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Teva Pharmaceutical Industries is hopeful that the second proprietary drug it has developed - Agilect (or Azilect, as it will be marketed in the US) for alleviating Parkinson's disease - will bring the world's patients medical benefits and the company profits as great as that of its first original drug, Copaxone for multiple sclerosis. A $400 million world market is expected to develop for Agilect by the end of this decade.
US sales of the drug - which was approved for sale in Europe and Israel a year ago - will be made possible by Food and Drug Administration (FDA) approval this week. There are about 1.5 million Parkinson's disease sufferers in the US alone. The FDA approved the drug as an initial monotherapy in early Parkinson's disease patients and as adjunct therapy to levodopa in moderate-to-advanced stages of the disease, and it will become available in the US within 10 weeks.
"The addition of Azilect to Teva's proprietary product line will provide another long-term source of sustainable earnings and help diversify its business," Lehman Brothers analyst Richard Silver told clients Thursday. "We expect Azilect to contribute to Teva's bottom line within the next year."
The drug costs about NIS 1,000 a month and is not yet provided by the health funds to Israeli Parkinson's patients, but the pressure for its inclusion will certainly be mounted.
Known generically as rasagiline, the drug was developed and studied for over a quarter of a century by Prof. Moussa Youdim and Prof. John Finberg, two leading researchers at the Technion-Israel Institute of Technology in Haifa, and the rights were purchased by Teva, which develops and markets only generic drugs except for Agilect and Copaxone.
The drug does not cure Parkinson's - a chronic, progressive neurological disorder caused by the death of the brain cells that produce a neurotransmitter called dopamine, whose symptoms include tremors, slowness of movement, stiffness, gait and posture problems, but it is described as a "breakthrough" because it has been shown to slow degeneration of dopamine neurons in the brain and to improve cognitive ability.
Clinical trials on rasagiline have shown statistically significant results in reducing the duration of the "off time" - a state in which Parkinson's patients are unable to function normally. Conventional drugs for Parkinson's, such as levodopa, lose their effect over time, and have to be taken eight times a day. But rasagiline tablets are taken once daily and have shown only minimal side effects in some patients.
In 1967, an Australian company tried to market a primitive variation of the drug molecule for lowering high blood pressure, but the trial failed. The Iranian-born Youdim was the new head of the pharmacology department at the Technion's Rappaport Medical Faculty 25 years ago, when he began his study of the molecule, which he identified as having potential in treating neurodegenerative diseases. He was joined by Finberg, who came on aliya from London in 1970.
"My father died from Parkinson's in 1980," Finberg told The Jerusalem Post on Thursday. "He told me before his death that as a pharmacologist I should find something for that disease. And after coming to the Technion, Moussa and I did. I imagine my father would be proud of me today.
"It could potentially be used for other neurodegenerative diseases, but application is fraught with problems, as there is a gap between findings in basic science in the lab and clinical studies. We hope success of Agilect will stimulate more in-house research by Israeli companies, including Teva, even though biological lab research is a long and hard process.
"The molecule has two different modes of action - it blocks the metabolism of dopamine that is depleted in the brain of the patient and also increases the amount of available dopamine to work on neuronal pathways. There is an immediate reduction in symptoms," said Finberg.
Teva president and CEO Israel Makov added: "The robust results of [clinical] trials have met our expectations with regard to the efficacy of rasagiline. We are extremely pleased with the clinical development of this product which holds promise for patients with both early and advanced stages of Parkinson's disease. These results also encourage us to move forward with investigating rasagiline in other neurological disorders. It fills an important unmet need, offering a new treatment which uniquely combines efficacy, convenient once-daily dosing and good tolerability."