Azilect® (rasagiline) recommended
for approval in the EU
H. Lundbeck A/S and Teva Pharmaceutical Industries Ltd. announced today that the Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of Azilect® (rasagiline) 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 disease.
Following this recommendation, final marketing authorization covering European Union (EU) countries, is expected to be granted by the European Commission in the first quarter of 2005.
Upon approval, Lundbeck and Teva will launch rasagiline in the EU under the brand name Azilect®.
"We are extremely pleased to have received the Committee's positive recommendation, which is a significant step towards Azilect® becoming an important new treatment option in the EU for patients suffering from Parkinson's disease," said Israel Makov, President and CEO of Teva. He added: "This achievement reflects the strength of the collaboration between Teva and Lundbeck and we look forward to continued success in the launch and co-promotion of Azilect® in the first half of next year."
The CHMP, comprised of regulators from the EU countries, based its positive opinion on the review of a comprehensive data package supporting the efficacy and safety of rasagiline, collected from studies that enrolled over 1,600 patients in all stages of the disease. In early PD, Azilect® monotherapy showed significant improvement in motor symptoms and quality of life. In advanced PD, Azilect® significantly reduces daily "off" time thereby improving the disabling motor fluctuations associated with advanced stages of the disease.
"Azilect® provides a new opportunity for people suffering from PD by offering a treatment that significantly improves PD symptoms throughout the course of the disease," said Claus Bræstrup, President & CEO of Lundbeck. "Azilect® is of strategic importance to Lundbeck as it constitutes the Company's first launch of a treatment for Parkinson's disease thereby expanding its presence within the neurology area".
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 2004.
Steen Juul Jensen, Vice President, tel +45 36 43 30 06
Jacob Tolstrup, Investor Relations Manager, tel +45 36 43 30 79.
Helle Hedegaard Juhl, Media Relations Officer, tel +45 36 43 41 68.
Dan Suesskind, Chief Financial Officer, Teva Pharmaceutical Industries Ltd., tel +972-2-589-2840
Bill Fletcher, President and CEO, Teva North America, tel +1 215 591-8800
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.
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