GlaxoSmithKline
(
GSK
) and
Theravance, Inc.
(
THRX
) recently announced top-line data from pivotal phase III studies
conducted with pipeline candidate, Relovair, for chronic
obstructive pulmonary disease ("COPD") and asthma. Relovair is a
combination of fluticasone furoate and vilanterol.
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.
Relovair was associated with side-effects, such as na
sopharyngitis, upper respiratory tract infection, oral candidiasis,
headache, COPD, back pain, pneumonia, bronchitis and sinusitis. The
candidate was also associated with fatal pneumonia at one dose.
In the asthma studies, Relovair showed an encouraging efficacy
profile but was associated with several side-effects, like
headache, nasopharyngitis, upper respiratory tract infection,
bronchitis, cough, oropharyngeal pain and influenza.
Meanwhile, both Glaxo and Theravance are confident about
Relovair's prospects and feel that the results are adequate for
filing. 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 FDA on requirements
for a filing for the asthma indication of Relovair.
Our Take
With the overall results being mixed, share prices of both Glaxo
and Theravance reacted negatively to the news. Advair is one of
Glaxo's highest revenueearners, generating sales of almost $8
billion in 2010. 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. The FDA could ask the companies for
additional data for the asthma indication.
We currently have Neutral recommendations on both Glaxo and
Theravance. While Glaxo carries a Zacks #3 Rank (hold rating) in
the short run, Theravance carries a Zacks #4 Rank (sell rating) in
the short-term. Theravance has been in the news recently due to
termination of its license, development and commercialization
agreement with Astellas for its only marketed drug Vibativ.
GLAXOSMITHKLINE (
GSK
): Free Stock Analysis Report
THERAVANCE INC (
THRX
): Free Stock Analysis Report
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