FDA Panel Backs THRX/GSK Candidate - Analyst Blog

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GlaxoSmithKline ( GSK ) and partner Theravance, Inc. ( THRX ) recently received a boost when the Pulmonary-Allergy Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor (11-2) of approving their candidate UMEC/VI (proposed trade name: Anoro Ellipta).

The companies are looking to get the candidate approved in the U.S. as a maintenance bronchodilator therapy (once daily) to relieve symptoms in adults suffering from chronic obstructive pulmonary disease (COPD). A final decision from the U.S. regulatory body on UMEC/VI's marketing application 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 the EU.

In May 2013, the FDA approved Breo Ellipta, 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 shortly. We are positive on Theravance's pipeline programs in collaboration with Glaxo.

The approval and launch of UMEC/VI along with the launch of Breo Ellipta will help Glaxo make up for the loss of revenues that will arise once Advair, one of its highest revenue grossers, faces generic competition. Advair generated first half 2013 sales of approximately £2.7 billion. The FDA's draft guidance on the generic version of Advair should make it easier for the generics to enter the market.

Glaxo carries a Zacks Rank #3 (Hold). We are pleased with Glaxo's pipeline development efforts. A number of pipeline-related news is expected in the coming quarters. Given the declining sales due to generic competition, we believe Glaxo's pipeline must deliver.

Companies that currently look well-positioned include Actelion Ltd. ( ALIOF ) and Biogen Idec Inc. ( BIIB ) with a Zacks Rank #1 (Strong Buy).



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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: ALIOF , BIIB , GSK , THRX

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