As expected, the FDA granted Biogen Inc. a new label indication for the multiple sclerosis drug Avonex (interferon beta-1a), allowing it to be prescribed for treatment of patients after the first MS attack, if a brain scan shows abnormalities typical of the disease.
"We'd been expecting this for time," said Amy McKnight, associate director of public affairs for Cambridge, Mass.-based Biogen. "Now it's official."
Martin Auster, analyst with SunTrust Robinson Humphrey in Atlanta, said physicians already were using Avonex that way - prescribing it at the first onset of symptoms - and the agency's action probably won't have much affect on sales.
"Does anyone thinks this helps at all?" he said, although he allowed that "you've got to differentiate in front of the doctor, and it doesn't hurt to say, We're the only ones approved for the first attack of MS.'"
The FDA's approval of the new indication (which Avonex won in Europe last year) was based on a three-year, Phase III trial of 383 patients considered at high risk of developing MS because of a recently experienced isolated demyelinating event involving the optic nerve, spinal cord or brainstem/cerebellum, and lesions typical of MS visible on magnetic resonance imaging of the brain.
Results from the study were published in the New England Journal of Medicine in September 2000. With the primary endpoint being time from the first to the second MS attack, Avonex-treated patients showed a 44 percent decrease in the rate of second attack as compared to placebo.
In the hard-fought MS battle for market share, Biogen less than a week ago disclosed that it was paying another $55 million to Berlin-based Schering AG to settle a longstanding court dispute over beta-interferon. (See BioWorld Today, Feb. 4, 2003.)
Biogen earlier paid $20 million to Schering subsidiary Berlex Laboratories Inc., of Richmond, Calif., to settle the patent argument related to Schering's MS drug Betaseron (interferon beta 1-b). Biogen got a royalty-free, nonexclusive license to the patents held by Berlex.
Other MS drugs are Geneva, Switzerland-based Serono SA's Rebif (interferon beta 1-a) and Copaxone (glatiramer acetate for injection), from Jerusalem-based Teva Pharmaceuticals Industries Ltd.
Those, like Biogen's Avonex, are being used after the first MS attack already, Auster said.
"People realize that you need to treat early and aggressively," he told BioWorld Today. "The perception at the doctor level is that they pick their poison. Rebif is a little more potent, but I don't think you'll find anyone who will say I think only Biogen works after the first attack."
Also this month, the FDA gave approval to Biogen's Amevive (alefacept) for psoriasis, which selectively targets the CD45RO+ subset of T cells, and a lot of people are really hopeful about Antegren, "but it's too early to be too confident," Auster said. (See BioWorld Today, Feb. 3, 2003.)
Antegren (natalizumab), an alpha 4 integrin inhibitor, is in development with Elan Corp. plc, of Dublin, Ireland.
"We just entered Phase III," McKnight told BioWorld Today, estimating the trials for Crohn's disease will finish in 2004 and the trials for MS will conclude in 2005.
Auster said "you really have to believe in Amevive to buy [Biogen] now," adding that "at some point the company is definitely a takeover candidate." He declined to speculate on a buyer but said it likely would be a large concern "that already has a foothold in neurology."
Biogen's stock (NASDAQ:BGEN) closed Friday at $39.88, down 10 cents.