Xolair Will Wait a Year Before Next Run at Approval

Rejected in July, the asthma drug from Genentech and Novartis will try the FDA again in late 2002.
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said Thursday that their delayed asthma drug Xolair will be resubmitted to the Food and Drug Administration in the fourth quarter of 2002.

The Xolair update puts to rest unanswered questions about the drug's timeline. Xolair went before the FDA for approval in July. The FDA voted not to approve it, asking both Genentech and Novartis to submit additional data. Since then, the companies have been reluctant to offer details on when that data would be ready.

Xolair is especially important for Genentech because it's a key building block for the biotech firm's earnings growth. Peak revenue estimates for the drug range widely, from $500 million to more than $1 billion a year, based on an estimate of 150 million people worldwide who suffer from allergy-related asthma.

If Xolair is resubmitted to the FDA one year from now, the drug could be approved by the end of 2003 or the beginning of 2004. This timeline is at the back end of current Wall Street estimates.

"We have a clear action plan for Xolair and are pleased with the outcome of these discussions with the FDA regarding our proposed submission strategy and timeline," said Joerg Reinhardt, Novartis' head of development.

The additional information required by the FDA is coming from completed and ongoing clinical trials, the companies said. But Xolair is being considered only as an asthma treatment for adults and adolescents older than 12. Previously, the companies had hoped to get the drug approved for children as young as 6.

Shares of Genentech were down 10 cents to $52.15 in Thursday trading. Novartis was up 35 cents to $37.98.