January 17, 2019
BIOINVEST NEWS: Esperion (ESPR)
Nets $150 Million in Deal For Europe With Daiichi Sankyo Europe
ESPR entered into a substantial licensing agreement with Daiichi Sankyo Europe (DSE) providing DSE with exclusive rights to commercialize bempedoic acid (BA) and the bempedoic acid/ezetimibe combination pill in the European Economic Area and Switzerland. Under the terms of the licensing agreement, Esperion will grant Daiichi Sankyo Europe exclusive commercialization rights to bempedoic acid and the bempedoic acid/ezetimibe combination pill in the European Economic Area and Switzerland. Daiichi Sankyo Europe will be responsible for commercialization in the territories. ESPR will receive an upfront cash payment of $150 million as well as $150 million upon the first commercial sales in the territory. ESPR is also eligible to receive a substantial additional regulatory milestone payment upon the grant of the Marketing Authorization in the EU for the CV Risk Reduction Label, depending on the range of relative risk reduction in the CLEAR Outcomes study. In addition, ESPR is eligible to receive additional sales milestone payments.
This is an impressive deal with $150 million upfront for European rights leaving ESPR with the much bigger U.S market. Additionally, the deal de-risks both BA and the BA/EZ combo as Daiichi would have conducted through due diligence on both efficacy and safety before paying $150 million. The clean safety signal may be most important as a few Wall Street analysts remain concerned about safety. ESPR remains on track for NDA submissions in Q1:19 followed by MAA submissions in Q2:19, with launch expected in the US and EU in H1:20.
Next up for ESPR in Q1 will be the topline results from Study 201, a Phase I trial testing the BA sustained-release formulation in overweight subjects. The Phase II BA/EZ combo pill trial in hypercholesterolemia patients with T2D (on stable diabetic regimen) will read out in 2H19. The company also plans to initiate a Phase III BA study in patients with high LDL-C and T2D in late 2019. Lastly, ESPR expects to fully enroll the CLEAR Outcomes study in 3Q19, with topline results on track to read out in 2022. ESPR’s management has delivered an excellent deal with Daiichi as they continue to execute and create shareholder value, a major global partner, significant upfront cash and funding, and no stock dilution. In our view, 2019 will see ESPR deliver more positive catalysts including marketing clearance from both the FDA and EU.