COPENHAGEN, Feb. 22, 2005 - H. Lundbeck A/S and Teva Pharmaceutical Industries Ltd. (Teva) announced today that the European Commission has given the final EU marketing authorisation for Azilect® for the treatment of Parkinson's disease both as initial monotherapy in patients with early Parkinson's disease (PD) and as adjunct treatment in moderate-to-advanced PD. The companies intend to market the product in various countries across Europe during the second quarter 2005.
Azilect (rasagiline) Approved in the EU
About Azilect®: Azilect® 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 rasagiline is part of a long-term alliance for co-development in Parkinson's disease and European marketing between Lundbeck and Teva.
Azilect® is a joint development of Teva and the Technion - Israel Institute of Technology. About Parkinson's disease Parkinson's disease is a chronic, progressive neurodegenerative condition. The exact cause of PD is not known and is believed to be multifactorial involving genes, environmental factors and aging.
Symptoms include tremor, slowness of movement, stiffness, gait and posture problems. As the disease progresses, symptoms worsen, the patient is likely to experience motor complications. Eventually, the disease impairs the patient's ability to function.
PD affects men and women equally, and an estimated four million people worldwide suffer from the disease. The disease typically occurs at a late age, affecting approx. 1% of the population over the age of 65. It is estimated that well over one million people in the EU suffer from PD. In 2003, the worldwide sales for PD drugs reached USD 2.2 billion with approximately 40% of this in Europe.
The content of this release will have no influence on the Lundbeck Group's expectations for the financial result for 2005, which will be presented on March 9, 2005.
Investor contact - Jacob Tolstrup, Investor Relations Manager, tel +45 36 43 30 79. Media contact - Helle Hedegaard Juhl, Media Relations Officer, tel +45 36 43 41 68. Teva contact - Dan Suesskind, Chief Financial Officer, Teva Pharmaceutical Industries Ltd., tel +972-2-589-2840 - George Barrett, President and CEO, Teva North America, tel +1 215 591-3030 - Dorit Meltzer Director, Investor Relations, Teva Pharmaceutical Industries Ltd., tel +972-3-926-7554
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 25 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 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.
H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2003, the company's revenue was DKK 9.9 billion. The number of employees is approx. 5,000.
Rasagiline : structure
Azilect granted USA license May 2006
Approval of rasagiline (Azilect) for PD in Israel
Rasagiline (Agilect, Azilect) in the European Union
Once-Daily rasagiline (Azilect) for both early and more advanced Parkinson's Disease