) and partner
) recently received a boost when the Pulmonary-Allergy Drugs
Advisory Committee of the US Food and Drug Administration (FDA)
voted in favor of approving their candidate FF/VI
(furoate/vilanterol, proposed brand name: Breo Ellipta).
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The companies are looking to get the candidate approved as a
long-term, maintenance therapy of airflow obstruction and for
bringing down exacerbations in patients suffering from chronic
obstructive pulmonary disease (COPD). Nine of the thirteen panel
members voted in favor of approval of the candidate for the above
indication. Moreover, the candidate was also recommended
(by a similar majority) as a treatment for the reduction of COPD
exacerbations in patients having a history of exacerbations.
We remind investors that the New Drug Application (NDA) was
accepted for review by the FDA in Sep 2012. A final decision from
the US regulatory body is expected by May 12, 2013. Although the
FDA is not bound to accept the recommendation of the advisory
panel it does pay heed when reviewing new drug applications. We
note that the candidate is under review for the COPD and asthma
indications (proposed trade name: Relvar).
We note that Glaxo and Theravance are also looking to get another
COPD candidate approved. In Feb 2013, the FDA accepted the
regulatory application of Glaxo/Theravance's UMEC/VI (proposed
trade name: Anoro). The companies are looking to get the
candidate approved in the US as a once daily therapy for treating
patients suffering from COPD. A decision from the US regulatory
body on UMEC/VI's NDA is expected by Dec 18, 2013.
We are positive on Theravance's pipeline programs in
collaboration with Glaxo. We note that Glaxo has a robust
pipeline. A number of pipeline-related news is in fact expected
in the coming quarters. Given the declining sales from generic
competition, we believe Glaxo's pipeline must deliver.
Glaxo, a large cap pharma stock, carries a Zacks Rank #3 (Hold).
We have a similar stance on Theravance, a biopharmaceutical
company. Stocks such as
Gilead Sciences, Inc.
) appear to be more favorably placed in the biopharma space. Both
stocks carry a Zacks Rank #2 (Buy).