UPDATE 4-Novartis pulls Zelnorm in U.S., cuts 2007 outlook
(Recasts; adds FDA comments, background, closing share price)
ZURICH, March 30 (Reuters) - Novartis (NOVN.VX) pulled bowel drug Zelnorm from U.S. shelves on Friday at the request of regulators because clinical trial data indicated a possible link to heart attacks and strokes.
The move is a body blow to the drug, a treatment for irritable bowel syndrome which previously had run into safety issues and never been approved for use in Europe, and it prompted Novartis to cut its 2007 sales forecast.
The Swiss drugmaker said the U.S. Food and Drug Administration had asked it to suspend marketing and sales to permit further discussion of benefits and risks of the medicine.
FDA officials said Zelnorm might be able to return on a limited basis but only if a group of patients could be identified for whom the benefits outweighed the risks.
Zelnorm was Novartis's 12th-biggest selling drug in 2006, with global turnover growing 30 percent to $561 million, of which $488 million was generated in the United States.
About 500,000 U.S. patients are taking Zelnorm, Novartis spokeswoman Anna Frable said.
Novartis shares (NVS.N) fell $2.26, or nearly 4 percent, to close at $54.63 on the New York Stock Exchange.
"This news is obviously quite a surprise, involving a medium-size product for Novartis that was expected to have annual sales of $1 billion by 2012," said Shaojing Tong, an analyst with Mehta Partners in New York.
"Although it's a setback, I don't think it will hurt Novartis to a great extent because overall it is a fairly solid company," he added.
Prudential Equity analyst Tim Anderson said Zelnorm's loss could lop around 2 percent off 2007 earnings per share. There was also a risk of product liability lawsuits, although this would be largely immaterial to a company of Novartis' size, he said.
The withdrawal was prompted by an analysis of data on more than 18,000 patients. It found the incidence of serious and life-threatening cardiovascular problems in those on Zelnorm was 0.11 percent against 0.01 percent for those given a placebo, Novartis said.
The FDA said one of the 13 affected patients in the Zelnorm group had died. Of those taking placebo, only one had symptoms suggesting the beginning of a stroke, which went away without complication.
"We have not proven causality," Dr. John Jenkins, director of the FDA's Office of New Drugs, told reporters. But he said the difference between the groups was "very concerning" and enough to warrant the drug's recall.
Novartis told the FDA on February 22 about preliminary findings of cardiovascular problems, Jenkins said. After requesting more data and doing its own review, the FDA asked Novartis to withdraw the drug on March 28. Continued...
