) and partner
) recently announced that their chronic obstructive pulmonary
disease (COPD) candidate, Breo Ellipta has received US Food and
Drug Administration (FDA) approval.
The FDA cleared Breo Ellipta as a long-term maintenance
therapy of airflow obstruction and for bringing down
exacerbations in patients suffering from COPD. Breo Ellipta is
expected to be available from the third quarter of 2013.
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The FDA approval did not come as a surprise, as last month the
FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted in
favor (9-4) of clearing Breo Ellipta in the US.
As per the existing agreement between Glaxo and Theravance, the
approval of Breo Ellipta triggered a milestone payment of $30
million from Theravance.
We note that Glaxo and Theravance are also looking to get another
COPD candidate approved. In Feb 2013, the FDA accepted the
regulatory application of Glaxo/Theravance's Anoro. The companies
are looking to get the candidate approved in the US as a once
daily therapy for treating patients suffering from COPD. A
decision from the US regulatory body on Anoro's marketing
application is expected by Dec 18, 2013.
We are positive on Theravance's pipeline programs in
collaboration with Glaxo. We note that Glaxo has a robust
pipeline. A number of pipeline-related news is in fact expected
in the coming quarters. Given the declining sales from generic
competition, we believe Glaxo's pipeline must deliver.
Glaxo carries a Zacks Rank #3 (Hold) in the short run. Companies
that currently look attractive include
Catalyst Pharmaceuticals Partners Inc.
). Both carry a Zacks Rank #1 (Strong Buy).