A report from BioPharm Insight noted that a patient who had taken
Biogen's new multiple sclerosis drug Tecfidera had died, prompting a
quick drop of about 3% in the biotech group's stock price, which
recovered to about even later in the day.
A Biogen spokeswoman
told Reuters that the death of the 59-year-old woman occurred two weeks
after she stopped taking Tecfidera because of gastrointestinal problems.
The MS patient had suffered from a form of pneumonia prior to her
death. The news service reported that the death was unrelated to the GI
problems, and the company said that it is "unlikely" that Tecfidera
caused the fatal case.
The
drama underscores the high visibility of Tecfidera, for which analysts
have projected eventual peak sales of more than $3 billion. As long as
the safety profile of the therapy remains within an acceptable range,
Tecfidera could become the best-selling drug in the growing class of
oral MS drugs, which includes such meds as Aubagio from Sanofi ($SNY)
and Novartis' ($NVS) Gilenya.
ISI analyst Mark
Schoenebaum wrote to investors that he viewed the death as a "non-issue"
for the company's performance. The company told the top analyst that it
is "still gathering info" on the case.
Tecfidera is
perhaps the most anticipated drug from the Weston, MA-based biotech
heavyweight since the launch of the MS therapy Tysabri, which the FDA
initially approved in November 2004.
Tysabri was
reintroduced in 2006 and has gone on to become a blockbuster drug, with
tests now available to assess the risk of PML prior to treatment. Yet
the issue showed how it can take a long time to dig out from a safety
problem with a new drug.
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An
FDA advisory panel recently recommended the approval of Sanofi's
multiple sclerosis drug, Lemtrada. However, that approval came among
some mixed and contradictory opinions about the drug and the efficacy of
Sanofi's trials.
