Some uncertainty was added to what appeared to be an imminentapproval and launch of Biogen Inc.'s multiple sclerosis drug Fridaywhen Berlex Laboratories Inc. filed a suit against the FDA.

Berlex, of Wayne, N.J., markets Betaseron, a beta interferondeveloped by Chiron Corp. and the product that stands to lose themost if Avonex is approved. Avonex, or interferon beta-1a, wasunanimously recommended for approval by an FDA advisory panelon Dec. 4, 1995. (See BioWorld Today, Dec. 5, 1995, p. 1.)

Berlex sued in U.S. District Court in the District of Columbia,claiming that FDA approval of Avonex would violate the orphandrug status of Betaseron and violate the agency's own proceduresregarding manufacturing changes. Betaseron sales have been morethan $300 million per year in the U.S. While the market might growwith Avonex approval, analysts expect the new product would garnerat least half of it.

Berlex said in a news release that the drug the FDA is ready toapprove has not been tested in multiple sclerosis patients. Biogeninitially used a product manufactured in Germany for its trials.

Kathryn Bloom, director of communications for Biogen, said theFDA has deemed that the cell lines for the product manufactured inGermany are comparable to those used now, in Cambridge, tomanufacture Avonex. She told BioWorld Today the new product wasused in an extension study involving more than 300 patients.

Biogen, of Cambridge, Mass., said Friday in a news release that thesuit is "completely without merit. Berlex has known for some timethe competitive challenge Avonex will pose to its Betaseron product.Apparently they have chosen to try to substitute the courtroom for themarketplace as the competitive arena. We do not expect this actionwill in any way impede our making Avonex available to multiplesclerosis patients, and we are fully confident that the FDA willprevail in court and we will prevail in the market."

C. Anthony Butler, an analyst at Raymond James & Associates Inc.,in St. Petersburg, Fla., agreed with Biogen. He said he's beenresearching the issues surrounding the competing drugs for about ayear and concluded "there is a low probability for this suit to beupheld."

The Orphan Drug Act gives drugs that address small patientpopulations a period of exclusivity from copycat drugs. Butler saidAvonex and Betaseron clearly have different molecular structures andAvonex has demonstrated clinical superiority, in terms of dosingadvantages, fewer side effects and delaying disease progression.

The Berlex suit also claims violations of the AdministrativeProcedures Act. That charge relates to purported differences in theproduct that was used in clinical trials vs. the product that will beused in the market.

Butler said bioequivalency has been demonstrated between theclinical lots used for testing and those used to support the new drugapplication. "I still have Biogen rolling out [Avonex] in May," Butlersaid.

Bloom said, "We're not changing any estimates based on this."Biogen has maintained that approval was expected in the first half ofthe year and launch would follow shortly afterward.

David Stone, an analyst at New York-based Cowen & Co., said theissue is not as clear-cut as it may appear, and that the lawsuit "addssome uncertainty to the timing of [Avonex]."

"The Orphan Drug Act is a politically created piece of legislation,high on spirit and short on science and economics. How a judge isgoing to rule, I don't know. This particular issue has not been tested,so it's difficult to say how its going to come out."

Stone pointed out that the question of whether the drugs are different,taking the most conservative position, cannot be determined untilthey have been compared head-to-head. Adding to that thedifferences in drug formulations and routes of administration, onecould say Avonex was not proved more efficacious; rather it was acase of the trial being more successful, Stone said.

Bloom said a hearing is expected this week in which a judge willdetermine whether a temporary restraining order is issued against theFDA.

Biogen's stock (NASDAQ:BGEN) lost $1.50 Friday to close at $61per share. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.