Elan Corporation
(
ELN
) and partner
Biogen Idec
(
BIIB
) recently presented data from 11 company-sponsored Tysabri
(natalizumab) studies at the European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS).
Notably, Biogen and Elan have an agreement for the development
and commercialization of Tysabri. Under the terms of the agreement,
Elan markets the drug in the US and books the entire sales as its
revenues. Outside the US, Biogen is responsible for distribution
and Elan records its share of the profit or loss on these sales of
Tysabri as revenue. This collaboration agreement provides Elan with
the option to buy the rights of Tysabri if Biogen changes
hands.
Important Study Results
Elan and Biogen presented positive results from Tysabri
Observational Program (TOP), which is evaluating the long-term
safety and efficacy of the drug along with two-year freedom from
clinical disease activity in patients suffering from multiple
sclerosis (MS).
The companies also presented results from the TYNERGY trial of
Tysabri. The results from this study showed that Tysabri treatment
resulted in a significant reduction in fatigue. Moreover it also
helped in improving the health-related quality of life (HRQoL).
Elan and Biogen also declared positive results from the AFFIRM
study of Tysabri. The results showed that 37% of the patients
treated with Tysabri were free of clinical and radiological disease
activity over the study period.
Our Take and Recommendation
Tysabri is the principal growth driver at Elan. As per Elan,
Tysabri global net sales in the second quarter of 2012 were $395.5
million. We note that Tysabri is approved in the US for 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 highly active relapsing-remitting MS (RRMS)
in adult patients who have severe RRMS or have failed with beta
interferon treatment.
In the EU, Tysabri was approved in 2006, while 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 The product was withdrawn from US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 #2 Rank (Buy rating) in the
short run, Elan carries a Zacks #3 Rank (short-term Hold
rating).
BIOGEN IDEC INC (BIIB): Free Stock Analysis
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ELAN CP PLC ADR (ELN): Free Stock Analysis
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