On June 22nd, 2015 the U.S. FDA approved Kengreal (cangrelor), the Medicines Company's intravenous antiplatelet drug for use , as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients in who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. The FDA had previously issued a complete response letter to the Medicines Company in April 2014; the company had since dropped the filing application for bridging patients whose existing antiplatelet regimen must be interrupted for surgery. The drug received approval earlier this year by the EMA in Europe, where it will be marketed as Kengrexal.
The Medicines Company has stated that they expect Kengreal to be available for the U.S. market in July of this year and have proposed a wholesale acquisition cost (WAC) of $749 per treatment. While this price obviously represents a massive price premium over oral antiplatelet agents, it may represent good value in comparison to the price per treatment of the glycoprotein IIb/IIIa inhibitors Integrilin (Merck) and ReoPro (Eli Lilly). The Medicines Company initially plans to target the top centers of excellence for PCI procedures, a strategy that has worked well thus far for their anticoagulant agent, Angiomax.
Decision Resources Group believe that given the unconvincing trial data (i.e., two negative Phase III trials and benefits restricted to improvements in softer end points in the Phase III CHAMPION-PHEONIX trial) which not only has delayed development but also resulted in a knock-back in approval, physicians and payers will need to be convinced on the benefit of using Kengreal over currently available options. A marketing collaboration between The Medicines Company and AstraZeneca may allow for greater penetration to the market (with the use of Kengreal in the acute setting followed by a switch to Brilinta in the chronic setting). In addition, the company's strong presence in the hospital setting should also facilitate uptake. However, we believe that physician familiarity with current treatments, combined with the high price will largely restrict use of Kengreal to a small group of patients. We believe most use may be in ST-segment elevation myocardial infarction (STEMI) patients at risk of stent thrombosis, for whom oral therapy is not a viable option and forecast annual sales of less than $300 million by 2022.
Conor Walsh, M.Sc., Ph.D., is a Senior Director on the Cardiovascular, Metabolic, and Renal Disorders team at Decision Resources Group.