THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING
Tysabri delayed as rivals gird
Biogen's competitors in $5.3b market hope to undermine return of a therapy shown to be more effective than peers
By Jeffrey Krasner, Globe Staff | March 23, 2006
While a decision on whether to bring Tysabri back to the market is on hold, makers of competing multiple sclerosis drugs are already preparing for its return.
With a worldwide market for MS drugs of over $5 billion at stake, they are working on ways to blunt the impact of Tysabri, which has proven twice as effective in preventing debilitating relapses of the disease as existing treatments. The drug, made by Biogen Idec Inc. of Cambridge and Elan Corp. of Ireland, was pulled from the market last year after being linked to a rare but deadly brain disease.
Well before federal advisers this month unanimously decided to recommend that the FDA allow Tysabri to be sold again, Serono SA, the Swiss biopharmaceutical giant, was girding for renewed competition for its MS drug, Rebif.
''We do see a possibility of Tysabri coming back, and we have our own internal battle plan to combat reentry," said chief financial officer Stuart Grant in a recent interview with Dow Jones.
Local officials of Serono, which has US headquarters in Rockland, declined to discuss the plan. But the company sponsored a telephone briefing for science writers about multiple sclerosis a week before the FDA advisory committee meeting. The briefing was cosponsored by Pfizer, which also markets Rebif in the United States.
The phone session was one of a flurry of recent activities involving Tysabri competitors, although the companies said they weren't timed to coincide with the advisory meeting.
Just before the advisory vote, a publicist for Teva Neurosciences Inc. steered reporters to an embargoed scientific paper highlighting potential adverse effects on the immune system caused by Tysabri. Teva is the US arm of an Israeli generic-drug maker, which also manufactures the MS drug Copaxone. It is also sponsoring a series of briefings for physicians on progressive multifocal leukoencephalopathy, or PML, the rare brain disease that was tied to three patients who took Tysabri in clinical trials.
The company did not return phone calls seeking comment.
''Our effort to bring Tysabri back to MS patients is our attempt to provide them with new hope and additional choices," said Biogen Idec spokesman Tim Hunt. ''In contrast, a small number of drug companies are clearly putting corporate profits ahead of patients."
For years, the MS market has been dominated by four drugs. Biogen Idec's Avonex is the leader, with 2005 sales of about $1.5 billion. Serono's Rebif, which is chemically identical to Avonex but has a different dosing regimen, had sales of nearly $1.3 billion. Teva's Copaxone achieved sales of nearly $1.2 billion, and Schering AG's Betaseron reached sales of nearly $1.1 billion last year.
In addition to its unparalleled effectiveness, Tysabri may have an advantage in how it is administered. Patients received Tysabri in a monthly intravenous infusion performed at a doctor's office. The other MS drugs are taken as injections at home, once a week for Avonex and several times a week for the others.
Some analysts expect Tysabri to capture sales from the existing drugs and expand the overall market by attracting patients who have discontinued treatment -- particularly if the drug is approved for first-line treatment, meaning that it could be prescribed before established drugs had been tried. Second-line status would restrict it to patients who aren't responding to other treatments.
According to stockbrokers Rodman & Renshaw, an estimated 26 percent of MS patients take one of the top four treatments now available. The other patients either haven't started treatment, have discontinued treatment because they are unhappy with the results or side effects, or have an aggressive form of MS for which there are no approved treatments.
When Tysabri was on sale between November 2004 and February 2005, Biogen Idec and Elan sold it for about $23,500 for a year's treatment, according to Biogen Idec. Most other MS drugs cost about $20,000 annually. Biogen Idec declined to say what it will charge for Tysabri when it is reintroduced, but some analysts expect it to start at the same price.
Wall Street expected the drug to be a blockbuster, with annual sales of more than $3 billion, but those forecasts were made before it was withdrawn from the market. Biogen Idec and Elan spent much of last year conducting a safety review, which did not uncover any additional cases of the disease. Last fall, they filed an application with the FDA for renewed approval to sell Tysabri.
Mike Luby, chief executive of TargetRX, a Pennsylvania consulting firm specializing in pharmaceutical marketing, said competitors can deal with Tysabri's impending return in three ways.
''The first is to ignore it," Luby said. ''The second is to remind physicians and patients of the uncertainty surrounding the drug. You're not bashing the drug, but there are potentially serious side effects. The third is to position Tysabri in a very narrow niche -- something we call embrace and smother."
Teva, for example, could indirectly be highlighting the risks of Tysabri through its PML calls. Serono seems to be pursuing the third strategy: embrace and smother. In an interview just after the FDA advisory committee's vote, Andrew Galazka, Serono's senior vice president of scientific affairs, called Tysabri a drug of ''last resort."
''Tysabri's risks are not yet well understood," Galazka told Dow Jones.
Before Tysabri's introduction, Serono officials predicted Rebif, which went on sale in the United States in March 2002, would be the biggest-selling MS drug in the country by the end of 2006. But it is still in third place, and the company has now set its sights on becoming number two, Galazka said. Meantime, Serono has put itself up for sale, but has yet to attract a buyer.
Biogen Idec, which relied on the MS drug Avonex for 63 percent of its $2.42 billion in 2005 revenue, said campaigns to dissuade doctors and patients from using Tysabri are attempts by competitors to protect their business.
A doctor who contributed to Teva's PML program and Serono's science-writer call said he isn't trying to promote either drug.
''My intention is to provide a service," said Dr. Bruce Cohen, professor of neurology at the Feinberg School of Medicine at Northwestern University in Chicago. ''I'm not making any attempt to persuade people to take a particular drug or not take a particular drug. Obviously, anything that's sponsored by a pharmaceutical company has a cloud over it in some people's eyes."
Cohen said he accepts speaking fees from Biogen Idec, Serono, Teva, and Schering AG, which markets another MS treatment through its US subsidiary, Berlex.
Jeffrey Krasner can be reached at email@example.com
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