) recently announced that they have completed the phase III program
for 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 (vilanterol/VI).
The 52-week safety study and two replicate 12-week crossover
exercise studies for LAMA/LABA are now complete. Data from these
studies will be presented at upcoming scientific meetings. Glaxo
remains on track to submit regulatory applications for LAMA/LABA
toward the end of 2012.
Earlier, in July 2012, Glaxo and Theravance had announced data from
four pivotal phase III studies of LAMA/LABA. While two studies
compared the efficacy and safety of LAMA/LABA with VI, UMEC and
placebo, the two other studies compared the efficacy and safety of
) Spiriva. The four studies together enrolled over 4,000 COPD
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.
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 Breo (proposed
brand name Relvar in the EU, formerly known as Relovair) and MABA
Glaxo, in May 2012, 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
We currently have a Neutral recommendation on Theravance, which
carries a Zacks #3 Rank (short-term Hold rating). We, however, have
an Underperform recommendation on Glaxo, which carries a Zacks #4
Rank (short-term Sell rating). Glaxo's second quarter results
missed expectations. The company is facing headwinds like generic
competition and EU pricing pressure.
GLAXOSMITHKLINE (GSK): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
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