Teva rivals advance on oral MS drug

Merck KGaA and Novartis have completed Phase III trials of their drugs, and are filing for approval.

The ring around Copaxone, Teva Pharmaceutical Industries Ltd.'s (Nasdaq: TEVA; TASE: TEVA) treatment for multiple sclerosis, is tightening. Yesterday, two of Teva's main rivals developing oral treatments for the disease announced that they were applying for approcval of their drugs by the US Food and Drug Administration (FDA). Teva is also trying to develop an oral version of Copaxone.

Germany's Merck KGaA (XETRA: MRK) filed for approval of its multiple sclerosis pill cladribine, two months after filing for EU approval, and Switzerland's Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ) is seeking approval for its drug, FTY720, in both the US and Europe.

Copaxone generates 30-35% of Teva's net profit. The drug is administered by injection, and is considered a safe drug. Teva is undergoing a Phase II clinical trial for oral Copaxone.

Novartis announced successful results of the Phase III clinical trial of FTY720. The company said that the drug delayed development of multiple sclerosis by two years, but that there were dangerous side effects if the drug was taken in high dosages, including high blood pressure, and skin cancer.

Merck KGaA has completed its Phase III clinical trial, which showed in January that cladribine reduced the number of relapses per year in patients with some forms of multiple sclerosis by 58%, compared with a placebo. However, the drug is considered as risky as FTY720. Market sources believe that cladribine will come on the US market in the second quarter of 2010, and European market launch in the fourth quarter of 2010.

Teva's share fell 1.2% to $49.96 at the opening on Nasdaq today. The share fell 0.1% on the TASE today to NIS 189.

Published by Globes [online], Israel business news - www.globes-online.com - on October 1, 2009

© Copyright of Globes Publisher Itonut (1983) Ltd. 2009

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