Positive Ph III results for GSK and Theravance Relovair in COPD

UK pharma giant GlaxoSmithKline (LSE: GSK) and development partner Theravance (Nasdaq: THRX) of the USA have released positive results of two pivotal six-month efficacy and safety Phase III studies of Relovair (fluticasone furoate and vilanterol) for patients with chronic obstructive pulmonary disease (COPD). Results of both studies support the continuation of the Relovair development program in the COPD patient population, the companies say.

Relovair is a once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) combination treatment, currently under development for the treatment of COPD and asthma. These data form part of the overall evaluation of the efficacy and safety of the Relovair combination in COPD that, together with data from ongoing 12-month exacerbation studies, will be included in regulatory submissions around the world.

Assuming eventual approval, industry analysts polled by Thomson Reuters believe Relovair should reach the market in 2013 and consensus forecasts point to sales of $1.34 billion by 2015. It will also provide GSK with a useful successor to its blockbuster asthma and COPD drug Advair/Seretide (fluticasone and salmeterol), which is facing patent expiry but still generated sales of £1.22 billion ($1.74 billion) in the first quarter of this year. In what was a clear commitment to the collaboration started in 2002, GSK increased its stake in Theravance to 19% last year (The Pharma Letter November 30, 2010).