Reuters: Regulatory News: Bayer anti-cancer agent gets FDA orphan status

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Bayer anti-cancer agent gets FDA orphan status Jul 18th 2012, 08:11 FRANKFURT, July 18 | Wed Jul 18, 2012 4:11am EDT FRANKFURT, July 18 (Reuters) - Bayer AG said on Wednesday its investigational anti-cancer agent BAY 94-9343, which is currently in Phase I clinical development, received orphan status from U.S. health regulators. The orphan status, which is granted by the U.S. Food and Drug Administration to drugs that treat diseases affecting fewer than 200,000 people, can provide a seven-year marketing exclusivity for a drug from the date of approval.

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