) recently announced data from four pivotal phase III studies
conducted with their pipeline candidate, LAMA/LABA (UMEC/VI), for
chronic obstructive pulmonary disease (COPD). LAMA/LABA is a
combination of a long-acting muscarinic antagonist/LAMA (GSK573719
or umeclidinium bromide/UMEC) and a long-acting beta2 agonist/LABA
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While two studies compared the efficacy and safety of LAMA/LABA
with VI, UMEC and placebo, the other two other studies compared the
efficacy and safety of LAMA/LABA with
) Spiriva. Spiriva is commonly used as a maintenance treatment for
COPD. The four studies together enrolled over 4,000 COPD patients.
In both the placebo-controlled, 24-week, randomized, double-blind
studies, LAMA/LABA showed a statistically significant benefit over
VI, UMEC and placebo. In the first head-to-head comparison with
Spiriva, LAMA/LABA showed a statistically significant improvement.
However, in the second study, LAMA/LABA failed to do so although it
demonstrated numerical difference.
Currently, a 52-week safety study and two replicate 12-week
crossover exercise studies are ongoing for LAMA/LABA. Glaxo plans
to submit regulatory applications for LAMA/LABA towards the end of
LAMA/LABA, if approved, will be positioned as a replacement for
Advair, one of Glaxo's highest revenue earners with 2011 sales
exceeding £5 billion. We note that Glaxo along with Theravance is
also developing other COPD candidates including Relovair and MABA
Earlier in May 2012, Glaxo had acquired 10,000,000 shares of
Theravance for approximately $21.2887 per share. With this
transaction, Glaxo increased its holding in Theravance to 26.7%
from 18.3%. The increased holding by Glaxo reflects its confidence
in the pipeline candidates.
We currently have Neutral recommendations on both Glaxo and
Theravance. Both the stocks carry a Zacks #3 Rank (Hold rating) in
the short run.