May 20, 2005 (The News & Observer - Knight Ridder/Tribune Business News via COMTEX) -- Eleven weeks after Biogen Idec pulled its much-touted multiple sclerosis drug off the market because of health risks, two questions still loom: Will the drug return and how long will the company continue to make it at its Research Triangle Park facility?
So far, there are no clear answers to either.
The first new type of MS drug to become available in years, Tysabri promised new hope for patients and offered blockbuster potential for Biogen Idec. The company hired about 300 in the Triangle last year, a majority of them to manufacture Tysabri.
Now, patients, investors and Biogen Idec employees are waiting for the results of a safety evaluation that will help determine whether Biogen Idec brings the drug back to market.
"Everybody is trying to find out," the status of the drug, said Soham Pandya, an analyst with Susquehanna Financial Group in New York.
Meanwhile, the company's top local official gives carefully guarded answers to questions about whether production of the drug is ongoing.
"We're in a pause mode," said Glen Williams, general manager of Biogen Idec's RTP operations, in a phone interview. "This type of plant you don't just start and stop."
But he did offer a hint of what's to come.
This summer, Biogen Idec plans to test a method to increase the amount of Tysabri the RTP plant can generate without lengthening production time. If the test pans out, because of regulatory requirements, it would take about a year before the method could be used for commercial production.
Production levels of the drug signal the likelihood of Biogen Idec reintroducing it, said Pandya.
That Biogen Idec plans to run the test indicates the company believes there's a good chance Tysabri will return to the market, maybe as early as next year, Pandya said.
"It's a difficult time for the company right now," he said. "But they seem to be doing the right thing."
Biogen Idec took Tysabri off the market Feb. 29 because it was linked to a fatal nervous system disorder. The recall came just two months after Tysabri hit the market and the RTP facility had just started an eight-week production cycle.
While the company wrestles with the drug's future, MS patients remain in limbo.
Lise Cagle worries about the possible side effects of Tysabri, but said she remains interested in whether the company will bring the drug back.
Cagle, who was diagnosed with MS in 1998 and has unsuccessfully tried three of the four older MS drugs, never received her first injection of Tysabri. But next week, the Raleigh woman plans to talk to her neurologist, who had recommended the drug before the recall.
"I want it to be safe, so if I really need something it would be available," Cagle said. "I'm doing really well now and I'm not taking any medication. If I had problems, I'd probably be more anxious for it to come back to the market."
About four months after the Food and Drug Administration approved Tysabri for sale, Biogen Idec received reports about possible side-effects. To date, three cases of progressive multifocal leukoencephalopathy have been confirmed among about 8,000 patients who took Tysabri. Also known as PML, the rare disorder causes mental deterioration, vision loss, paralysis and, within about four months, death.