Replies to post #121498 on Biotech Values

[DewDiligence]

GSK/THRX—Relovair (“Son of Advair”) phase-3 data are murky:

http://finance.yahoo.com/news/GSK-Theravance-Announce-iw-2127190283.html?x=0

The COPD programme included two replicate 52-week exacerbation studies each of which randomized approximately 1,620 patients. The studies were powered to compare each of 3 doses of FF/VI (200/25mcg, 100/25mcg and 50/25mcg) to VI 25mcg alone in a step-wise manner, starting at the highest dose. In both studies, all doses of FF/VI demonstrated reductions in the annual rate of moderate to severe exacerbations compared with VI alone. In the first study, the reductions were statistically significant at all doses (200/25mcg p < 0.001, 100/25mcg p=0.024, 50/25mcg p=0.040). In the second study, the reductions were not statistically significant at the highest dose (200/25mcg) [nor at the lowest dose]. The p-values in this study were p=0.109 (200/25mcg), p < 0.001 (100/25mcg) and p=0.181 (50/25mcg). GSK and Theravance believe that it is appropriate to request that regulatory authorities review the totality of the exacerbation data, including the effects seen across both studies for the 100/25mcg dose.

The PR says that 2012 submissions to the FDA and EMA will definitely be made in COPD, but only the EMA submission is a definite in asthma.