Serono's Raptiva Swiss Approval Bodes Well
Tuesday March 16, 6:46 am ET
By Anita Greil, Of DOW JONES NEWSWIRES
ZURICH (Dow Jones)--Pharmaceutical company Serono SA said Tuesday the Swiss regulator had approved the sale in Switzerland of its skin disease treatment Raptiva, a move which increases the likelihood of European Union approval.
Raptiva, the first biological therapy for psoriasis to be approved in Switzerland, is designed to provide continuous control of the disease. Patients administer it themselves by injection once a week.
Serono bought Raptiva's worldwide rights, excluding the U.S. and Japan, from Genentech Inc. (NYSE:DNA - News) . It aims to get the treatment for psoriasis - a difficult- to-treat skin disorder characterized by red, scaly and often painful patches - onto the European market by the end of this year.
It filed for approval of the drug with the advisory body of the European Medicines Evaluation Agency - the European Union equivalent of the U.S. Food and Drug Administration (News - Websites) - about a year ago.
Richard Jarvis, analyst at Pictet & Cie., a Geneva-based private bank, said approval could come as early as April, al Serono said it expects the EMEA to decide in the third quarter.
"There is of course always a risk that a drug won't get approval. The reason it's somewhat higher than usual here is that Biogen withdrew its application for psoriasis treatment Amevive when it became clear that the EMEA would reject it," said Jarvis.
Biogen, whose main product is multiple sclerosis treatment Avonex - a prime rival to Serono's key drug Rebif - withdraw its application just over a year ago after the regulator asked for more clinical data.
However, most analysts say that Serono's Raptiva probably has a better safety profile than Amevive. Concerns that the risks tied to Amevive could outweigh its benefits were the likely cause of the EMEA's concern.
The decision by Swissmedic, the Swiss regulatory authority, is backing these assumptions.
"Switzerland is of course just a small market, but this approval should help alleviate worries that the drug won't get approval in the European Union," said Karl Heinz Koch, analyst at Lombard Odier Darier Hentsch, a Geneva-based private bank.
At 1105 GMT, Serono shares were down 0.9% at CHF813.
Estimates for how much revenue Raptiva will generate for Serono in its best year range between $250 million and $500 million.
But while analysts expectations for the medicines' sales potential vary, the all agree that getting Raptiva approved in Europe is important because it reduces Serono's reliance on Rebif for growth.
Company Web Site: serono.com |
