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Novartis drug hits regulatory hurdle

Novartis in canton Basel Keystone

The life sciences giant, Novartis, said on Wednesday that its new asthma drug, Xolair, has not satisfied the American regulatory authorities, which have requested further information.

A statement from the company said it would provide fresh data to the US Food and Drug Administration with conservative estimates for the new submission ranging from 2002 to early 2003. The company said the drug’s approval in the European Union was also subject to delay.

Analysts say there are concerns about the drug’s side effects and warned that the setback could have a negative impact on earnings. It is now unlikely that Xolair could reach the market before 2004.

Shares in Novartis fell four and a half per cent with the announcement to a 13-month low of SFr58.80 ($33), ending the day just off lows at SFr58.95

Novartis is developing Xolair in an alliance with the American company, Genentech.

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