Biogen: 2nd Patient Has Rare Ailment
A second patient has developed a rare and often-fatal neurological condition after taking the multiple sclerosis drug Tysabri, the companies that marketed the drug said Thursday.
Biogen Idec Inc. and Elan Corp. also disclosed that they were cooperating with the Securities and Exchange Commission over matters related to the withdrawal of Tysabri from the market Monday.
Biogen spokesman Tim Hunt said the companies would provide no further details on their contact with the SEC. It was unclear whether the SEC, which couldn’t be reached for comment late Thursday, had launched an investigation or whether the contact was informal.
Biogen, based in Cambridge, Mass., and Elan, based in Dublin, Ireland, pulled Tysabri on Monday after one patient died of progressive multifocal leukoencephalopathy, or PML, an ailment found in patients whose immune systems have been severely compromised. A second patient was suspected of having PML, the companies had said Monday.
The companies reported the confirmation of the second case to the Food and Drug Administration on Thursday, Hunt said. A brain biopsy confirmed the diagnosis, and the patient, like the one who died, had been receiving Tysabri in combination with Avonex, another Biogen drug, for more than two years, he said.
The FDA approved Tysabri in November under an accelerated review program designed to speed breakthrough drugs to market. The agency looked at the first year of data from two clinical trials, which were designed to last two years. The FDA typically needs two years’ worth of data to approve MS drugs.
Experts have said that PML takes several years to develop and was unlikely to turn up in patients who received Tysabri for a short time.
Separately, Biogen was sued Thursday by shareholders for allegedly violating federal securities laws. The suit claims Biogen failed to disclose that Tysabri “posed serious immune-system side effects” so it could “fast-track Tysabri for FDA approval” and financially benefit from sales of the drug.
Biogen and Elan first notified the FDA that two patients were seriously ill Feb. 18, the day after the company issued a positive news release on the results of one of their two-year trials. The second trial has not been completed.
In the days before Feb. 18, high-ranking Biogen insiders sold $15 million in company shares at near-record prices. Biogen’s shares sank 42% and Elan’s shares fell 70% on the day Tysabri was withdrawn.
Biogen and Elan representatives are meeting today with medical experts and representatives of the FDA in what Hunt described as “the first step in what will be an ongoing effort to learn more about PML and its role in MS and the role of Tysabri, if any.” He said the companies were looking for advice on “how to proceed and find a path forward” for the drug.
On Wall Street, however, some analysts were pessimistic about the future of Tysabri.
“I can’t imagine a trial they could conduct” to show Tysabri is safe, said Geoffrey Porges of Sanford Bernstein & Co. Tysabri “is not coming back,” he said.
Biogen’s shares continued to fall on Nasdaq on Thursday, closing at $39.33, off $1.55. Elan’s shares fell $1.29 to $6.65 on the New York Stock Exchange.
