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News Release - July 31, 2006
Teva Neuroscience Announces AZILECT(R) Is Now Available in Pharmacies - the First, Once-Daily Treatment for Parkinson's DiseaseNew treatment option and its accompanying 'PD Exercise Kit' is a welcome addition to the PD community
KANSAS CITY, Mo., July 31 (HSMN NewsFeed) -- Teva Neuroscience announced today the launch of AZILECT® (rasagiline tablets), the first, once-daily treatment for Parkinson's disease (PD) now available in pharmacies by prescription only. This is important news for the majority (83%) of respondents in a survey of those living with PD who report taking their PD medications up to five times/day.
AZILECT® is indicated for use as initial monotherapy in early PD and as adjunct therapy to levodopa in moderate-to-advanced disease. Based on survey results of 276 persons living with PD, Teva has created the PD Exercise Kit in conjunction with the launch of AZILECT®. Teva is committed to providing resources that can help people effectively manage PD. The Kit includes information on the availability of once-daily AZILECT®, an online fitness tracker, and PD-specific exercise options created by actress and health and fitness guru Marilu Henner. The company is also offering the AZILECT® My Exercise Contest with the opportunity to win a trip to the Parkinson's Unity Walk. For more information, visit http://www.azilect.com .
"AZILECT® provides physicians and people living with PD another treatment option to help control the symptoms of Parkinson's disease. AZILECT® (rasagiline tablets) is well tolerated and offers convenient dosing, making it a good choice for people living with PD in both early and moderate-to-advanced stages of the disease," said Larry Downey, president and chief executive officer of Teva Neuroscience, Inc. "Consumers and caregivers are becoming more proactive in disease management, so we believe it is critical to provide them with tools and resources in addition to AZILECT®."
AZILECT® was approved by the Food & Drug Administration May 17, 2006, based on data from three multicenter, multinational, double-blind, randomized, placebo-controlled, clinical studies. The studies, which included more than 1,500 patients, provided statistically significant evidence of efficacy, while also demonstrating good tolerability as both initial monotherapy in early disease and adjunct therapy in moderate-to-advanced disease.
A survey of 276 people living with PD confirmed that they have many treatment options for PD.
Teva Neuroscience believes that AZILECT® will help patients manage symptoms of PD. In addition, the survey respondents reported that they are not well connected with on-line PD resources or with others living with the disease. Some are also interested in sharing their first-hand accounts of what it is like to live with PD. Some people living with PD say there is a benefit to exercise when paired with the right drug treatment, on symptom control.
"The launch of AZILECT® is exciting for physicians, their patients, and caregivers living with PD," said Dr. Warren Olanow, professor and chairman of the Department of Neurology at Mount Sinai School of Medicine. "AZILECT®'s availability and the PD Exercise Kit are new tools to help people living with PD better manage their disease."
"The convenience of once-daily dosing and the flexibility of use as monotherapy in early disease or as adjunct therapy to levodopa makes AZILECT® a good treatment option for those living with PD."
AZILECT® (rasagiline tablets) is indicated for the treatment of the signs and symptoms of Parkinson's disease (PD) both as initial therapy alone and to be added to levodopa later in the disease. The effectiveness of AZILECT was shown in patients with early PD who were receiving AZILECT as initial therapy alone and who were not receiving any other PD therapy. The effectiveness of AZILECT as adjunct therapy was shown in patients with PD who were treated with levodopa.
-- Patients should not take AZILECT if they are currently taking meperidine as it could possibly result in a serious reaction such as coma or death.
-- Patients should not take AZILECT with tramadol, methadone, propoxyphene, dextromethorphan, St. John's wort, mirtazapine, or cyclobenzaprine.
-- Patients should not take AZILECT with other monoamine oxidase inhibitors (MAOIs), amphetamines, cold remedies containing decongestants and weight-reducing preparations containing pseudoephedrine, phenylephrine, phenylpropanolamine, or ephedrine in order to avoid a possibly dangerous increase in blood pressure. Symptoms of this reaction include severe headache, blurred vision, difficulty thinking, seizures, chest pain, unexplained nausea or vomiting, or signs or symptoms of a stroke. Patients or caregivers should seek immediate medical attention if these symptoms or other unusual symptoms occur.
-- In order to prevent a possibly dangerous increase in blood pressure, patients taking AZILECT should avoid foods and beverages high in tyramine content such as aged cheeses, air-dried meats, pickled herring, yeast extract, aged red wines, tap/draft beers, sauerkraut, and soy sauce.
-- Patients taking AZILECT should not have elective surgery requiring general anesthesia, and should not receive cocaine or other local anesthesia that contains ingredients that could raise blood pressure.
-- Patients should inform their physician if they are taking, or planning to take, any prescription or over-the counter drugs, especially antidepressants and ciprofloxacin.
-- Patients with moderate to severe liver disease or a tumor of the adrenal gland should not take AZILECT.
-- All PD patients are advised to monitor for melanoma (skin cancer) frequently and see a dermatologist on a regular basis.
Side effects seen with AZILECT (rasagiline tablets) alone are headache, joint pain and indigestion; and when taken with levodopa are uncontrolled movements (dyskinesias), accidental injury, nausea, weight loss, constipation, low blood pressure when standing, joint pain, vomiting, dry mouth, rash, and sleepiness. Patients should tell their doctor about these and any other side effects they 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.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA ), headquartered in Israel, is among the top 20 pharmaceutical companies in the world. The company develops, manufactures, and markets innovative and generic human pharmaceuticals and active pharmaceutical ingredients. Over 80% 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. AZILECT® is a registered trademark of Teva Pharmaceutical Industries Ltd. For more information about AZILECT® call 1-877-4AZILECT.
Please visit http://www.AZILECT.com for the full prescribing information.
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.
Source: Teva Pharmaceutical
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