Glaxo/Theravance Seek US Approval

GlaxoSmithKline ( GSK - Analyst Report ) and partner Theravance, Inc. ( THRX - Analyst Report ) 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 - Analyst Report ) and Bayer ( BAYRY - Analyst Report ) . Both carry a Zacks Rank #2 (Buy).