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Swiss reject Roche's Tarceva for pancreatic cancer

Thu Mar 29, 2007 10:05am EDT

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(Adds refiling of drug, more details, trims)

ZURICH, March 29 (Reuters) - Swiss health authorities have rejected drugmaker Roche Holding AG's (ROG.VX) Tarceva for use in pancreatic cancer, the company said on Thursday.

"We've actually applied for the approval and they said no," said Roche spokeswoman Martina Rupp. "It's definitely not good news for patients in Switzerland."

Rupp said Switzerland's regulatory agency, Swissmedic, had questioned the safety and efficacy of Tarceva and the approval process had not got as far as the pricing of the drug.

It is the second time Switzerland has turned down approval of Tarceva in pancreatic cancer.

Roche has already refiled its application, based on prior approvals of the drug in the European Union and United States, and is waiting on a response from Swissmedic, Rupp said.

Dresdner Kleinwort analysts said potential sales in Switzerland for pancreatic cancer were too small to have a major impact, but the news "is a mild negative for sentiment."

Roche participation certificates, its most widely traded form of equity, were 0.6 percent higher at 215.50 Swiss francs by 1254 GMT, just behind the Swiss blue chip SMI index.

((Reporting by Sam Cage, editing by Rory Channing;

Email: zurich.newsroom@reuters.com

Reuters Messaging:

sam.cage.reuters.com@reuters.net

Telephone: +41 (0) 44 631 7457)) Keywords: ROCHE TARCEVA/

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