) recently announced the submission of regulatory applications for
their pipeline candidate, Breo (proposed brand name Relvar in the
EU, formerly known as Relovair). Breo is a combination of
fluticasone furoate and vilanterol, administered using a dry powder
inhaler called Ellipta. Regulatory applications for the chronic
obstructive pulmonary disease (COPD) indication were submitted in
both the US and EU. In the EU, a regulatory application for asthma
was also submitted.
The COPD application in the US relates to the approval of Breo
as long-term maintenance treatment of airflow obstruction in COPD
patients, including chronic bronchitis and/or emphysema and to
reduce exacerbations of COPD in patients with an exacerbation
history. Glaxo and Theravance are finalizing the strategy for the
US regulatory filing for the asthma indication.
The EU submission for the COPD indication relates to the
symptomatic treatment of COPD in patients with a FEV1 <70%
predicted normal (post-bronchodilator) and who have a history of
Earlier in March 2012, Glaxo and Theravance had announced the
completion of the registrational program for Breo. They reported
results from two non-pivotal 12 week phase III COPD studies with
approximately 500 patients each. The studies compared once daily
Breo with twice daily Advair. In the first study, Breo demonstrated
superiority over Advair (combination of fluticasone propionate and
salmeterol) and met the primary end point. However, in the second
study, the improvements were not statistically significant.
The companies also completed the phase III Breo registrational
program for the treatment of persistent asthma in adults and
adolescents. Positive results were reported from a study evaluating
the efficacy and safety of fluticasone furoate and fluticasone
propionate compared to placebo.
Breo, 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 LAMA/LABA (UMEC/VI)
and MABA (GSK961081).
Earlier in May 2012, Glaxo had acquired 10,000,000 shares of
Theravance for approximately $21.2887 per share, increasing 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. While Theravance carries a Zacks #2 Rank (Buy rating)
in the short run, Glaxo carries a Zacks #4 Rank (Sell rating) in
the short run.
GLAXOSMITHKLINE (GSK): Free Stock Analysis
THERAVANCE INC (THRX): Free Stock Analysis
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