More MS news articles for Dec 2001

FDA panel cancels Rebif review, Serono stock slips

http://biz.yahoo.com/rf/011221/l21445602_1.html

Friday December 21, 7:11 am Eastern Time

ZURICH, Dec 21 (Reuters) - The U.S. Food and Drug Administration has cancelled an advisory panel review of Serono's multiple sclerosis drug Rebif planned for February, sending the firm's stock lower on Friday.

But Europe's largest biotechnology company said it remained "cautiously optimistic" that it could still launch Rebif in the big U.S. market next year.

"The FDA has confirmed the cancellation of the FDA advisory committee and they didn't give us any real explanation but we feel quite comfortable with this news because they reassured us that the proceeding is following the right schedule and we are following the regular steps and timing," a spokesman said.

"We had a long conversation with the FDA and they assured us there is no cause for concern."

Stock in Europe's biggest biotech firm, which had risen on news that the FDA panel planned to review Rebif on February 15, fell nearly seven percent to a one-week low of 1,285 Swiss francs before recovering to 1,346, down 2.5 percent, around 1155

Gmt.

The Serono spokesman said no other FDA review panel was planned, but added this was not a cause for concern.

"We are cautiously optimistic on the timing, but we can't speculate on when we are going to have an answer from the FDA," he said.

Serono is trying to overturn "orphan drug" marketing exclusivity now enjoyed in the billion-dollar U.S. market by rival multiple sclerosis drug Avonex, made by Biogen Inc (NasdaqNM:BGEN - news). Avonex's protection runs to May 2003.

Financial analysts said Serono's stock could remain volatile until the mystery of why the panel was dropped was settled.

"In our view, Serono stock is likely to be weak on the back of this news, but we would view this as a long-term buying opportunity," UBS Warburg said in a research note, noting Serono trades at a discount to its global peers and has a $1.5 billion war chest for acquisitions.

It said the FDA panel news was disappointing but did not change the underlying picture for Serono, for which it has a "buy" recommendation.

Schroder Salomon Smith Barney reiterated its "neutral, high-risk" rating for Serono, noting it was not certain that the company would be able to overturn Avonex's protection.

If Serono succeeds, however, it could add 100 Swiss francs to the share price on purely fundamental factors and give the stock an extra boost from the positive sentiment generated.
 

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