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On 4 Feb 2001, at 12:37, Ann Gibbons wrote: > I'm confused. This exciting article says "It is currently undergoing the > final test in preparation for FDA approval for the treatment of PD.: To > me, this means that it has completed human clinical trials and is about > to be brought to market. But all the research indicates that results > have been obtained in vitro or in rodents. So what's the real status of > Rasagaline? This drug has been talked about for years. Are they only now > applying for human trials? Anybody know? > Hi Ann, Read this one.... Teva Nears Trial Completion for Prospective Parkinson's Treatment NEW YORK, Apr 10 (Reuters Health) - Israel's largest pharmaceutical company, Teva Pharmaceutical Industries, reported positive results from a late-stage clinical trial for use of its rasagiline to treat Parkinson's disease. The phase III study focused on early stage patients not yet treated with levodopa. Results indicated that the "highly significant efficacy" of rasagiline, which is a selective irreversible MAO-B inhibitor, in limiting progression of Parkinson symptoms, Teva said. In the study, 400 patients in the US and Canada were treated over 6 months with two doses of rasagiline or given a placebo. According to Teva, the drug was also well tolerated. The study findings will be presented at a major scientific conference later this year. The Jerusalem-based company has planned two further studies of rasagiline for Europe and North America, which it expects to initiate in the near future. The results will be submitted for regulatory review in the US, Canada, EU and other countries. Both rasagiline and TV-1203, a prodrug of levodopa entering phase III, are part of Teva's global and European marketing and developing alliance with Danish company H. Lundbeck A/S. Under a long-term deal, the companies will share European marketing of these drugs, which target Parkinson's disease. Teva will retain exclusive marketing rights in the rest of the world. With the global market for Parkinson's disease estimated at more than $1.5 billion and expected to double in the next few years, the promising phase III results for one of Teva's Parkinson's drug candidates "support [the company's] accelerated pursuit of the development of both of these therapies," Eli Hurvitz, Teva president and CEO, said. Lundbeck President and CEO Eric Sprunk-Jansen expects the product to be launched worldwide in 3 years, he said. http://cmecenter.medscape.com/reuters/prof/2000/04/04.10/20000410drgd002.html [log in to unmask]