GlaxoSmithKline
(
GSK
) and
Theravance, Inc.
(
THRX
) recently announced top-line data from phase III studies conducted
with their pipeline candidate, Relovair, for chronic obstructive
pulmonary disease (COPD) and asthma. Relovair is a combination of
fluticasone furoate and vilanterol. The companies also announced
that they have completed the registrational program for Relovair
and the full results from these studies will be presented at
upcoming scientific meetings.
Glaxo and Theravance reported results from two non-pivotal 12
week phase III COPD studies with approximately 500 patients each.
The studies compared once daily Relovair with twice daily Advair.
In the first study, Relovair 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 Relovair
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.
Meanwhile, both Glaxo and Theravance are confident about
Relovair's prospects and remain on-track for regulatory filings.
Glaxo plans to submit marketing applications to the regulatory
bodies in the US and Europe in mid-2012 for the COPD
indication.
For the asthma indication, the company plans to seek EU approval
in mid-2012. Glaxo remains in talks with the US Food and Drug
Administration (FDA) on requirements for a filing for the asthma
indication of Relovair.
Earlier in January 2012, GlaxoSmithKline and Theravance had
announced initial outcomes from pivotal phase III studies of
Relovair. In the two COPD studies, Relovair reduced the annual rate
of moderate-to-severe exacerbations (worsening of severity of
disease) compared to vilanterol. However, in the second study, the
reductions were not statistically significant at the highest dose.
In the asthma studies, Relovair showed an encouraging efficacy
profile.
Our Take
Advair is one of Glaxo's highest revenue earners, generating
sales of more than £5 billion in 2011. Relovair, if approved, will
be positioned as a replacement for Advair. In light of the mixed
results from the studies, we remain cautious about the chances of
Relovair gaining first-round approval.
We currently have Neutral recommendations on both Glaxo and
Theravance. Both the stocks carry a Zacks #3 Rank (Hold rating) in
the short run.
GLAXOSMITHKLINE (
GSK
): Free Stock Analysis Report
THERAVANCE INC (
THRX
): Free Stock Analysis Report
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