Serono gets long-awaited approval for Rebif
Europe's biggest biotechnology company, Serono, has finally got the go ahead to launch its Rebif multiple sclerosis treatment in the United States.
The Geneva-based group called the decision from the US Food and Drugs Administration an important milestone for the company. Serono invested $30 million in the fourth quarter of 2001 to prepare Rebif for sale in the US.
Rebif's launch has been blocked due to the marketing exclusivity of the rival drug, Avonex, made by Biogen. Avonex's orphan drug status runs out in May 2003.
Rebif treats the relapsing form of multiple sclerosis, the most common form of the illness. Multiple sclerosis is a chronic inflammatory condition of the central nervous system and affects about 350,000 people in the US.
Serono scientist, Andrew Galazka, told swissinfo that clinical tests had showen that the new drug was more effective than rival medications.
"It's a beta-interferon [like other treatments], but is a unique formulation in that it enables patients to have higher doses and more frequent administration than other drugs used for treating MS."
More effective than other therapies
He added that the drug had been given FDA approval after a major clinical study conducted by Serono showed the drug to be "more effective in preventing relapses after six months of therapy and reducing the number of brain lesions than the current most widely used therapy in the US".
Tests also showed that the drug was capable of slowing the onset of disability in MS sufferers.
Launching Rebif in the US market raises the prospect of a big boost in Serono's profits.
Serono said on Friday that it expects sales of Rebif to top $1 billion by 2005, with a market share of over 25 per cent.
The drug saw its sales jump 54.1 per cent in local currency terms last year to reach $379.6 million. Serono estimates that it had a fourth quarter market share of 38 per cent outside the US.
Shares in Serono leapt by more than 14 per cent on Friday, more than wiping out a 9.5 per cent decline this year. By the close of trade, the share price had risen to SFr1486.
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