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Teva and Lundbeck Announce That Azilect (Rasagiline) for Parkinson’s Disease is Now Available in the United Kingdom; Additi
Thursday June 30, 2005
June 27, 2005(Business Wire) - Teva Pharmaceutical Industries Ltd. (Teva) (NASDAQ: TEVA) and H. Lundbeck A/S (Lundbeck) (CSE: LUN) announced today that Azilect(R), a once-daily treatment for Parkinsons 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 following the issuance of a Marketing Authorisation by the European Commission 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 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, "Todays launch is an important step in the fruitful collaboration with our commercial partner, Lundbeck, and will be the second product to emerge from Tevas 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 Parkinsons disease", says Ole Chrintz, Lundbecks Executive Vice President in charge of sales and marketing in Europe. He continues: "The launch of Azilect(R) is Lundbecks third launch of a new, innovative drug in Europe within a period of only three years, representing an important contribution to the companys portfolio and long-term strategy of becoming one of the worlds leading companies in the field of psychiatry and neurology."
Azilect(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.
The development of Azilect(R) is part of a long-term alliance for co-development in Parkinsons 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 Parkinsons disease
Parkinsons disease is a chronic, progressive, neurodegenerative disorder. The exact cause of Parkinsons disease is unknown, and is believed to be multifactorial, 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 patients ability to function.
The disease afflicts both sexes equally, and it is estimated that close to 4 million people worldwide suffer from Parkinsons 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 Parkinsons disease. In 2004, global sales of drugs to treat Parkinsons disease totalled USD 2.5 billion. Europe accounted for approximately 40% of this revenue.
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 Tevas sales are in North America and Europe. Tevas innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
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 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 managements current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Tevas 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 Tevas 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, Tevas 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, Tevas 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 Tevas 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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