Monday, June 25, 2012

Eliquis given a complete response letter by the USFDA



PFE/BMY drug Eliquis has been given a complete response letter. The complete response was entirely unexpected as it was generally perceived that Eliquis data was best in class. According to BMY the data request is not related to the primary outcome of the study and according to their understanding of the request, they should be able to expeditiously submit the required data.  A 6 month delay is very likely and the delay in approval timelines would impact Eliquis penetration, as Xarelto and Pradaxa would get more lead time in improving their market share. The approval might arrive in close conjunction to announcement of Phase 3 data on Daiichi’s Factor Xa inhibitor – Edoxaban. The Phase 3 data on Edoxaban, if positive, would lead to further rerating of Eliquis sales forecast  in SPAF.. We are likely to see a 10-15% decline in BMY stock price. We also await to see EMA's verdict on Eliquis expected later this year. A negative verdict by EMA would be a big setback