) and partner
) are seeking to expand the label of their respiratory drug, Breo
Ellipta, in the U.S.
To that end, the companies announced the submission of a
supplemental New Drug Application for the drug (once a day) to the
FDA for treating patients (aged above 12 years) suffering from
asthma. Approval has been sought for Breo Ellipta as a combination
therapy (fixed-dose) across two doses - 100/25mcg and 200/25mcg.
The companies are seeking to expand the drug's label on the basis
of encouraging data from a comprehensive clinical development
program for the asthma indication.
We remind investors that the FDA cleared Breo Ellipta in May 2013
as a long-term maintenance therapy of airflow obstruction and for
bringing down exacerbations in patients suffering from chronic
obstructive pulmonary disease (COPD). In the event of the drug
receiving clearance for the asthma indication, its sales potential
would be boosted significantly. The drug is also approved in the EU
(trade name: Relvar Ellipta) for asthma and COPD.
Another approved respiratory product under Theravance's partnership
with Glaxo is Anoro Ellipta. The drug is available for the COPD
indication. Theravance receives royalties from Glaxo on these two
respiratory products. Furthermore, the respiratory candidates
developed by the companies hold great promise.
We remind investors that Theravance had split into two independent,
listed companies last month. While Theravance, Inc., a royalty
management company, deals with products/candidates under the Glaxo
) focuses on the discovery, development and commercialization of
small-molecule therapies targeted towards areas of high unmet
Theravance carries a Zacks Rank #3 (Hold). A better-ranked stock in
the healthcare space is
), sporting a Zacks Rank #1 (Strong Buy).
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