Zelnorm fails to win EU panel backing
12/21/05 11:25 AM
Novartis bowel drug fails to win EU panel backing
By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON (Reuters) - A panel of experts decided on Thursday not to recommend Novartis AG's Zelnorm drug for irritable bowel syndrome in the European Union, hitting the company's shares and prompting it to launch an appeal.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted the negative opinion following a review which began in October last year.
Novartis said it would appeal the medical experts' decision, which blocks EU approval for the drug as a treatment for women with constipation related to irritable bowel syndrome.
Shares in Novartis fell 1.7 percent to 67.15 Swiss francs on the setback for a medicine that has taken longer to become a major seller than the Swiss drugs giant originally expected.
Novartis pointed out the drug was already on sale in the United States and many other countries, and said it remained committed to ensuring it became available to women in Europe.
"Although we are disappointed with the CHMP opinion, we are confident in the clinical profile and benefits of Zelnorm," James Shannon, head of global pharmaceuticals development at Novartis, said in a statement.
Zelnorm -- which is also known as Zelmac in some countries -- was approved by the U.S. Food and Drug Administration in 2002 for use in women with constipation relating to IBS.
However, safety information was added to Zelnorm's packaging in the United States in 2004, warning of the effects of diarrhoea and alerting patients to a condition where blood flow to the intestines is reduced.
"It's had a bit of a chequered history," said Mike Ward, an analyst with stockbroker Code Securities. "I think ultimately it will do reasonably well but it has been a long, hard struggle for them to get there."
The drug is sold in more than 56 countries as a treatment of IBS-C, or constipation resulting from irritable bowel syndrome, and in more than 20 countries as a treatment for chronic constipation. Worldwide sales were $299 million last year.
Recommendations from the agency's committee are normally endorsed by the European Commission within 90 days.