Unlike the HCV battle where GILD had more than a year of first-to-market status, Praluent will only have a month of such status assuming REGN/SNY can capitalize on that extra time to quickly bring it to the US market faster than AMGN . However, Repatha is expected to hit the EU market sooner, so it's a fair tradeoff as both will be able to get some good traction.
Additional difference could be in the pricing strategy of Praluent being cheaper due to lower dosing, however Repatha has a slightly higher efficacy (61% vs 56% Praluent) and has noted a possible 50% reduction in cardiovascular disease. If AMGN is able to prove these claims with a large post-marketing study, Repatha will have a significant advantage due to the added secondary benefit and can easily command a higher price point.
Important Repatha Dates:
June 10 ADCOM
Aug 27 PDUFA
Important Praluent Dates:
June 9 ADCOM
July 24 PDUFA
MM's taking this down to $157 is a bargain given the strength of the company's overall pipeline. At the very least, we should see some action heading into the ADCOM dates and both drugs are expected to easily get positive recommendations. has already given positive recommendations for both drugs in May. approval for Repatha is expected in September, shortly after the FDA approval.
Check out this article from yesterday. Great in-depth analysis. http://seekingalpha.com/article/3259585-amgen-regeneron-ldl-lowering-drugs-provide-major-upside-potential-to-their-stocks
PS. It wasn't an approval, rather a recommendation. In all likelihood FDA will approve both drugs, but restrict the label initially to statin-resistant patients until the CVOT results come in 2017, possibly more interim results next year. Given preliminary results and the ADCOM discussions, Repatha seems to have the edge to get the expanded label first.