Healthcare Industry News: TYSABRI
News Release - May 17, 2006
AZILECT(R) FDA Approval Brings New Hope to People Living With Parkinson's DiseaseKANSAS CITY, Mo., May 17 (HSMN NewsFeed) -- The U.S. Food and Drug Administration (FDA) has approved AZILECT® (rasagiline tablets), the first once-daily oral treatment for Parkinson's disease (PD). The drug is approved for use as initial monotherapy in early PD and as adjunct therapy to levodopa in moderate-to-advanced disease. It is expected to become available later this year in two dosage strengths.
"Three placebo-controlled clinical trials demonstrated that rasagiline (AZILECT®) showed positive effects on motor impairments and activities of daily living in early PD and in moderate-to-advanced stage patients, and was well tolerated," said Ira Shoulson, M.D., professor of neurology at the University of Rochester School of Medicine, and principal investigator of the Parkinson's Study Group TEMPO and PRESTO studies of AZILECT®.
AZILECT® (rasagiline tablets) was approved based on data from three multicenter, multinational, double-blind, randomized, placebo-controlled, clinical studies, known as "(TVP-1012) in Early Monotherapy for Parkinson's Disease Outpatients" (TEMPO), "Parkinson's Rasagiline: Efficacy and Safety in the Treatment of Off" (PRESTO), and "Lasting effect in Adjunct therapy with Rasagiline Given Once daily" (LARGO). The studies, which included more than 1,500 patients, provided statistically significant evidence of efficacy, while also demonstrating good tolerability. Patients who enrolled in the TEMPO trial had early-stage PD and did not require dopaminergic therapy. The PRESTO and LARGO trials included patients with moderate-to-advanced PD who were receiving optimized doses of levodopa, as well as other PD medications, and were still experiencing motor fluctuations. In LARGO, both AZILECT® and an active comparator were measured against placebo.
The TEMPO trial showed early-stage PD patients who received AZILECT® as monotherapy had better symptom control as measured by total UPDRS* over a 26-week period than those receiving placebo.
The PRESTO trial demonstrated a significant incremental benefit of AZILECT® when added to levodopa treatment and other concomitant PD drugs. In this trial, the amount of "off" time was significantly reduced and motor symptoms were improved compared to placebo. In PD, "off" time is defined as periods of poor overall functioning when the effects of levodopa wear off and symptoms return or are not adequately controlled.
Finally, the LARGO trial demonstrated, when added to levodopa therapy and other concomitant PD medications, AZILECT® reduced "off" time and PD motor symptoms. Additionally, activities of daily living during "off" time were significantly improved by AZILECT® compared to placebo.
"The approval of AZILECT® (rasagiline tablets) by the FDA represents important news for people with Parkinson's disease," said Dr. Warren Olanow, professor and chairman of the Department of Neurology at Mount Sinai School of Medicine. "Parkinson's disease patients can now look forward to an effective new treatment option that improves symptoms and offers the simplicity of once-daily dosing without titration and the flexibility of use as monotherapy in early disease or as adjunct therapy to levodopa as the disease progresses."
"This is a key milestone for our business, but, more importantly, a significant new treatment option for Parkinson's disease patients and their families," said Larry Downey, president and chief executive officer of Teva Neuroscience, Inc. "The approval of AZILECT® is another demonstration of our continuing commitment to helping people cope with neurological diseases."
AZILECT® is indicated for the initial treatment of the signs and symptoms of Parkinson's disease either alone or with levodopa.
Patients should not take AZILECT® if they have moderate to severe liver disease, a tumor of the adrenal gland, or if they are currently taking any of the following medications: meperidine, other MAO inhibitors, tramadol, methadone, propoxyphene, dextromethorphan, St. John's wort, antidepressants, mirtazapine, cyclobenzaprine, non-prescription cold remedies containing decongestants, and local anesthetics containing ingredients that raise blood pressure. Caution should be used when AZILECT® is taken with CYP1A2 inhibitors such as ciprofloxacin. Patients should talk to their doctor about any medications they are currently taking before starting AZILECT®.
In order to prevent a dangerous increase in blood pressure when patients are taking AZILECT®, they should avoid tyramine-rich foods and beverages and dietary supplements such as aged cheeses, air-dried meats, pickled herring, yeast extract, aged red wines, tap/draft beers, sauerkraut, and soy sauce. Symptoms of this reaction include severe headache, blurred vision, difficulty thinking, seizures, chest pain, unexplained nausea or vomiting, or symptoms of a stroke. Patients should seek immediate medical attention if any of these symptoms occur.
Side effects seen with AZILECT® (rasagiline tablets) alone are joint pain and indigestion; and when taken with levodopa are uncontrolled movements (dyskinesias), accidental injury, weight loss, low blood pressure when standing, vomiting, joint pain, nausea, constipation, dry mouth, rash, and sleepiness. Be sure to tell your doctor about these and any other side effects you experience when taking AZILECT®.
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 the disease, which usually affects people over the age of 60.
The Parkinson's Study Group ( http://www.Parkinson-Study-Group.org ), which conducted the TEMPO and PRESTO trials, is a non-profit, cooperative group of Parkinson's disease experts from medical centers in the United States and Canada who are dedicated to improving treatment for persons affected by Parkinson's disease.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA ), headquartered in Israel, is among the top 25 pharmaceutical companies in the world. The company develops, manufactures, and markets generic and branded 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's U.S. innovative product marketing subsidiary, Teva Neuroscience, Inc., will promote AZILECT® in the U.S. Eisai Co., Ltd. has been involved in the development of rasagiline since May 2003, and will continue to collaborate with Teva on the global co-development of rasagiline for potential use in the treatment of Alzheimer's disease. However, Teva understands that Eisai, due to its own business considerations and other priorities, is still considering whether or not to elect to co-promote AZILECT® for Parkinson's disease in the United States.
Teva Neuroscience, Inc., is an indirect wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.
AZILECT® (rasagiline tablets) is a registered trademark of Teva Pharmaceutical Industries Ltd. For more information about AZILECT® call 1-877-4AZILECT.
Please call 1-800-728-8051 for the full prescribing information.
*UPDRS is a commonly used rating scale that measures the ability of the patient to perform mental and motor tasks as well as activities of daily living.
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 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 risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the expected reintroduction of TYSABRI® into the market, 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, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, 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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