) announced disappointing top-line data from a phase III study on
its chronic coronary heart disease (CHD) candidate, darapladib.
Investors reacted negatively to the news with the stock price
falling approximately 1.6%.
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The randomized, placebo-controlled, double-blind, parallel group,
multi-centre, event-driven STABILITY study (STabilisation of
Atherosclerotic plaque By Initiation of darapLadIb TherapY) is
the first of two phase III studies on darapladib. The STABILITY
study, which enrolled more than 15,000 patients, assessed the use
of darapladib in combination with current standard of care
(statin, aspirin and blood pressure treatments) versus placebo
plus standard of care.
The study failed to meet its primary endpoint. The primary
endpoint was time to first occurrence of any major adverse
cardiovascular event (MACE) including cardiovascular death,
nonfatal myocardial infarction, and nonfatal stroke. Full data
from the STABILITY study will be presented in 2014 at a
Meanwhile, the second phase III study, SOLID-TIMI 52 (n
>13,000), evaluating darapladib in patients suffering from
acute coronary syndrome is expected to be completed in 2014.
Darapladib, which became a part of Glaxo's portfolio through the
Aug 2012 acquisition of Human Genome, was one of the most
interesting late-stage candidates in Glaxo's pipeline. With the
candidate failing in a big study, expectations for success in the
second study, SOLID-TIMI 52, will be low.
Over the last few months Glaxo has suffered quite a few
late-stage pipeline setbacks. In Sep 2013, Glaxo had announced
negative data from a phase III study on drisapersen. Glaxo is
developing drisapersen in collaboration with
) for the treatment of patients suffering from Duchenne muscular
Glaxo's MAGE-A3 cancer immunotherapeutic also failed to meet its
first co-primary endpoint in the phase III DERMA study.
We believe that positive data from the STABILITY study would have
supported regulatory filings and increased Glaxo's chances of
gaining approval for darapladib. This would have provided the
provided a much needed boost to Glaxo's revenues.
Glaxo carries a Zacks Rank #3 (Hold). Right now,
Johnson & Johnson
) look attractive. Both carry a Zacks Rank #2 (Buy).