Glaxo/Theravance Seek US Approval


GlaxoSmithKline (GSK) and partner Theravance, Inc. (THRX) recently announced that the US Food and Drug Administration (:FDA) has accepted the regulatory application of 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 chronic obstructive pulmonary disease (:COPD). A decision from the US regulatory body on UMEC/VI’s New Drug Application (:NDA) is expected by Dec 18, 2013 (target date).

UMEC/VI is a combination of a long-acting muscarinic antagonist/LAMA (GSK573719 or umeclidinium bromide/UMEC) and a long-acting beta2 agonist/LABA (vilanterol/VI).

We remind investors that the companies are also looking to get UMEC/VI approved in the EU for use in COPD patients. The European Medicines Agency (:EMA) has validated the Marketing Authorization Application (MAA) for the candidate. Glaxo remains on track to submit regulatory applications for UMEC/VI in other countries in 2013.

We note that Glaxo along with Theravance is also developing other COPD candidates including FF/VI (furoate/vilanterol, proposed brand name Relvar in the EU and Breo in the US, formerly known as Relovair) and MABA (bifunctional muscarinic antagonist-beta2 agonist, GSK961081).

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 expected in the coming quarters. We believe that Glaxo’s pipeline must deliver since many of its products are facing declining sales due to generic competition.

Glaxo carries a Zacks Rank #4 (Sell) in the short run. Large-cap pharma companies that currently look better-positioned include Eli Lilly and Company (LLY) and Bayer (BAYRY). Both carry a Zacks Rank #2 (Buy).

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