) recently announced the submission of a marketing application to
the European Medicines Agency (EMA) for their pipeline candidate
UMEC/VI (proposed trade name: Anoro). The companies are looking
to get the candidate approved in the EU as a maintenance
bronchodilator therapy (once daily) to relieve symptoms in adults
suffering from chronic obstructive pulmonary disease (COPD).
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Glaxo/Theravance are also seeking US approval of the candidate
for the COPD indication. Last month, the companies announced the
submission of a marketing application with the US Food and Drug
Administration (FDA) seeking approval of UMEC/VI for the COPD
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 note that
Glaxo along with Theravance is also developing other COPD
candidates including Breo (proposed brand name Relvar in the EU,
formerly known as Relovair) and MABA (GSK961081).
We are positive on Theravance's pipeline programs in
collaboration with Glaxo. We are also positive on Theravance's
cardiovascular deal, inked in October 2012, with a big player
Merck & Co., Inc.
Moreover, the deals with Alfa Wassermann and R-Pharm are also
encouraging. Earlier in the month, Theravance and Alfa Wassermann
announced the commencement of a phase II proof-of-concept study
(0093: n~32) to evaluate Theravance's pipeline candidate
velusetrag in patients suffering from diabetic or idiopathic
gastroparesis. Gastroparesis is a disorder of gastrointestinal
We currently have a Neutral recommendation on Glaxo, which
carries a Zacks Rank #3 (Hold). We have a similar stance on
Large-cap pharma companies that currently look better-positioned
). Both companies carry a Zacks Rank #2 (Buy).