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Theravance, Inc. (THRX - Analyst Report) announced recently that the Pulmonary-Allergy Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the New Drug Application (NDA) filed for UMEC/VI (proposed trade name: Anoro Ellipta) on Sep 10, 2013. Theravance has co-developed Anoro with GlaxoSmithKline (GSK - Analyst Report).

The companies are looking to get the candidate approved in the U.S. as a once daily therapy for treating patients suffering from chronic obstructive pulmonary disease (COPD). A decision from the U.S. regulatory body on UMEC/VI’s 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). The candidate is also under review for the COPD indication in Japan and the EU.

In May 2013, Theravance received a boost when the FDA approved Breo Ellipta, also co-developed with Glaxo, as a long-term maintenance therapy of airflow obstruction and for bringing down exacerbations in patients suffering from COPD. Breo Ellipta is expected to be available from the third/fourth quarter of 2013. We are positive on Theravance’s pipeline programs in collaboration with Glaxo.

We remind investors that in Apr 2013, the board of directors at Theravance approved its decision to split into two separate publicly traded companies. While one company will manage the late-stage partnered respiratory candidates and associated potential royalty revenues, the other will focus on the discovery, development and commercialization of small-molecule therapies targeted towards areas of high unmet medical need.

The company responsible for the development of respiratory candidates will be named Royalty Management Company. The entity dealing with small-molecule therapies will be named Theravance Biopharma.

Theravance, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Companies like Gilead Sciences Inc. (GILD - Analyst Report) and Actelion Ltd. (ALIOF) look more attractive in the biopharma space. Both the stocks carry a Zacks Rank #1 (Strong Buy).

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