Elan Corporation, plc
) recently announced the publishing of research from the Tysabri
risk management program in the
New England Journal of Medicine
The research was based on data from Tysabri trials,
post-marketing studies and an independent Swedish registry to
estimate the incidence of progressive multifocal
leukoencephalopathy (PML) in patients on Tysabri.
Three risk factors, the presence of anti-JC virus antibody,
prior treatment with immunosuppressants and treatment duration with
Tysabri, were used in the analysis.
Patients with anti-JC virus antibody, who had taken
immunosuppressant therapy before Tysabri and had been on Tysabri
for 25 to 48 months, demonstrated the highest risk of PML. The
number of PML cases in these patients was 11.1 per 1,000
On January 20, 2012, Biogen and Elan announced that the U.S.
Food and Drug Administration (FDA) approved a label change for
Tysabri. As per the updated label, anti-JC virus antibody status is
a risk factor for developing PML, a rare and life-threatening brain
infection. This step will enable doctors to assess the patients'
risk benefit matrix better.
Tysabri is approved in the U.S. for relapsing forms of multiple
sclerosis (MS) in patients who show inadequate response to or are
unable to tolerate other treatments. In the E.U., Tysabri is
approved for highly active relapsing-remitting MS (RRMS) in adult
patients who have severe RRMS or have failed with beta interferon
In the E.U., Tysabri was approved in 2006, while in the U.S.; it
was initially approved in 2004. The product was withdrawn from U.S.
markets in 2005 due to the PML concern. The drug was reintroduced
by Biogen and Elan after a year with a strict warning regarding the
occurrence of PML.
In-market net sales of Tysabri climbed 14.2% to $399 million in
the first quarter of 2012. The increase was driven by higher global
demand and higher price in the U.S. market. The sales of Tysabri
recorded by Elan rose 17.5% to $288.2 million.
We currently have a Neutral recommendation on both Biogen and
Elan. While Elan carries a Zacks #2 Rank (Buy rating) in the short
run, Biogen carries a Zacks #3 Rank (short-term Hold rating).
BIOGEN IDEC INC (BIIB): Free Stock Analysis
ELAN CP PLC ADR (ELN): Free Stock Analysis
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