Wednesday March 6, 2:54 PM EST
By Toni Clarke
NEW YORK, March 6 (Reuters) - U.S. regulators could decide any day now whether to allow Swiss-based Serono SA to sell a multiple sclerosis drug in the United States that would break the monopoly of Biogen Inc.'s rival drug Avonex.
If approved, Serono's drug, Rebif, could take as much as 20 percent market share from Avonex, which is protected from competition until May 2003 under a rule designed to promote the development of drugs for small disease populations.
Serono (SEOZ) is seeking to persuade regulators to overturn Avonex's protected status. To do so it must prove that Rebif is either more effective or safer than Avonex.
At stake is access to a market currently worth $1.2 billion. Biogen (BGEN) claims nearly 60 percent of the market. U.S. sales of Avonex were about $711 million in 2001.
Serono tried unsuccessfully to break into the United States with Rebif in 1999. Now it is hoping data from a new trial will persuade the U.S. Food and Drug Administration to rule in its favor.
The six-month trial, conducted by Serono, directly pitted Rebif against Avonex. Serono claims the results show Rebif is more effective. Biogen argues the trial wasn't properly blinded, meaning patients knew which drug they were getting. That could make the results too subjective, Biogen says.
Analysts are divided over Serono's chances of success.
"Without having the benefit of a full review by independent sources it's very hard to know to what extent one should rely on Serono's interpretation of Serono's data," said Ira Loss, a senior vice president at research firm Washington Analysis.
"Companies tend to put a very positive interpretation on their own analysis and very often that interpretation doesn't stand up when reviewed by an independent group such as the FDA."
Serono says it expects the FDA to rule this month on whether to accept Rebif or reject it. Regulators could also decide to accept it on the condition the company provides additional information.
Carolyn Castel, a Serono spokeswoman, said the FDA is obliged by its regulations to respond to Serono's application by a certain date this month. She declined to give the date.
The FDA canceled an advisory panel meeting scheduled for Feb. 15 at which panel members would have made a recommendation to the FDA on the drug. The agency gave no reason for the cancellation.
Rebif is already sold outside the United States and Biogen says it expects Rebif to eventually be approved here too. But it argues Serono's latest data are too nebulous to justify the claim that Rebif is superior to Avonex.
"We are hoping the FDA maintains its high scientific standards and fairly evaluates the clinical data before it," said Kathleen O'Donnell, a Biogen spokeswoman.
Earlier today, Biogen said a European regulatory committee recommended that Avonex's use be extended to include patients in early stages of multiple sclerosis.
The recommendation is a key step on the way to winning approval from the European Commission, which typically follows the committee's advice.
If approved, Avonex, which is currently approved for use in patients who experience two or more separate symptoms associated with multiple sclerosis, could be prescribed for patients showing just one symptom. These could include numbness in the arms or legs, muscular problems or certain eye complaints.
Biogen has also filed in the United States for approval to market the drug for earlier stage treatment and expects a decision in the first half of this year.
Worldwide sales of Avonex reached
$972 million in 2001. Biogen said last November it estimates that the global
market for multiple sclerosis treatments will top $4 billion by 2005.
©2001 Reuters Limited