Repatha (AMGN) and Praluent (Regeneron (REGN)/Sinofy (SNY)) are two PCSK9 inhibitors, a new class of drugs to treat hypercholesterolemia more effectively than previously possible. This will trigger a HCV-like battle between the two as both have high efficacy. Both have room to share the market, allowing both to make a significant amount of money on these blockbuster drugs.
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. EMA has already given positive recommendations for both drugs in May. EMA approval for Repatha is expected in September, shortly after the FDA approval.
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. EMA has already given positive recommendations for both drugs in May. EMA approval for Repatha is expected in September, shortly after the FDA approval.