Clinical trial data confirms efficacy of Novartis' Xolair in asthma

The prospects for Novartis' anti-immunoglobulin E antibody Xolair(omalizumab) have been lifted by the presentation of positive clinical trial data at the American Academy of Allergy, Asthma and Immunology meeting, along with problems associated with a potential competitor, Immunex' Nuvance (soluble interleukin-4 receptor; see page 18). Novartis is developing Xolair alongside Genentech and Tanox.

Analysts at Julius Baer note that "the efficacy of Xolair was soundly demonstrated. From our point of view, the most important result in terms of sales potential was the data on reductions in hospitalization. In a year-long study, no children taking Xolair were hospitalized for emergency asthma attacks, compared to 4.6% of those in the placebo arm." They go on to note that the benefit of hospitalization was less apparent in adult patients (less than 1% for Xolair versus 2.5% for the placebo group), which may be significant because"since the drug is expected to be expensive, we believe that sales will depend on a demonstrated cost benefit over conventional therapy."

Another potentially positive development for Novartis, the analysts note, is that the US Food and Drug Administration has scheduled another pulmonary/allergy drug advisory committee meeting for May 11, which could mean an earlier-than-expected appraisal after the drug's original panel meeting, scheduled for April 26, was cancelled (Marketletter March 19). Julius Baer remains confident of a launch for Xolair in the fourth quarter of this year.