FDA panel review of Xolair delayed

Novartis AG's US subsidiary Novartis Pharmaceuticals Corp and affiliateGenentech said on March 8 that they have been advised by the Food and Drug Administration that the planned Pulmonary-Allergy Drugs Advisory Committee meeting scheduled for April will not take place. This panel had been set to review the companies' Biologics License Application for Xolair (omalizumab) for the treatment of asthma and allergic rhinitis. At this time, any further further meeting of the committee has not been revealed.

Only a few weeks earlier, the two firms had said that a second-half 2001 launch of Xolair, which is also being developed with Tanox, was on track (Marketletter March 5). They say it is not known if the current FDA discussions will impact the approval timing from the agency, but the companies' plans are still based on an expected approval and launch in the latter part of 2001.

The news sent Genentech's share price down over 5% to $48.10, while that of Novartis in the USA fell 21 cents to $41.75. According to Reuters, analysts expect Xolair to be a blockbuster drug, with an annual sales potential of $2 billion by 2005. For its part, Novartis has previously suggested potential annual turnover of around $590 million in the markets to which it has rights, and a further $1 billion coming from the USA.