) and partner
) announced the commencement of a phase III study (IMPACT:
n=10,000) to evaluate the safety and efficacy of a triple
combination treatment in patients suffering from chronic
obstructive pulmonary disease (COPD). The double-blind, three-arm,
parallel group, 52-week study is evaluating the combination of an
inhaled corticosteroid (fluticasone furoate), a long-acting
muscarinic antagonist (umeclidinium) and a long-acting
beta2-adrenergic agonist (vilanterol) in COPD patients.
The IMPACT study is the first in a program designed to evaluate the
triple combination in patients suffering from this chronic
respiratory ailment. The study is designed to assess whether
treatment with the above combination can bring down the annual rate
of moderate and severe exacerbations compared with the marketed
COPD treatments, Relvar/Breo Ellipta and Anoro Ellipta. While
Relvar/Breo Ellipta is a combination of an inhaled corticosteroid
and a long-acting beta2-adrenergic agonist, Anoro Ellipta is a
combination of a long-acting muscarinic antagonist and a
long-acting beta2 agonist.
Theravance and Glaxo were in the news recently when Anoro Ellipta
was approved in Japan for the relief of symptoms due to airway
obstruction in COPD patients. The COPD treatment will be launched
in Japan by Sep 30, 2014. The Japanese approval triggered a payment
of $10 million from Theravance to Glaxo. The collaboration between
the two companies was inked in 2002. We note that Anoro Ellipta is
already approved in the U.S., EU and Canada.
Breo Ellipta was cleared by the FDA in May 2013 as a long-term
maintenance therapy of airflow obstruction and for bringing down
exacerbations in patients suffering from COPD. The drug is also
available in Canada for the COPD indication. The treatment is also
approved in the EU (trade name: Relvar Ellipta) for asthma and
COPD. Relvar Ellipta is available in Japan for treating patients
suffering from bronchial asthma where a concurrent use of inhaled
corticosteroid and long-acting inhaled beta2 agonist is needed.
Apart from Anoro Ellipta and Breo Ellipta, the candidates under
development through the Glaxo/Theravance partnership also hold
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
Glaxo carries a Zacks Rank #4 (Sell) while Theravance is a Zacks
Ranked #2 (Buy) stock. A better-ranked stock in the healthcare
), sporting a Zacks Rank #1 (Strong Buy).
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