The FDA Friday approved Biogen's Avonex, giving multiplesclerosis patients a second drug to treat their debilitating progressivedisease which disrupts the brain's nerve impulses and interferes witha variety of activities, including movement, speech, vision and short-term memory.
Clearance of the drug, which was recommended for approval by anadvisory panel in December 1995, pushed Cambridge, Mass.-basedBiogen's stock (NASDAQ:BGEN) up 50 cents to close at $65.50, a 1percent increase on trading of more than two million shares.
The slight gain, analysts observed, reflected investors' expectationsfor an FDA approval. The company's stock jumped 12 percentfollowing the positive review of the new drug application by thePeripheral and Central Nervous System Drugs Advisory Committee.And shares increased another 10 percent over the last six months inanticipation of Friday's news.
Biogen officials said Avonex, or interferon-beta 1a, will be availabletoday at a wholesale price of $710 for a four-week supply. Thetreatment is expected to cost each patient at least $8,500 per year.
The pricing, said analyst David Stone, of Cowen and Co. in Boston,is in line with the only competing drug on the U.S. market formultiple sclerosis, Betaseron, which is sold by Berlex LaboratoriesInc., of Wayne, N.J., and manufactured by Chiron Corp., ofEmeryville, Calif. Berlex is a subsidiary of Schering AG, of Berlin.
Cost is not the only similarity between the drugs. Avonex andBetaseron, which is interferon-beta 1b, are nearly the same molecule.The precise mechanism of action is not known.
Both drugs are approved for relapsing and remitting multiplesclerosis, which affects about 50 percent of the 250,000 people in theU.S. afflicted with the disorder. The other 50 percent experience asteady decline with few remission periods.
Neither drug is a cure. In the inflammatory disease, a patient's ownimmune system attacks and destroys the myelin sheath protecting thecentral nervous system's nerve fibers, which carry the brain's signalsto the body.
However, clinical trials of Avonex demonstrated it can slowprogression of the disease and reduce flare-ups. Betaseron showed itcould reduce relapses, but fell short of proving it could slow thedisorder's deteriorating march.
Symptoms of the disease include loss of motor coordination,impaired vision, slurred speech, tremors, fatigue, short-term memoryloss and eventual paralysis.
Among the differences in the two products are administration.Avonex is taken once a week compared with daily injections ofBetaseron. The former also is given intramuscularly, making it easierfor self-administration than the latter. And among the adversereactions associated with Betaseron is injection site irritation, whichwas not a problem with Avonex.
Both products have similar side effects, which include flu-likesymptoms.
Stone said the two drugs likely will split the U.S. market. Betaseron,which was approved in July 1993, has annual sales of about $225million. It is not yet on the market in Europe.
He estimated sales of Avonex _ the first product marketed by Biogen_ at $75 million for the remainder of this year and $325 million fornext. The 1997 total, Stone said, will include some European sales.Biogen officials have said they expect to begin selling Avonex inEurope in the first quarter of 1997.
The marketplace will not be the only venue of competition forAvonex and Betaseron. Berlex unsuccessfully tried to stop the FDAfrom clearing Biogen's product earlier this month by filing a lawsuitin U.S. District Court, contending an Avonex approval would violateBetaseron's orphan drug status and other FDA policies. The courtrejected Berlex's request for a temporary restraining order againstBiogen, saying the company would have to wait until the FDA actedto litigate the case. (See BioWorld Today, April 29 and May 1, 1996,p. 1.)
Berlex's officials said Friday they will head back to court and seek apreliminary injunction to stop Avonex sales. Biogen officialspredicted the challenge will not succeed.
Berlex and Biogen also could end up in court in a patent dispute.Berlex's parent, Schering, has suggested Avonex may violate its U.S.patent for Betaseron. On the other hand, Biogen has said Betaseronmay violate its patent for Avonex in Europe. Rather than fight eachother over patents, analysts have said the two may negotiate cross-license agreements. However, neither company has conceded itsproduct violates any patents.
Biogen officials Friday celebrated the prospect of bringing their firstproduct to market themselves.
In a conference call with analysts, Chairman and CEO James Vincentsaid the company has been waiting for this day since Biogen wasfounded 18 years ago.
Although Biogen is one of biotechnology's top-tier companies, itsrevenues have been derived mostly from royalties on drugs licensedto pharmaceutical firms.
Now, Stone said, the focus on Biogen shifts more toward its ownearnings strength. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.