations between 'on' and 'off' time," said Ira Shoulson, M.D., professor of neurology at the University of Rochester School of Medicine and principal investigator of the Parkinson Study Group (PSG), the organization that conducted the "PRESTO" trial. "This study showed that rasagiline demonstrated significant benefit in reducing 'off' time, increasing 'on' time, and improving features of Parkinson's disease."

The multicenter, randomized, placebo-controlled, double-blind, parallel group "Parkinson's Rasagiline: Efficacy and Safety in the Treatment of 'Off'" (PRESTO) study included 472 PD patients who were experiencing at least 2.5 hours of daily "off" time despite optimized treatment with levodopa with or without stable doses of other anti-PD medications at 57 PSG sites in the United States and Canada.

Many patients enrolled were treated, in addition to levodopa, with dopamine agonists, entacapone and/or anticholinergic medications. Patients received 1 mg or 0.5 mg AGILECT(R) (rasagiline tablets) or placebo once daily.

The average reduction in "off" time among patients using AGILECT(R) was 1.85 hours daily for the 1 mg group and 1.41 hours daily in the 0.5 mg group, while placebo provided a reduction of 0.91 hours daily.

Additionally, AGILECT(R) significantly improved motor function during "on" time (time when medication effectively manages symptoms of PD) and activities of daily living during "off" state based on the Unified Parkinson's Disease Rating Scale (UPDRS). The UPDRS is a research tool commonly used to measure a PD patient's ability to perform motor and mental tasks and activities of daily life. AGILECT(R) also showed significant improvement on Clinical Global Improvement (CGI) scale scores rated by the examiner. Quality of life, as measured by the PD -- Quality of Life (PDQUALIF) scale, showed a trend toward improvement in patients treated with AGILECT(R) 0.5 mg/day, but not with AGILECT(R) 1 mg/day.

"Rasagiline decreased 'off' time and increased the amount of 'on' time," said Matt Stern, M.D., professor of neurology at the University of Pennsylvania and co-principal investigator for the PRESTO study. "The efficacy and tolerability of rasagiline, as demonstrated in this trial, combined with its once-daily dosing, suggest it may be a promising new treatment for PD."

Patients on AGILECT(R) experienced side effects similar to those of patients on placebo. Adverse events significantly more common with AGILECT(R) than with placebo were balance difficulty in the 0.5 mg AGILECT(R) group, and weight loss, vomiting, and anorexia in the 1 mg AGILECT(R) group.

Balance difficulty occurred slightly more often in the AGILECT(R) (rasagiline tablets) treated patients, but did not appear to be dose-related. Dyskinesias were reported as an adverse event in 10 percent of patients receiving placebo and 18 percent of patients receiving either dosage of AGILECT(R) but did not lead to early terminations.

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. A new drug application for AGILECT(R) 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(R) 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 North Americans have PD, which usually affects people over the age of 50. The Parkinson Study Group ( http://www.parkinson-study-group.org/ ) is a non-profit, cooperative group of PD experts from medical centers in the United States and Canada who are dedicated to improving treatment for persons affected by PD.

Teva Neuroscience, Inc. and Eisai Inc. will co-promote AGILECT(R) 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, upon expected receipt of Marketing Authorization in Q1 2005.

Teva Pharmaceutical Industries 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 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(R) (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(R) sales, including potential competition from the expected launch of Tysabri(R)/Antegren(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, 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.

* The time when the effects of levodopa have worn off and PD symptoms return or are not adequately controlled.

Teva Neuroscience

CONTACT: Pat Donohue of Eisai Inc., +1-201-287-2978,patricia_donohue@eisai.com ; or Warren Dudley of Fleishman-Hillard Inc.,+1-816-512-2381, dudleyw@fleishman.com

Web site: http://www.parkinson-study-group.org/

Source: PRNewswire-FirstCall

More News in this Category