The US Food and Drug Administration (FDA) recently released
briefing documents ahead of the review by its Pulmonary-Allergy
Drugs Advisory Committee of the New Drug Application (NDA) of
) candidate FF/VI (furoate/vilanterol, proposed brand name: Breo
Ellipta). The FDA panel is scheduled to review the NDA on Apr 17,
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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). In the briefing documents
posted on the FDA's website, the reviewers stated that the
overall safety data submitted in the NDA was consistent with
In its briefing documents, the FDA has asked the panel to analyze
the risk-benefit profile of the candidate. We remind investors
that the 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
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 #4 (Sell),
reflecting short-term pressure on the stock.
) appears to be more favorably placed in the large-cap pharma
space with a Zacks Rank #2 (Buy).
Theravance, a biopharmaceutical company, carries a Zacks Rank #3
) is more favorably placed in the biopharma space carrying a
Zacks Rank #2.