ARTICLE | Clinical News

Theravance falls after Relovair data

January 10, 2012 1:53 AM UTC

Theravance Inc. (NASDAQ:THRX) fell $3.81 (19%) to $16.39 on Monday after it and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) released top-line data from nine trials of Relovair fluticasone furoate/vilanterol to treat chronic obstructive pulmonary disease (COPD) and asthma. GSK is investigating reports of fatal pneumonia at the highest dose of Relovair in two of the trials, a pair of Phase IIIa COPD trials in a total of about 1,620 subjects. In one of the trials, all three doses of Relovair met the primary endpoint of significantly reducing exacerbations at week 52 vs. vilanterol. However, in the other, only the middle dose reached significance.

In a third trial, a Phase IIIa asthma study in 2,000 subjects, Relovair met the primary endpoint of increasing time to first severe exacerbation vs. fluticasone furoate. In two non-pivotal trials for asthma and COPD, respectively, Relovair missed the primary endpoint of superiority to Advair fluticasone propionate/salmeterol on 24-hour weighted mean trough forced expiratory volume in one second (FEV1). Relovair combines an inhaled corticosteroid (ICS) and a long-acting adrenergic receptor beta 2 agonist (LABA). ...