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Novartis: Triple-Combination Should Assure Leadership Novartis' Parkinson's disease drug Stalevo has been launched in the US. September 18, 2003 6:45 PM GMT (Datamonitor) - Stalevo will provide Novartis with an opportunity to gain leadership in the $2.3 billion Parkinson's disease market. In 2002, Novartis' two products in the sector, Comtan and Parlodel (bromocriptine), attained global sales of around $102 million and $67 million respectively. However, Novartis' new novel triple-drug product could draw even stronger returns. The FDA approved Novartis' new treatment for Parkinson's disease (PD) in June 2003. Now launched, Stalevo (carbidopa, levodopa and entacapone) is the first new treatment for PD in three years, and the first new form of levodopa in more than a decade. Launch in the EU is expected in early 2004, where it will be co-promoted with Novartis' collaborative partner and originator of the drug, Orion. Stalevo is a novel drug, which combines the gold standard PD therapy levodopa and carbidopa with Novartis' existing brand Comtan (entacapone) into one convenient pill. Carbidopa is often used with levodopa to help prevent the peripheral conversion of levodopa to dopamine and the resultant nausea and vomiting that can occur. This adverse effect is due to stimulation of dopamine receptors in the postrema region of the brain not protected by the blood brain barrier. However, even with this combination, only 10% of dopamine reaches the brain intact, due to it being converted by peripheral COMT to an inert metabolite. COMT-inhibitors, such as Comtan, prevent this conversion and can prolong levodopa's availability to the brain. This action allows patients to stay active for longer between doses and reduces some of the burdensome symptoms of PD. However, the problem with taking Comtan is that it greatly increases the number of pills a patient has to take every day: one Comtan pill has to be taken with every levodopa/carbidopa pill up to three times daily. Novartis and Orion believe their one tablet formulation, the first triple combination product for PD, will simplify the treatment of the disease, which in turn will increase compliance. For Orion, the partnership with Novartis to develop and market the product will help further establish the biotech company's position in the lucrative US pharmaceutical market. In addition to Stalevo, the predicted launch of Novartis' pipeline PD drug (the neuroprotectant TCH-346) by 2006 will further leverage the company into the market, making it one of the leading players over the next eight years. SOURCE: Datamonitor / UK Comment Wire, UK http://www.commentwire.com/commwire_story.asp?commentwire_ID=4823 Reference: NEWS: FDA Approves Stalevo (TM) for Treatment of Parkinson's http://neuro-mancer.mgh.harvard.edu/ubb/Forum71/HTML/008554.html FDA APPROVES First New Drug for PD in over 3 years http://neuro-mancer.mgh.harvard.edu/ubb/Forum71/HTML/008656.html New Parkinson’s Disease treatment Stalevo available in US pharmacies http://www.novartis.com/ STALEVO is a new therapy for people with Parkinson’s disease (PD). In addition to carbidopa and levodopa (active ingredients in Sinemet®*), STALEVO contains entacapone (active ingredient in COMTAN®), a substance that enhances the benefits of levopoda. http://www.stalevo.com:80/index.jsp?checked=y New York/Basel, 17 October 2002 – At its Pharmaceuticals 'R&D day' in New York today, Novartis is unveiling details of its pipeline, a strong R&D engine to sustain the launch of innovative medicines. SNIP TCH346 (Parkinson's disease) is currently undergoing Phase II clinical trials for Parkinson's disease and amyotrophic lateral sclerosis. Preclinical trials suggest that TCH346 has a unique pharmacological action that may offer neuroprotection, bringing much benefit to the rapidly growing population of Parkinson's disease sufferers. http://tinyurl.com/nx83 Current Clinical Trials at IND SNIP Parkinson’s Disease Trials For those newly diagnosed with Parkinson's Disease (PD): SNIP TCH346: An agent that shows promise in slowing down the disease process of Parkinson’s disease and the development of symptoms. http://www.indd.org/research/clinical.html * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn