Theravance, Inc. recently announced encouraging top-line data from a dose-ranging 7-day cross-over design phase IIb study (0091) on its pipeline candidate TD-4208. The randomized, double-blind, multicenter, placebo-controlled study evaluated the bronchodilatory effect, pharmacokinetics, safety and tolerability of the candidate across 6 doses (22, 44, 88, 175, 350 or 700 mcg) in patients suffering from moderate-to-severe chronic obstructive pulmonary disease (COPD).
Data from the study was highly encouraging with the candidate meeting the primary and secondary efficacy endpoints across all doses. The primary efficacy endpoint of the phase IIb study was change from baseline in trough FEV1 (forced expiratory volume in one second) at the end of the 7th day.
Data further revealed that the candidate was well tolerated by the patients across all doses. Moreover, the rates of adverse investments were observed to be identical to placebo.
Though pleased with the data on TD-4208, we believe investor focus will remain on another COPD candidate at Theravance-UMEC/VI (proposed trade name: Anoro Ellipta). The candidate, under review in the U.S., will face a panel of the U.S. Food and Drug Administration (FDA) later this month. A decision from the U.S. regulatory body on UMEC/VI’s new drug application is expected by Dec 18, 2013 (target date). Theravance has co-developed Anoro with GlaxoSmithKline (GSK - Free Report) .
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.
Theravance, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Companies like Gilead Sciences Inc. (GILD - Free Report) and Actelion Ltd. look more attractive in the biopharma space. Both the stocks carry a Zacks Rank #1 (Strong Buy).