) and partner
) announced that their respiratory drug, Anoro Ellipta (once
daily), has been cleared by the Japanese Ministry of Health, Labour
and Welfare (MHLW). The approval was gained for the relief of
symptoms due to airway obstruction in patients suffering from
chronic obstructive pulmonary diseases (COPD) on the basis of
positive data from eight studies (n~6,000).
Anoro Ellipta (an inhaler) is a combination of umeclidinium, a
long-acting muscarinic antagonist and vilanterol a long-acting
beta2 agonist. 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.
Glaxo stated in its press release that Anoro Ellipta is the first
COPD treatment from its portfolio to gain a Japanese approval in
five years. We note that the COPD cocktail treatment is already
approved in the U.S., EU and Canada.
Apart from Anoro Ellipta, the other marketed respiratory product
(emanating from the partnership) is Breo Ellipta. 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 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 concurrent use of inhaled corticosteroid and
long-acting inhaled beta2 agonist is needed. Apart from this, the
candidates under development through this 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
Both Theravance and Glaxo carry 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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