Novartis and Bristol-Myers Squibb committed to obtaining marketing approval for Zelmac in Europe

01-Jun-2001

Novartis and Bristol-Myers Squibb Company announced today that they are voluntarily withdrawing the marketing application for tegaserod (Zelmac) from the European Agency for the Evaluation of Medicinal Products (EMEA) and are considering options for resubmission. The companies were seeking marketing authorization for this new treatment in irritable bowel syndrome (IBS).

This decision resulted from a difference of opinion with the Committee for Proprietary Medicinal Products (CPMP) regarding the relevance of the observed clinical effect. There was also disagreement over the methodological conduct of some preclinical studies.

"Novartis and Bristol-Myers Squibb will continue to work together to make Zelmac available in Europe," said Thomas Ebeling, CEO of Novartis Pharma AG. "There is a great unmet clinical need for an effective treatment for patients with IBS and we believe Zelmac offers significant hope to the millions of patients who remain untreated."

"IBS is a chronic disorder that can have a dramatically negative impact on patients' daily lives and well-being. IBS represents a significant healthcare cost to the economy and remains the second leading cause of workplace absenteeism after the common cold," said Richard J. Lane, Executive Vice President and President Worldwide Medicines Group, Bristol-Myers Squibb.

Marketing approval is pending in the United States, where this IBS treatment is known by the brand name ZelnormTM. The US Food and Drug Administration (FDA) issued an approvable letter for Zelnorm on 11 August 2000.

IBS is estimated to affect up to 20% of the population. The multiple symptoms of IBS include abdominal pain/discomfort, bloating, and constipation. The symptoms can vary between patients.

Zelmac is one of a new class of drug and the first selective 5HT4 receptor partial agonist in development for the treatment of abdominal pain/discomfort, bloating, and constipation in female patients with IBS. In clinical trials involving more than 4500 patients, Zelmac has been shown to reduce (p<0.05) abdominal pain/discomfort, bloating and constipation in female patients with IBS. In these trials, Zelmac was well tolerated with an adverse event profile similar to that of placebo, with the exception of mild and transient diarrhea and headache. All these events were self-limiting and did not require additional treatment or hospitalisation.

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