Roche Share Price Dips On Xenical delay

Shares in Roche fell by 5.6% on Thursday August 28 after the Swiss firmannounced that it was temporarily withdrawing its application to market its new obesity drug Xenical (orlistat) in the USA. Roche's most-commonly traded nonvoting shares fell 745 Swiss francs ($497.36) to 12,600 on the Zurich stock exchange.

At issue appears to be the fact that the US Food and Drug Administration has asked Roche to gather further information on a number of breast cancer cases observed in clinical trials, and the company has been unable to do so in the timeframe allowed under the agency's fast-track procedure.

On May 14, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously recommended the approval of orlistat. Under the terms of the US Prescription Drug User Fee Act, the time for FDA review of the priority application has now expired, before Roche was able to furnish the agency with the analyses it required for approval.