The US Food and Drug Administration (FDA) wants more information about Cladribine, an oral treatment for multiple sclerosis developed by Merck KGaA (XETRA: MRK). Although expected, the rejection is good news for Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), as it delays competition to Copaxone.
The European Medicines Agency (EMEA) earlier rejected Cladridine.
Poalim Sahar analyst Yoav Burgen says, "The FDA's response was very expected, but the company itself actually provided in its guidance a scenario in which the FDA approved Cladridine. It seems that the FDA is following the EMEA, and is worried about the drug's problematic safety profile. Since the rejection was expected, the upside for Teva's share is limited, if any."
Teva's share price fell 0.3% on Nasdaq yesterday to $49.93, giving a market cap of $44.8 billion, but rose 0.8% in early trading on the TASE today to NIS 182.80.
Published by Globes [online], Israel business news - www.globes-online.com - on March 2, 2011
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