) and partner
) recently received a boost when the Pulmonary-Allergy Drugs
Advisory Committee of the U.S. Food and Drug Administration (FDA)
voted in favor (11-2) of approving their candidate UMEC/VI
(proposed trade name: Anoro Ellipta).
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The companies are looking to get the candidate approved in the
U.S. as a maintenance bronchodilator therapy (once daily) to
relieve symptoms in adults suffering from chronic obstructive
pulmonary disease (COPD). A final decision from the U.S.
regulatory body on UMEC/VI's marketing application is expected by
Dec 18, 2013 (target date).
UMEC/VI 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 candidate is
also under review for the COPD indication in the EU.
In May 2013, the FDA approved 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 shortly. We are positive on Theravance's
pipeline programs in collaboration with Glaxo.
The approval and launch of UMEC/VI along with the launch of Breo
Ellipta will help Glaxo make up for the loss of revenues that
will arise once Advair, one of its highest revenue grossers,
faces generic competition. Advair generated first half 2013 sales
of approximately £2.7 billion. The FDA's draft guidance on the
generic version of Advair should make it easier for the generics
to enter the market.
Glaxo carries a Zacks Rank #3 (Hold). We are pleased with Glaxo's
pipeline development efforts. A number of pipeline-related news
is expected in the coming quarters. Given the declining sales due
to generic competition, we believe Glaxo's pipeline must deliver.
Companies that currently look well-positioned include
Biogen Idec Inc.
) with a Zacks Rank #1 (Strong Buy).