Novartis and B-MS withdraw Zelmac application in Europe

Novartis and partner Bristol-Myers Squibb have suffered a setback withthe withdrawal from the European Medicines Evaluation Agency of their marketing application for Zelmac (tegaserod), a 5-HT4 receptor partial agonist for irritable bowel syndrome which has been tipped as a potential blockbuster. Novartis' share price closed down 4.6% at 68.25 Swiss francs ($38.37) on the date of the news (May 31), while B-MS was down marginally to $54.24.

The decision has come about as a result of a difference of opinion with the EMEA's Committee for Proprietary Medicinal Products regarding the efficacy of the drug, as demonstrated in Novartis and B-MS' clinical trials for tegaserod, as well as disagreement over the methodological conduct of some preclinical studies. The companies stressed that they remain committed to marketing the drug in Europe and are considering options for resubmission.

Tegaserod has also run into regulatory hurdles elsewhere. Last year, the US Food and Drug Administration issued an approvable letter for the drug under the Zelnorm tradename (Marketletter August 21, 2000), but with the proviso that Novartis and B-MS would have to conduct an additional, confirmatory trial in order to secure full approval. At the time, analysts expressed little surprise in the verdict, noting that out of the three trials submitted to the FDA in support of the application, one showed clear efficacy, the second gave positive results only after the predefined clinical endpoint and the third failed to show a benefit.