Over the Sukkot holiday, Novartis, as expected, received US Food and Drug Administration (FDA) approval to sell its orally administered multiple sclerosis treatment Gilenia in the US. Merck and Teva have also developed oral MS treatments, but Novartis has made the most progress.
Merck suffered a setback at the end of last week when the European health authorities refused to approve its drug Cladribine for sale, on the grounds that the drug's benefits did not outweigh its risks. This decision, against which the company is expected to appeal, may also influence a future decision by the FDA on the drug.
Teva is has developed a drug called Laquinimod for oral treatment of multiple sclerosis. Laquinimod is set to reach the market third, after Gilenia and Cladribine, in 2012.
The approval for Gilenia changes the picture as far as competition in treatments for multiple sclerosis is concerned. At present, drugs for treating the disease are administered by injection. One of the foremost such drugs is Teva's Copaxone. Patients will not be transferred to oral treatments instantly, but in the long run such treatments are likely to erode sales of Copaxone.
Clal Finance analysts Yuval Ben-Zeev and Jonathan Kreizman do not expect substantial impact on Teva's revenue from Copaxone before 2012. They estimate that Gilenia will hit injected drugs Avonex and Tysabri before it affects sales of Copaxone, but that the threat from orally administered drugs is clearly close and real.
IBI analyst Natali Gotlieb estimates that oral multiple sclerosis treatments will lead to an increase in the number of patients treated, and will not greatly affect sales of existing drugs such as Copaxone. In the long run, she sees the supply of such products rising, which will lead to lower sales of existing drugs.
Published by Globes [online], Israel business news - www.globes-online.com - on September 26, 2010
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