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NJ Drugmaker Berlex Sues Biogen in Dispute over Multiple Sclerosis Drugs

July 4, 1996

NEWARK, N.J. (AP) _ In the latest skirmish over their competing medicines for victims of Multiple Sclerosis, Berlex Laboratories Inc. on Wednesday accused Biogen Inc. of infringing on a key patent for producing the drug.

Berlex Laboratories Inc., of Wayne, N.J., contended in a federal lawsuit that Biogen is using its patented process for making beta interferon, a protein produced by the immune system to fight infection by viruses.

Biogen, based in Cambridge, Mass., responded that the lawsuit, filed in U.S. District Court, is ``completely without merit and another desperate attempt to keep″ Biogen’s new Avonex drug off the market.

The Berlex lawsuit ultimately seeks to have Avonex sales halted, but is not demanding an immediate injunction.

Avonex, the first drug to slow the progression of MS, was approved May 17 by the U.S. Food and Drug Administration. Berlex’s drug Betaseron, which

Betaseron is based on a protein called interferon beta-1b and is slightly different from Avonex, which is based on interferon beta-1a.

At stake is the $500 million to $700 million in annual sales worldwide that analysts predict Avonex will garner, well over double Betaseron’s sales.

In its latest lawsuit, Berlex asserted that Avonex gets its interferon from the same process _ using the ovary cells of Chinese hamsters _ that Berlex uses in Beneferon, a new drug that Berlex said has been clinically validated to treat MS.

``Because Avonex was approved and given orphan drug designation, Beneferon cannot come on the market,″ Berlex spokeswoman Wendy Neininger said.

In a lawsuit filed in April against the FDA, Berlex itself cited the federal Orphan Drug Act, which gives companies a financial reward for developing drugs for rare diseases.

In that lawsuit, filed in Washington, D.C., Berlex contended that Avonex is so similar to Betaseron that its approval would violate the seven-year period of exclusive marketing rights granted to Betaseron under the act.

A judge rejected the request, saying it was premature prior to Avonex’s approval.

The FDA moved Wednesday to have that lawsuit dismissed, a motion that will be joined by Biogen, said James R. Tobin, Biogen president and chief executive officer.

Berlex, a subsidiary of the German drugmaker Schering AG, maintains that dismissal would be premature and will argue for its action to continue, Neininger said.

In addition, Biogen on May 3 filed a lawsuit seeking to have the Berlex patent declared invalid in U.S. District Court in Boston.

``We think the patent wasn’t valid in the first place, and even if it was, because we know what we’re doing and they don’t, it doesn’t infringe,″ Tobin said. Biogen’s process is similar, but ``different enough,″ he said Wednesday.

MS is a chronic inflammatory disease of the central nervous system which slowly disrupts nerve impulses, causing weakness, loss of coordination, vision and speech problems and, in severe cases, paralysis.

It typically strikes young adults, between the ages of 20 and 40, about two-thirds of them women. There are about 250,000 MS patients in the United States, roughly half of whom have the variety of the disease that Avonex and Betaseron are designed to help.

Avonex has milder side effects and is more effective than Betaseron in slowing the disease’s progression, tests showed. Avonex is injected into muscle once a week while Betaseron is injected just below the skin every other day.

Betaseron was found to slow the frequency of paralyzing MS flare-ups. Its side effects include fever and achiness. Sales haven’t met the expectations of financial analysts.

Biogen has said the wholesale price of Avonex will be about $710 for a four-week supply. Betaseron’s wholesale price is about $1,000 for the same period. Drugstores charge about a 15 percent markup, on average, but the final price depends on a patient’s insurance coverage.

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