More MS news articles for Mar 2002

Change in status for MS drug wonít faze Biogen

03/25/2002 08:29 AM
By Adria Cimino

Although the Food and Drug Administrationís approval of Seronoís Rebif wasnít the best news for Biogen, it is hardly a catastrophe.

The FDA recently broke through the Orphan Drug status held by Biogenís Avonex, allowing the Swiss competitor into the U.S. market.

Both drugs are interferon treatments for multiple sclerosis, but their means of administration and dosage frequency are not the same.

Of course, Avonex is a $1 billion drug and represents the lionís share of Biogenís revenue, but that still doesnít mean the FDA decision will change the future of Biogen.

The reason?

Avonexís Orphan Drug status was set to expire next year. The FDA action just eliminated one year of market exclusivity.

With all of the scaling up and sales efforts Serono must initiate in the United States, it seems unlikely that its drug could do immense damage to Biogenís market share in just one year.

Whether Orphan status was lost this year or next year, Biogen would find itself in pretty much the same situation.

James Mullen, Biogen president and chief executive officer, recently spoke about the outcome at SG Cowenís annual health care conference in Boston.

ďThe FDA decision certainly was unfortunate,Ē he said. ďItís a very narrow decision. Itís not good for the Orphan Drug (program).Ē

But Mullen said that Biogen already had been planning for Orphan Drug expiration. It has ramped up the U.S. sales force by 30 percent to a total of 85 sales representatives in the field.

The company is launching its competitive strategy a year early and was fully prepared to do so, Mullen said.

He wouldnít give any other details on how Biogen would remain ahead of Serono in the U.S. market, but apparently the Cambridge-based company has not had much of a problem in Europe, where the two drugs have been competing for years.

Avonex holds 35 percent of the European market, while Rebif has 28 percent. Other treatments make up the rest of the total.

Mullen said that Biogenís top goal is ďto keep these people out of wheelchairs, and weíve got the strongest data on that.Ē

The FDA says it will break a companyís Orphan Drug status to let a competitor into the market if the competitorís drug is more efficacious. It sounds simple and clear-cut, but it isnít.

Rebif shows a benefit in the relapse rate at 24 weeks.

Seronoís study comparing the two drugs, showed that 75 percent of Rebif patients did not have a relapse; the number was 63 percent for Avonex patients.

Rebif, however, does not demonstrate this kind of benefit after six months of treatment.

Biogen argues that in spite of the early advantage of Rebif, Avonex provides a long-term safety and efficacy record.

Mullen said that Avonex is associated with a low occurrence of neutralizing antibodies, which lead to decreased drug efficacy.

Rebif patients developed these antibodies at a 12-fold higher rate than Avonex patients in Seronoís study comparing the two drugs.

Avonex patients also developed fewer injection-site reactions and had zero percent occurrence of tissue injury, while Rebif patients had a 3 percent incidence of tissue injury.

Dr. Burt Adelman, Biogenís vice president of medical research, said now that all the data from Seronoís head-to-head trial is available, the marketplace will decide which drug will prevail in the United States.

Biogen expects the percentage of prescriptions for Avonex and Rebif should begin to show doctorsí reactions in the coming months.

The FDAís decision did not seem to be much of a surprise for Biogen executives, who appeared ready to roll out the companyís new strategy immediately.

Losing Orphan Drug status was a disappointment and drove Biogen stock prices down somewhat, but one canít help but think that the event was a mere hiccup in the Biogen story.

The company has been preparing for this day for quite a while and is focusing efforts on two other products ó one for multiple sclerosis and the other for psoriasis.

Rebifís entry into the U.S. market is good news for Serono. And for Biogen, the news isnít as bad as one might initially think.

Adria Cimino reports on biotechnology and medical devices.

Copyright Mass High Tech 2000