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EU Approval Granted for Stalevo (Levodopa/Carbidopa/Entacapone) New Treatment for Parkinson's Disease LONDON, ENGLAND -- October 23, 2003 -- An EU-wide marketing authorisation has been granted by the European Agency for the Evaluation of Medicinal Products, EMEA, for StalevoŽ, a new treatment developed by Orion Pharma for Parkinson's Disease (PD). Stalevo, which combines levodopa, carbidopa and entacapone in one tablet, represents the first new treatment for Parkinson's disease in three years, and the first new form of levodopa in more than a decade. Stalevo is indicated for patients with idiopathic PD who experience signs and symptoms of end-of-dose "wearing off". A US marketing authorisation for the product was received in June, and the product has already been launched there. Orion will introduce the product to the first European markets during the current quarter 2003. Stalevo is anticipated to become the leading product in Orion's proprietary portfolio. Levodopa is the most effective and widely used agent available for Parkinson's disease. Entacapone and carbidopa are enzyme-blocking compounds that enhance the therapeutic benefits of levodopa. At the start of levodopa treatment, the effect of levodopa lasts for many hours. However, even within just two years approximately 40 percent of patients begin to notice that their levodopa lasts for shorter periods of time, a phenomenon known as "wearing off". Eventually, the effect of a levodopa dose may decrease to only one to two hours. Most Parkinson's disease patients will experience "wearing off" and in many patients, "wearing off" becomes increasingly disabling during the course of disease. "With Stalevo we can enhance the benefits of levodopa and more effectively treat the problems such as "wearing off" that complicate the long-term use of levodopa and limit its utility. Stalevo thus represents an important advance in our ability to treat Parkinson's disease patients", said professor David Brooks, one of the leading Stalevo investigators, at the Medical Research Council Clinical Sciences Centre and Imperial College London, UK. The effectiveness of levodopa, carbidopa and entacapone in the treatment of Parkinson's has been established in multicenter, randomised, double blind placebo-controlled trials in patients experiencing "wearing off". The components of Stalevo were shown to increase the period where patients experience no symptoms and improve motor function and daily activities such as patients' ability to walk, dress, and maintain hygiene. In addition, in a separate study, most patients regarded Stalevo as easy to dose, use, handle and swallow. In all studies Stalevo was well tolerated, the most commonly reported adverse events being uncontrolled movements (dyskinesias) and nausea. The side effects are generally mild to moderate in nature and if they occur, they can usually be managed with dose modifications. Side effects seldom lead to treatment discontinuation. Stalevo is a significant new product introduction from the R&D pipeline of Orion Pharma. Orion is the originator and manufacturer of entacapone, the leading COMT-inhibitor used as an important adjunct to levodopa in the treatment of PD. Entacapone was launched in 1998-1999 world-wide as Comtess and Comtan, and it soon became Orion's best-selling brand. Stalevo will be available in Europe from Orion Pharma and Novartis. Orion's territories include Germany, UK and Ireland, all the Nordic countries, and the Baltic states. The other markets are licensed to Novartis, which is also the marketer of entacapone under the name Comtan. Orion will receive a milestone payment of USD 5 million from Novartis triggered by the EU marketing authorisation. SOURCE: Ogilvy Public Relations Worldwide http://tinyurl.com/s7qd * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn