New drug, if OK'd, will be made here
Tuesday, March 11, 2003 12:00AM EST
By David Ranii, Staff Writer
Research Triangle Park
Biogen and its corporate partner have decided to make commercial quantities of the drug they are developing to treat multiple sclerosis and Crohn's disease -- assuming the drug obtains regulatory approval -- at Biogen's manufacturing complex off Davis Drive. The recently constructed $50 million, 42,000-square-foot addition to one of the two manufacturing plants at the site made RTP the logical choice to make the drug Antegren, said Nicolas Barthelemy, vice president of manufacturing and general manager of the RTP operations of Massachusetts-based Biogen.
Biogen has 430 employees in RTP, up from 325 last May, and previously projected that the company's Triangle work force would grow to between 750 and 800 workers by 2007. Biogen hasn't increased those numbers in light of the decision to make Antegren in RTP, but Barthelemy said the projections will be understated if Antegren proves to be a blockbuster.
"That's the baseline. That is being conservative," he said. "It could be a lot more."
Antegren made a splash in early January when the New England Journal of Medicine published promising test results for the drug. Phase II clinical trials found that Antegren cut in half the number of flare-ups of MS symptoms, known as relapses; and it reduced the formation of brain lesions, which correlate to problems with walking that can necessitate using a wheelchair, by about 90 percent. On both fronts, that exceeded the performance of existing MS drugs.
At that time Biogen said there was a good chance that commercial quantities of Antegren would be made at RTP. The company already is making the Antegren used in Phase III clinical trials at RTP.
The new $50 million manufacturing plant addition, which hasn't been approved by the Food and Drug Administration, enables Biogen's second plant to produce two drugs at the same time.
Biogen plans to shorten the development cycle by going straight from producing a clinical supply of the drug to making 15,000-liter batches, skipping the typical intermediate step of making 2,000-liter batches. Each level of production requires FDA approval, which can take six months, Barthelemy said.
Biogen and its corporate partner, Elan, are conducting larger Phase III trials of Antegren involving both MS and Crohn's disease, a severe, chronic gastrointestinal malady that afflicts 1 million people worldwide. Biogen executives anticipate seeking FDA approval to sell Antegren as a treatment for Crohn's early next year; an application for the treatment of MS is expected to be filed in 2005.
Antegren is the most advanced of a new class of drugs known as selective adhesion molecule inhibitors. In MS, immune cells migrate to the brain, where they inflame the myelin sheaths that protect the nerve cells there. Antegren binds itself to adhesion molecules on the surface of the immune cells, apparently inhibiting the immune cells from leaving the bloodstream and migrating to the brain.
Biogen now has two drugs on the market, both of which are made in RTP.
They are the multiple sclerosis drug Avonex and the psoriasis treatment
Amevive, which won FDA approval at the end of January.
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