Prof. Moussa Youdim sits in his lab in the pharmacology department at the Haifa Technion School of Medicine in Israel. (Photo: Technion)A drug for Parkinson’s disease developed and studied over a quarter of a century at the Technion in Haifa has shown to be significantly effective in treating patients in the disease’s advanced stage.
The Teva company announced the substantial research showing that its new drug Rasagiline, has the ability to slow the progress of the neurological disorder that affects over one million Americans. The successful two phase-III clinical trials means that the new drug may be on the market in the U.S. and Europe as early as next year.
The excitement at the announcement last week was tangible at the Haifa Technion. Rasagiline was developed by Teva based on the original research of Prof. Moussa Youdim and Prof. Johan Feinberg of the pharmacology department at the Haifa Technion School of Medicine in Israel.
“I’m thrilled. This is my life’s work and I have always believed in this drug,” Youdim said after the publication of the results
There are 20 new cases of Parkinson’s Disease per 100,000 population per year. Given the aging of the population in the Western world, the drug’s market is huge.
Parkinson’s is caused by the death of the brain cells that produce dopamine, the chemical messenger that helps control muscle movement. A chronic, progressive and ultimately fatal disease, it is characterized by uncontrollable shaking and an inability of the brain to command muscles to move in a prescribed way.
In the two promising Phase III clinical trials of Rasagiline released last week, the drug was deemed successful. The two studies compared once-daily dosages of Rasagiline to a placebo and demonstrated significant reductions in the duration of the “off” time. It is estimated that over one-third of patients diagnosed with advanced Parkinson’s disease using current medications experience many hours of “off” time daily, in which they are unable to function normally, and develop complications as a result of the standard medication. When these patients took the Teva product in conjunction with the most commonly prescribed medication, Levodopa, the complications were reduced, together with the “off” time.
Conventional drugs for Parkinson’s, which lose their effect over time, have to be taken eight times a day. Youdim said that the side effects of rasagiline were minimal, and that the trials showed they were not greater than those in patients who took only the harmless placebo.
The clinical trials took place in Israel, North America, Europe, and Argentina.
The results of these two trials follow the successful results of an earlier phase III trial which demonstrated the efficacy of Rasagiline alone in early-stage Parkinson’s disease.
With these successful results, Rasagiline is now expected to be submitted for regulatory approval in North America and Europe during the second half of 2003. The trial’s success substantially improves the chances for final FDA approval of the drug and its launch by the first quarter of 2004
Youdim, a scientist born in Iran who studied and conducted research in England before moving to Israel, said that the drug will probably be tested on Alzheimer’s disease and multiple sclerosis as well. “I always believed in this drug. It is my life work.”
In 1967, an Australian company tried to market a primitive variation of the drug molecule for lowering high blood pressure, but the trial failed. Back then, Youdim identified the potential of the molecule in treating neurodegenerative diseases.
Youdim brought the drug to Israel in 1977, when he was appointed head of the new Pharmacology department at the Technion’s Faculty of Medicine. Through animal experiments it became clear that the drug is efficacious in preventing neuron death.
Rasagiline is a molecule that was developed by Youdim and his group at the Eve Topf Neurodegenerative Diseases Research and Teaching Center in the Department of Pharmacology at the Technion’s Faculty of Medicine. Teva Pharmaceuticals developed the drug based on this research. In experiments performed initially in animals, in was shown that the drug prevents degeneration of the neurotransmitter dopamine in the brain and improves cognitive function.
Youdim explained that the human nervous system is comprised of neurons that join together to create nerves. Neuron loss is part of the normal process of aging, but in Parkinson’s disease, as in Alzheimer’s disease, this process is speeded up. Treating animals with Rasagiline succeeded in preventing this process to a significant degree, and now it has been shown that its beneficial effects extend to Parkinson’s patients.
Israel Makov, President and CEO of Teva said: “The robust results of these 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.”
The development of Rasagiline comes on the heels of Teva’s tremendous success with the multiple sclerosis treatment Copaxone.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies in the world. Close to 90% of Teva’s sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva’s innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
The development of Rasagiline is part of a long-term strategic alliance for global co-development and European marketing between Teva and Lundbeck. Lundbeck 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.
Under the terms of the agreement, Lundbeck will market Rasagiline in Europe and in a number of overseas markets, in a joint effort with Teva, while Teva retains exclusive marketing rights in the rest of the world, including North America.