Updated March 22, 2002
By LAURA JOHANNES
Staff Reporter of THE WALL STREET JOURNAL
Biogen Inc. vaulted to the top in selling multiple-sclerosis medicine by stressing a simple advantage: Its Avonex drug needed to be injected just once a week, while an older, similar drug from Schering AG required shots every other day.
But now Biogen faces a turnabout. The U.S. Food and Drug Administration has affirmed that higher, more frequent dosing is more effective at treating the disabling disease. As a result, the FDA has allowed yet another competitor, Swiss drug company Serono SA, into the U.S. market.
The Serono entry opens a marketing battle with critical implications for Biogen, which gets 93% of its revenue from Avonex and is one of the few big winners to date in the biotech revolution.
Serono, whose interferon drug is identical to Biogen's but is injected in higher doses three times a week, started dispatching sales representatives immediately after the March 9 approval. "We couldn't wait to get out there," says Deborah Brown, the company's executive vice president in charge of neurology.
Serono will spend $60 million this year pitching Rebif in the U.S. and is aiming for at least 25% market share in four years. It will stress that a head-to-head trial found that 74.9% of patients on Rebif were free from flare-ups of the disease after six months, compared with 63.3% on Avonex. Moreover, those taking Rebif suffered fewer brain lesions.
Biogen declined to give details on its plans for countering the Serono entry. But doctors around the country already have begun getting faxes from Biogen that attempt to poke holes in Serono's data. Serono says it feels its data are very strong.
Biogen said Serono's entrance won't prevent it from achieving its goal of 13% annual sales growth for Avonex through 2005. But analyst Matthew Geller of CIBC World Markets said he expects Avonex sales to rise only 9% this year to $1.07 billion, after soaring 28% last year to $971.6 million world-wide. Prior to Serono's approval, he had predicted a 17% rise.
Biogen does have a new multiple-sclerosis drug in the works, called Antegren, which could tap into a large market of patients who aren't helped by interferon drugs. But Antegren isn't expected to hit the market until 2005.
Initially, Schering had seven-year protection from copycat competition for its interferon drug, Betaseron, under the Orphan Drug Act. Biogen gained access to the market in 1996 after it proved to the FDA that Avonex, similar but not identical to Betaseron, had fewer side effects. Now Rebif, identical to Avonex, has muscled in by showing greater effectiveness; otherwise it would have been blocked until May 2003. Teva Pharmaceutical Industries Ltd., of Israel, sells a completely different MS drug called Copaxone, with about 25% of the market.
Burt Adelman, Biogen's head of research, said Serono's big efficacy advantage persists only for the first six months of the study.
During the second six months, he said, patients on the drugs have about the same number of flare-ups of the disease. "At some point there's a plateau effect" of the higher dose, Dr. Adelman said.
Harder data won't be available for another year, when scientists can measure the two drugs' effectiveness in delaying disability caused by the disease.
In the meantime, if Biogen can raise enough doubts about Rebif's superiority, it hopes many patients will choose the convenience of Avonex.
Biogen also is hitting hard on safety. Trials have shown Avonex takers never get "injection site necrosis," a type of skin damage that occurs in 3% of those taking high-dose Rebif.
Julia Stone, 45 years old, a part-time hairdresser and mother of five from Long Island, recently chose Avonex for its gentleness on the skin and once-a-week schedule, even though her doctor told her that Betaseron would probably benefit her more. Rebif, she said, is also out because of its thrice-weekly schedule and skin effects. "It would be great if they came out with a shot that's only once a month," she said.
An estimated 350,000 patients suffer from multiple sclerosis, which causes fatigue, dizziness and spasticity in muscles that can make walking difficult.
Patients can live symptom-free for months, then have "attacks" where their symptoms grow worse. Some patients grow gradually more disabled after each attack and, in extreme cases, sufferers can become paralyzed.
Both Serono and Biogen have taken early stumbles in their marketing. Last week, a Biogen news release proclaimed that FDA General Counsel Dan Troy had promised to "take enforcement action" if Serono claims its drug is clinically superior. The FDA issued an unusual public denial.
Calling the release "a complete mischaracterization," Mr. Troy said that after Biogen threatened to sue the FDA over the Serono approval, he promised to "personally review" any complaints Biogen had about Serono's marketing, but never promised enforcement action. Biogen counsel Tom Bucknum, who talked to Mr. Troy, agrees with Mr. Troy's version of the conversation but says the news release was intended to convey his confidence that the "FDA would do the right thing" if Serono makes overly broad claims.
Although Rebif was found more effective, Biogen maintains Serono can't use broad terms such as "clinically superior" because Avonex is safer.
Serono, meanwhile, has been told it can't have a corporate presence at next month's meeting of the American Academy of Neurology. Its sin: A May news release incorrectly said that a company-funded presentation on Rebif's superiority over Avonex would occur at an AAN meeting, when, in fact, the presentation was held at an off-site hotel and had nothing to do with the AAN.
Serono said it didn't mean to mislead, and has "fully accepted" AAN's
sanctions, which still allow for its scientists to present their work.
Copyright © 2002 Dow Jones & Company, Inc.