Novartis cuts 2007 guidance following US withdrawal of Zelnorm on safety concerns

Swiss pharmaceutical major Novartis sprung a surprise late on March 30, when it announced that, following a request from the US Food and Drug Administration, it would suspend US marketing and sales of Zelnorm (tegaserod maleate), its constipation-predominant irritable bowel syndrome drug.

The product's safety had come into question after Novartis had notified the FDA of a retrospective analysis of data from more than 18,000 patients in the clinical trials database. This showed a small - although not statistically-significant - imbalance in cases of angina pectoris and which was included in the US label when Zelnorm was approved in 2002.

As a result, the company has lowered its financial guidance for 2007, saying that, barring unforeseen events, net sales growth (in local currencies) would be "above 5%," rather than the "mid-to-high single-digit" expansion it had predicted earlier along with reporting its 2006 financial results (Marketletter January 29), and for the pharmaceutical division's turnover to grow at a "low- to mid-single-digit rate."