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News Release - December 22, 2006
Largest Disease Modification Trial for Parkinson's Disease Completes EnrollmentStudy to determine AZILECT(R) effect on slowing disease progression in approximately 1,200 recently diagnosed PD patients
KANSAS CITY, Mo., Dec. 22 (HSMN NewsFeed) -- The largest clinical study to investigate disease modification in early Parkinson's disease (PD) has completed enrollment. The ADAGIO (Attenuation of Disease progression with AZILECT® GIven Once-daily) study is evaluating approximately 1,200 recently diagnosed patients worldwide to determine if treatment with once-daily AZILECT® (rasagiline tablets) can slow the progression of PD.
"We are excited about the approval of AZILECT® in the US as a once-daily treatment for PD as both initial monotherapy and as an adjunctive therapy to levodopa and by the completion of enrollment of this very important trial," said Larry Downey, president and chief executive officer of Teva Neuroscience, Inc.
To date, there are no PD therapies on the market shown to slow, halt, or reverse the progression of this neurodegenerative disease for the 1 million people in the United States suffering from Parkinson's disease. PD continues to challenge researchers. Its symptoms can ultimately rob patients of everyday freedoms, like walking and maintaining control of movement. "The ADAGIO study is designed to separate the symptomatic improvement from any potential disease modifying activity," said Dr. Warren Olanow, professor and chairman of the Department of Neurology at Mount Sinai School of Medicine.
The double-blind, placebo-controlled phase of the study includes two active treatment groups receiving either 1 mg or 2 mg doses of AZILECT® once daily, and one placebo-treated group for 36 weeks. After that period, study participants will either continue on their preassigned active treatment for another 36 weeks or, in the case of placebo patients, be switched to one of the two AZILECT® treatment doses in a blinded fashion. Progression of PD will be assessed using the Total Score of the Unified Parkinson Disease Rating Scale (UPDRS) during the last 36 weeks of the 72-week study.
The study is expected to be completed by mid 2008 and findings are expected to be made public later that year.
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, which included more than 1,500 patients.
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 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 1 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., is promoting AZILECT® in the United States. AZILECT® is a registered trademark of Teva Pharmaceutical Industries Ltd. See additional important information at http://www.AZILECT.com or call 1-877-4 AZILECT for electronic releases. For hardcopy releases, please see enclosed 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 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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