) and partner
) announced positive top-line results from a phase III trial,
DECIDE, on pipeline candidate, daclizumab.
The global, randomized, double-blind, multicenter study was
conducted to evaluate the superiority of daclizumab vis-à-vis
Avonex, as a potential treatment for relapsing-remitting multiple
The results from the study showed that daclizumab was
significantly superior and demonstrated a 45% reduction in ARR
compared to Avonex. We note that the primary endpoint in the DECIDE
study was the reduction in annualized relapse rate (ARR). On the
other hand, although the safety profile of daclizumab in the study
was consistent with what was observed in the prior studies, there
was an increased incidence of serious infections, serious cutaneous
reactions and elevations of liver transaminases in patients treated
with daclizumab compared to Avonex.
Based on encouraging data from the study, both Biogen and AbbVie
intend to work with regulatory agencies and determine appropriate
timelines for filing. The full results from the DECIDE study will
be presented at a conference later.
We note that Biogen holds a strong position in the multiple
sclerosis (MS) market with drugs like Avonex, Tysabri and the
recently launched oral MS treatment, Tecfidera. Tecfidera is off to
a strong start in the U.S. and already holds a leading position in
the oral MS market.
Meanwhile, Biogen is working on further strengthening its
position in the MS market. The company has another candidate,
Plegridy, in its pipeline, being evaluated for relapsing forms of
Biogen recently received a boost when the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency issued a positive opinion for Plegridy.
We believe the successful development and approval of daclizumab
and Plegridy will further strengthen its MS franchise.
Biogen is a Zacks Rank #3 (Hold) stock. Some better-ranked
stocks in the healthcare sector include companies like
Gilead Sciences Inc.
). Both carry a Zacks Rank #1 (Strong Buy).
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