Glaxo/THRX Seek European Approval

GlaxoSmithKline (GSK - Analyst Report) and Theravance, Inc. (THRX - Analyst Report) 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).

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 indication.

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 like Merck & Co., Inc. (MRK - Analyst Report).

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 motility.

We currently have a Neutral recommendation on Glaxo, which carries a Zacks Rank #3 (Hold). We have a similar stance on Theravance.

Large-cap pharma companies that currently look better-positioned include Sanofi (SNY - Analyst Report) and Novartis (NVS - Snapshot Report). Both companies carry a Zacks Rank #2 (Buy).