Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has announced that it has received approval from the US Food and Drug Administration (FDA) for once-daily Azilect (rasagiline tablets) as a treatment for Parkinson's disease.
The drug is approved both as initial monotherapy in early Parkinson's disease patients and as adjunct therapy to levodopa in moderate-to-advanced stages of the disease.
Azilect will become available in the US within 8 to 10 weeks. It was approved in Europe and in Israel in 2005.
The drug was developed by Teva on the basis of research originating from the Technion Israel Institute of Technology.
Teva president and CEO Israel Makov said, "We are extremely pleased to receive FDA approval for Azilect, the only once-daily product and one of the few treatment options in the US indicated for all stages of Parkinson's disease including as monotherapy in the early stages and as adjunct to levodopa in the more advanced stages.
"Azilect fills an important unmet need, offering a new treatment which uniquely combines efficacy, convenient once-daily dosing and good tolerability. The upcoming launch of Azilect represents a key milestone in our commitment to develop and bring to market novel therapies for neurological diseases.
"We have recently embarked on a large clinical study (ADAGIO), to investigate the impact of Azilect on slowing the progression of Parkinson's disease. If it is demonstrated that Azilect does indeed slow the progression of PD, this will undoubtedly represent a major breakthrough for Parkinson's disease patients."
Teva's US subsidiary, Teva Neuroscience, Inc., will promote Azilect in the US. Teva said that Eisai, which has been involved in the development of rasagiline since May 2003, will continue to collaborate with Teva on the global co-development of rasagiline for potential use in the treatment of Alzheimer's disease, but that Eisai was still considering whether or not to elect to co-promote Azilect for Parkinson's disease in US.
Azilect is Teva's second ethical drug. The first was Copaxone, which has become a leading treatment for multiple sclerosis.
In early trading in New York, Teva shares are down slightly at $38.11, giving the company a market cap of $23.66 billion. The share price fell steeply last week, after the company published disappointing first quarter results.
Published by Globes [online], Israel business news - www.globes.co.il - on May 17, 2006
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