Tuesday, February 06, 2007

German Merck says FDA seeks more data on Rebif

Tue Feb 6, 2007 9:41am ET

FRANKFURT, Feb 6 (Reuters) - German Merck KGaA (MRCG.DE: Quote, Profile , Research) said on Tuesday a U.S. regulator has asked for more data on a new formulation of its multiple sclerosis drug Rebif, a move that could delay approval for the drug to come to the market.

"EMD Serono, our U.S. pharma business, has received questions from the FDA that require our response in order for the FDA to continue its review," Phyllis Carter, a Merck spokeswoman, said.

"We continue to work closely with the FDA to address its request and we remain committed to bring in this new formulation of Rebif to the market," Carter added.

Merck inherited Rebif from its recent acquisition of Swiss biotech firm Serono (SERO.VX: Quote, Profile , Research), which filed the application in April last year. The FDA usually decides within 10 months.

Serono was counting on the new Rebif formulations to revive sales in its top selling drug, which were $1.3 billion in 2005.

The company is facing increasing competition in the multiple sclerosis market. U.S. rival Genzyme (GENZ.O: Quote, Profile , Research) said recently that its drug Campath reduced the rate of relapse by a significant amount compared with Rebif.

Shares in Merck rose 2 percent to 92.49 euros by 1425 GMT after Deutsche Bank (DBKGn.DE: Quote, Profile , Research) said its stake in the company had exceeded 20 percent.

The bank, one of Merck's underwriters for its rights issue, later said that the increased stake was the temporary result of Merck's capital increase and the shares will ultimately go to other investors.

Merck was raising more than 2 billion euros ($2.6 billion) to help finance its 11-billion-euro Serono acquisition.

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