) and partner
) received a boost with the U.S. Food and Drug Administration
(FDA) approving Anoro Ellipta. The FDA cleared Anoro Ellipta
(once daily) as a long-term maintenance therapy for airflow
obstruction in patients suffering from chronic obstructive
pulmonary disease (COPD) including chronic bronchitis and/or
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Anoro Ellipta 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 U.S. approval of Anoro Ellipta was not surprising considering
that the Pulmonary-Allergy Drugs Advisory Committee recommended
the approval of the drug in Sep 2013. The approval triggers a
milestone payment of $30 million from Theravance to Glaxo. Glaxo
will receive a further payment of $30 million following the
product launch. The launch activities related to Anoro Ellipta
are expected to start from the first quarter of 2014.
We remind investors that in Oct 2013 Glaxo and Theravance had
launched another COPD drug, Breo Ellipta, in the U.S.
Anoro Ellipta and Breo Ellipta, if successfully commercialized,
will compensate for the loss of revenues once Advair - one of
Glaxo's highest revenue grossers - goes generic. The product
generated sales of $3.9 billion in the first nine months of 2013,
accounting for almost 25% of the company's Pharmaceuticals and
Vaccines segment revenues.
Both Glaxo and Theravance carry a Zacks Rank #3 (Hold). Some
better-ranked stocks include
). Both companies hold a Zacks Rank #1 (Strong Buy).