Teva and Lundbeck Announce That Azilect (Rasagiline) for Parkinson's Disease is Now Available in the United Kingdom; Additional Launches in Europe to Follow.JERUSALEM & COPENHAGEN, Denmark -- Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd. (Teva) (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : TEVA) and H. Lundbeck A/S (Lundbeck) (CSE (Certified Systems Engineer) See Microsoft certification. : LUN) announced today that Azilect(R), a once-daily treatment for Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. (PD) both as monotherapy in patients with early PD and as an adjunct treatment in moderate to advanced disease, is now available in the United Kingdom. This represents the first launch of Azilect(R) in a member nation of the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community following the issuance of a Marketing Authorisation by the European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community earlier this year. The Marketing Authorisation is valid throughout the European Union and additional launches are planned for the remainder of this year and for 2006. The next launch is expected to take place in Germany within a few weeks time. Israel Makov, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Teva commented: "We are very excited to announce the first European launch of Azilect(R). It is extremely fulfilling to successfully develop and launch a new therapy that addresses important unmet needs for PD patients and improve their quality of life". Mr. Makov added, "Today's launch is an important step in the fruitful collaboration with our commercial partner, Lundbeck, and will be the second product to emerge from Teva's close relationship with the world renowned academic research institutes in Israel." "Azilect(R) is an effective, simple and well tolerated drug for the treatment of both early and late-stage Parkinson's disease", says Ole Chrintz, Lundbeck's Executive Vice President in charge of sales and marketing in Europe. He continues: "The launch of Azilect(R) is Lundbeck's third launch of a new, innovative drug in Europe within a period of only three years, representing an important contribution to the company's portfolio and long-term strategy of becoming one of the world's leading companies in the field of psychiatry and neurology." About Azilect(R) Azilect(R) is a novel, potent, second-generation selective irreversible monoamine oxidase Monoamine oxidase Either of two enzymes found in the outer membrane of mitochondria that degrade biogenic amines and are thus responsible for the destruction of transmitter substances at neuronal synapses. type B (MAO-B) inhibitor that blocks the breakdown of dopamine dopamine (dōp`əmēn), one of the intermediate substances in the biosynthesis of epinephrine and norepinephrine. See catecholamine. dopamine One of the catecholamines, widely distributed in the central nervous system. , a substance in the brain needed to facilitate movement. The development of Azilect(R) is part of a long-term alliance for co-development in Parkinson's disease and European marketing between Lundbeck and Teva. In the three major European markets, the United Kingdom, Germany and France Teva and Lundbeck will co-promote Azilect(R). Azilect was developed by Teva based on research originating from the Technion, Israel Institute of Technology". About Parkinson's disease Parkinson's disease is a chronic, progressive, neurodegenerative disorder neurodegenerative disorder Neurology A chronic progressive neuropathy characterized by selective and generally symmetrical loss of neurons in motor, sensory, or cognitive systems Types by area Cerebral cortex–Alzheimer's disease, Pick's disease, Lewy body . The exact cause of Parkinson's disease is unknown, and is believed to be multifactorial multifactorial /mul·ti·fac·to·ri·al/ (mul?te-fak-tor´e-al) 1. of or pertaining to, or arising through the action of many factors. 2. , involving genes, environmental factors and aging. Symptoms include tremors, slowness of movement, stiffness, gait and posture problems. As the disease progresses, symptoms worsen, and the patient will most likely experience motor complications. Ultimately, the disease impairs the patient's ability to function. The disease afflicts both sexes equally, and it is estimated that close to 4 million people worldwide suffer from Parkinson's disease. The disease typically appears at a late age, affecting about 1% of the population over the age of 65. It is estimated that more than one million people in the EU suffer from Parkinson's disease. In 2004, global sales of drugs to treat Parkinson's disease totalled USD USD In currencies, this is the abbreviation for the U.S. Dollar. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 2.5 billion. Europe accounted for approximately 40% of this revenue. About Teva Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 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% of Teva's sales are in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system. About Lundbeck H. Lundbeck A/S is an international pharmaceutical company engaged in research and development, production, marketing and sales of drugs for the treatment of psychiatric and neurological disorders. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement under the U. S. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 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, 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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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