 |
 |
Company Press Release: DuPont Pharmaceuticals and Roche to Co-Promote Treatment for Parkinson's Disease WILMINGTON, Del. and NUTLEY, N.J., Aug. 4 /PRNewswire/ -- DuPont Pharmaceuticals Company and Hoffmann-La Roche announced today an agreement to co-promote their products for the treatment of Parkinson's disease. DuPont Pharmaceuticals currently markets Sinemet(R) CR (carbidopa-levodopa) Sustained Release Tablets, the leading carbidopa-levodopa therapy prescribed by U.S. neurologists. Roche manufactures and markets Tasmar(R) (tolcapone), the first of a new class of drugs called catechol-O-methyltransferase or COMT inhibitors, which are taken as adjunctive therapy to carbidopa-levodopa, including Sinemet CR. When taken together, the combined therapy significantly improves some patients' ability to function. Fluctuating Parkinson's patients taking the combined drugs gained a daily average of 1.7-2.9 hours of ``on-time'' (periods of relatively good functioning). According to the three-year agreement, sales forces from DuPont Pharmaceuticals and Roche will co-promote the two products to neurologists and other physicians treating patients with Parkinson's disease in the United States. ``Several clinical studies suggest that, in some patients, treatment regimens that produce steady plasma levels of levodopa may attenuate motor fluctuations. Sinemet CR provides smoother plasma levels when compared to immediate-release Sinemet. Although the precise mechanism of action is unknown, it is believed that the addition of Tasmar substantially enhances and sustains the plasma levels more than when levodopa is given alone,'' says Dr. Abraham Lieberman, medical director at the Barrow Neurological Institute in Phoenix. ``It's a logical partnership,'' he added. ``These sustained plasma levels of levodopa result in more constant stimulation in the brain, leading to greater positive effects on the signs and symptoms of Parkinson's disease. The combined therapy is really a very exciting treatment advancement.'' ``Levodopa has long been considered the gold standard of therapy for Parkinson's disease,'' said Nicholas L. Teti, president, DuPont Pharmaceuticals. ``This partnership with Roche emphasizes DuPont Pharmaceuticals' continuing commitment to our customers through the provision of upgraded solutions to their treatment needs.'' ``Tasmar has been exceptionally well-received by physicians and patients alike since it was launched in February,'' said Stephen G. Sudovar, president, Roche Laboratories, Inc. ``Doctors are telling us that it fills a void among treatment options.'' As with all medications, there are some side effects associated with Sinemet CR and with Tasmar. Overall, the most common side effects seen with Sinemet CR are dyskinesias, nausea, hallucinations, confusion, and dizziness. Sinemet CR may cause more dyskinesias than Sinemet (carbidopa-levodopa) Tablets (16.5% vs. 12.2%). Sinemet CR should not be chewed or crushed, and Sinemet CR 25-100 should not be halved. Sometimes the effect of the first morning dose of Sinemet CR may be delayed up to 1 hour compared to Sinemet. In clinical trials, the most common side effects seen in patients adding Tasmar to carbidopa/levodopa were dyskinesias (involuntary movements), nausea, sleep disorders, dystonia, anorexia, diarrhea, somnolence, excessive dreaming, muscle cramps, orthostatic complaints/syncope, dizziness, headache, hallucination and confusion. Most of these side effects are dopaminergic and can usually be managed by decreasing the dose of levodopa; however, some may persist despite levodopa dose adjustment. Diarrhea was the side effect that most commonly lead to discontinuation. Liver enzymes should be monitored when initiating Tasmar and as recommended for the first six months of therapy. NOTE: Full prescribing information for both products available upon request or visit our websites at www.dupontpharma.com and www.tasmar.com. Sinemet is a registered trademark of Merck and Co, Inc. SOURCE: DuPont Pharmaceuticals Company; Hoffmann-La Roche -- Judith Richards, London, Ontario, Canada [log in to unmask]