) continues to progress well with the development of its
psoriasis candidate, secukinumab (AIN457).
The company reported encouraging top-line data from a phase
III study, FIXTURE (the Full year Investigative eXamination of
secukinumab vs. eTanercept Using 2 dosing Regimens to determine
Efficacy in psoriasis), on secukinumab in Jul 2013.
Novartis is now out with positive results from the FIXTURE
study. It was observed from the randomized double-blind,
placebo-controlled study (n =1,306) that secukinumab showed
improved efficacy to
) Enbrel in patients suffering from moderate-to-severe plaque
We note that the phase III study met both primary and key
secondary endpoints. The results showed that secukinumab was more
effective in clearing skin faster with a long lasting effect than
Novartis also presented data from an additional phase III
study, SCULPTURE (StudyComparing secukinumab Use in Long-term
Psoriasis maintenance therapy: fixed regimens vs reTreatment Upon
start of RElapse), on secukinumab. The data from the study also
showed efficacy of secukinumab dosed at monthly intervals.
We note that secukinumab is one of the most promising pipeline
candidates at Novartis and we are encouraged by the results from
the FIXTURE study. Novartis remains on track to file for approval
of the candidate in the EU and the U.S. later in 2013.
We note that secukinumab is also being evaluated for other
indications such as psoriatic arthritis, ankylosing spondylitis
and rheumatoid arthritis among others. The phase III studies for
these indications are ongoing with results expected in 2014.
Additionally, secukinumab is in phase II studies for the
treatment of multiple sclerosis.
Secukinumab is the first anti IL-17A on which phase III
results have been presented. We note that Amgen has an anti IL-17
candidate, brodalumab, in its pipeline. Brodalumab is currently
in phase III studies for the psoriasis indication.
Meanwhile, currently approved products include
) Humira among others.
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) looks well placed with a Zacks Rank #1 (Strong Buy).
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