More MS news articles for Oct 2001

Serono seeks U.S. approval for Rebif MS drug

Monday October 8, 4:55 am Eastern Time

GENEVA, Oct 8 (Reuters) - Switzerland's Serono SA , Europe's biggest biotechnology firm, has filed new clinical data with U.S. regulators in a bid to win early approval of its Rebif drug for treating multiple sclerosis, it said on Monday.

Financial markets had eagerly awaited the filing of clinical data with the U.S. Food and Drug Administration that Serono hopes will overturn "orphan" drug exclusivity now enjoyed by Biogen Inc's (NasdaqNM:BGEN - news) Avonex drug in the U.S. market for MS.

Serono shares rose in early trading on the virt-x electronic exchange, the only gainer among Swiss blue chips. The stock was up 0.7 percent at 1,410 Swiss francs at 0825 GMT.

Rebif, a recombinant interferon beta-1a drug that treats the most common form of MS, is registered in 72 countries but not in the United States because of Avonex's protected status. It had global sales of $254.2 million last year.

Serono had previously indicated it would file with the FDA during the third quarter, and investors became increasingly nervous as they awaited announcement of the filing. Serono said on Monday the six-month clinical data was filed before September 30.

A spokesman declined to say when an FDA ruling was likely.

Serono wants to sell Rebif in the key U.S. market in 2002, a year before Avonex's marketing exclusivity runs out automatically in May 2003.

Since the initial presentation in May of results from a head-to-head study of Rebif versus Avonex, Serono shares rallied from around 1,400 francs to more than 1,800 in early July but have since dropped back again.

Financial analysts have taken a wary stance on whether the FDA will accept data from the so-called EVIDENCE study to let Rebif crack the $1 billion U.S. market early.

Biogen argues the EVIDENCE study -- which found Rebif to be more effective than Avonex -- was flawed because trial patients who used Avonex were sicker to start with. Serono denies this.

The two have crossed swords in a Geneva civil court after Serono broke a court order banning the release of the study. Both sides have claimed victory in that case.

In a research note, investment bank UBS Warburg said it remained cautious on whether Rebif will break Avonex's orphan drug status. The orphan drug designation offers protection from competition to encourage companies to develop medicines for relatively rare diseases.

"When Rebif does enter the U.S. market ... we believe that it will be successful. Our 2005 global sales forecast from Rebif is $1.156 billion," it said, reiterating its "buy" rating and 1,800 franc price target.

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