Biogen Idec Inc.
) and partner
) recently submitted applications to the US Food and Drug
Administration (FDA) and European Medicines Agency (EMA) seeking
to update the label of their multiple sclerosis (MS) drugTysabri
The companies are looking to get Tysabri approved as a first
line treatment for patients suffering from certain relapsing
forms of multiple sclerosis (MS) who have tested negative for
antibodies to the JC virus (JCV).
The application is based on risk stratification data. Tysabri
slows disability progression by 42% - 54% and reduces annualized
relapse rates by 68%.
Tysabri is the primary growth driver at Elan. As per Elan,
Tysabri global net sales in the third quarter of 2012 rose 9.8%
to $306.4 million. However, third quarter 2012 Tysabri revenues
at Biogen declined 1% to $275 million.
We note that Tysabri is approved in the US for treating
relapsing forms of multiple sclerosis (MS) in patients who show
inadequate response to or are unable to tolerate other
treatments. In the EU, Tysabri is approved for treating highly
active relapsing-remitting MS (RRMS) in adults who have severe
RRMS or have not responded to beta interferon treatment.
In the EU, Tysabri was approved in 2006 and in the US it was
initially approved in 2004. The product was withdrawn from US
markets in 2005 due to the progressive multifocal
leukoencephalopathy (PML) concern. The drug was reintroduced by
Biogen and Elan after a year with a strict warning regarding the
occurrence of PML.
We currently have a Neutral recommendation on both Biogen and
Elan. While Biogen carries a Zacks Rank #3 (Hold) in the short
run, Elan carries a Zacks Rank #2 (Buy). Right now
) looks more attractive with a Zacks Rank #1 (Strong Buy).
BIOGEN IDEC INC (BIIB): Free Stock Analysis
ELAN CP PLC ADR (ELN): Free Stock Analysis
VALEANT PHARMA (VRX): Free Stock Analysis
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