I agree Rojospan, one of the best Q&A sessions yet given by Vertex execs with the analysts. CMO Bob Kauffman was particularly effective in his addressing in a credible and reassuring manner the ongoing VX 135 program and the facts surrounding the apparent efficacy and safety so far in the 100 mg and 200 mg treatment groups, as well as the reversible elevation of LFTs, resolving in just one week, seen in the three patients in the discontinued 400 mg arm of the VX135/RBV study in Europe. Given the importance of the safety data in the remaining 100 and 200mg dose arms, these results to be released, perhaps in time for AASLD, will be the next hurdle for VX 135. But if safety in the lower doses is proven, with sufficient efficacy, count on rapid progression of VX 135 combination studies with BMY and JNJ's compounds to give Gilead some competition, given the size of the hep C market worldwide.
With regard to CF, the announcement of a new 4 week trial using 661 and 770 in 551/508 heterozygotes is a very exciting proof of concept study to expand the potential CF treatment population to include heterozygotes and get further clinical experience using 661 with 770 to garner sufficient safety and efficacy data to move it into pivotal trials like VX 809. Lastly, expansion of Kalydeco into the EU, Canada and Australia has nearly doubled Kalydeco revenue in just one quarter! Expansion of the monotherapy label to other gating and residual CFTR function mutations and the 2 to 6 year olds in all monotherapy treatable mutations will result in a three fold increase in Kalydeco revenue by next year, and with a positive read out of phase three trials testing VX 809 with 770 in 508 homozygotes, sixty five percent of the world wide CF population could be approved for treatment with Vertex drugs by the end of 2014. And this does not even count potential revenue from partnering VX 509 and 787. Things are looking positive thanks to the strong VRTX R&D pipeline.