Tuesday August 14, 11:50 am Eastern Time
GENEVA, Aug 14 (Reuters) - U.S. biotechnology company Biogen (NasdaqNM:BGEN - news) said on Tuesday it had little to fear from a possible early end to exclusive marketing status in the U.S. for its multiple sclerosis drug Avonex.
Swiss rival Serono , with its MS treatment Rebif, is asking the U.S. Food and Drug Administration (FDA) to end Avonex's U.S. marketing exclusivity before it runs out automatically in May 2003 -- perhaps as soon as mid-2002.
"That's a difference of about 10 months. It won't make a huge difference in terms of revenue and it certainly won't make a big difference to us in terms of competitiveness," Mark Leuchtenberger, vice president of Biogen International, told a media briefing in Geneva.
Biogen said a head-to-head study conducted by Serono 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. That court will decide, probably within the next week, whether Biogen still has a case.
Regardless of that outcome, Biogen intends to proceed with an unfair competition lawsuit and a criminal action alleging contempt of court.
"We are more concerned about the damage which has been done to the perception of Avonex by doctors and patients here in Europe," Leuchtenberger said.
Serono however, believes the actions are simply spoiling tactics.
"Biogen's motivation is clear. Their attacks on Serono are malicious and commercially motivated. At this stage we would not expect anything else from them," a spokesman said, adding Serono stood behind the results of its study. Leuchtenberger reiterated Biogen's confidence in both Avonex and in another upcoming MS drug, Antegren, for which it plans to start an expanded clinical trial later this year.
"We are confident about the pipeline, about Avonex, and by 2003 or 2004 we will have an enormously powerful one-two punch with Antegren," he said.
Avonex is Biogen's sole commercial product so the success of Antegren is vital. Antegren is produced together with Irish pharmaceutical maker Elan Corp Plc (NYSE:ELN - news) and also treats the symptoms of Crohn's disease.