Thirteen was a good number for
Biogen Idec (Nasdaq: BIIB) and
Elan (NYSE: ELN).
Twenty-three? Not so much.
That's the number of progressive multifocal
leukoencephalopathy (PML) cases that both the European
Medicines Agency and the Food and Drug Administration
acknowledged have been reported for patients on the
companies' multiple sclerosis drug, Tysabri, since it was put
back on the market more than two years ago.
The FDA previously said there were 13 cases of the
potentially deadly brain infection reported through Sept. 8,
so it seems there have been 10 new cases reported since then.
Seven weeks doesn't make a trend, but it's still startling
nonetheless.
The true rate of PML is very important for the sales of
Tysabri. The drug works better than other multiple sclerosis
drugs such as
Teva Pharmaceutical 's (Nasdaq: TEVA)
Copaxone,
Novartis ' (NYSE: NVS) Extavia, and Rebif
from
Pfizer (NYSE: PFE) and EMD Serono. But
patients are only going to use it if the risk of PML is low
enough to justify the added benefit.
The European agency has "started a review of the benefits
and risks of Tysabri." That might result in tighter
prescribing information, but I doubt it'll result in Tysabri
being pulled from the market.
Stricter prescribing information might not be the worst
thing. Of the first 11 cases -- before Biogen stopped
reporting individual cases -- eight were from outside the
U.S. even though there were more patients on Tysabri in the
U.S. than elsewhere. That may mean that the Touch program in
the U.S., which regulates who gets the drug, may be working.
If stricter prescriptions result in a lower PML rate, that's
good long-term news for Biogen and Elan, even if it means
some impact on sales in the near term.
After Friday's beatdown, are the two companies good
values? It's hard to know because it's difficult to
predict how patients and doctors are going to react to the
news. Investors might be better off sitting on the sidelines,
at least long enough to see how the prescriptions hold up
before jumping in.
Are Elan and Biogen values or value traps at these
levels? Let us know in the comments section below.
This article was originally published as
For Tysabri, 23 Is 10 Too Manyon
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