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Suspicion on Biogen combo test.
By John Strahinich and Brett Arends
Tuesday, March 22, 2005 -
Biogen Idec Inc. may have pushed a combination multiple sclerosis treatment using its top drugs - Tysabri and Avonex - to fatten company profits without evidence the two meds were better than Tysabri alone, a leading MS researcher has charged.
The Cambridge biotech giant never tested Tysabri alone against Tysabri and Avonex, relying instead on tests of Tysabri vs. a placebo and Tysabri plus Avonex vs. just Avonex.
``What they should have done was a third arm of that study'' - comparing Tysabri vs. Tysabri with Avonex, Dr. Patricia Coyle, a neurology professor at the State University of New York at Stony Brook, told the Herald.
``Why didn't they do that?'' said Coyle, who also heads the school's MS center. ``From a marketing point of view, that wouldn't have been a good study. You want to sell all your drugs.''
Biogen and its partner, Elan Corp., pulled Tysabri last month after a patient on the combination treatment died of a rare neural disorder and another contracted it.
A Biogen spokeswoman defended the company yesterday.
``The (Tysabri vs. Tysabri plus Avonex) trial was designed for patients on existing therapies who experienced relapses,'' Amy Brockelman said. ``If we were concerned with cannibalizing Avonex, we never would have developed Tysabri.''
Tysabri won fast-track approval from the U.S. Food and Drug Administration in November based on tests showing it cut the rate of MS relapses by 66 percent, compared with Avonex's 30 percent to 40 percent rate. A second Biogen study showed patients on Tysabri and Avonex had 54 percent fewer relapses than those on Avonex alone.
``When you look at those two studies, you would as a doctor use the monotherapy (Tysabri alone), not the combination,'' Coyle said. ``We're talking a lot of money.''
Tysabri costs as much as $30,000 a year, including infusion fees, and Avonex runs about $15,000 a year.
Avonex was Biogen's top seller last year, with $1.42 billion in sales; but some experts estimated Tysabri would have doubled that.
Two other doctors agreed with Coyle's assessment of Tysabri.
``You can't really say that Tysabri plus Avonex was more effective than Tysabri alone,'' said Dr. Ugo Goetzl, who runs the Millennium Clinic in Durham, N.C.
Added Dr. Barry Singer, an MS expert at the Washington University School of Medicine in St. Louis: ``The hard science would have been to do the three-arm trial. Before the recall, I was planning on using Tysabri. There was a lack of evidence that the combination was more effective.''
One analyst thinks Biogen never did the third study ``for commericial reasons.''
``They wanted to protect their franchise (in Avonex),'' said Eric Schmidt, of SG Cowen Securities. ``The easiest way to put a stake in that franchise is to show Tysabri is more effective than Avonex
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