Hearts & Minds Blog
Reflecting on a Focused 2017 and Looking Ahead to a Transformational 2018December 28, 2017
The past year was marked by tremendous progress for our bempedoic acid-based franchise – perhaps most importantly the achievement of positive regulatory interactions in the U.S. together with continued over-achievement on clinical trial execution – and your support was critical to this success. As I look back on these accomplishments, I’m struck by the focus, determination, perseverance, and “grit” our team demonstrated by:
- Securing regulatory confirmation for the pathways to approval for an LDL-cholesterol lowering indication for both bempedoic acid and the bempedoic acid / ezetimibe combination pill, as well as the future cardiovascular disease risk-reduction indication in March and June;
- Completing enrollment of over 3,600 patients in the global pivotal Phase 3 program for bempedoic acid in September;
- Initiating the pivotal Phase 3 study for the bempedoic acid / ezetimibe combination pill in November;
- Advancing the CLEAR Outcomes cardiovascular outcomes trial (CVOT), incorporating key learnings from recent CVOTs in the space;
- Reporting the genetic validation of ATP-Citrate Lyase (ACL) inhibition through Mendelian randomization studies in March which demonstrated bempedoic acid should reduce the risk of cardiovascular events by the same magnitude as statins, ezetimibe and PCSK9 inhibitors;
- Continuing to build the financial resources to rapidly advance our programs by raising $175 million in cash;
- Hosting presentations from world-renowned industry experts at our Investor Day in October who provided important context and support for our convenient, complementary, cost-effective oral, once-daily LDL-C lowering therapies.
We remain singularly focused on evolving what was, almost 10 years ago, a very promising oral small molecule, discovered at the “first Esperion”, into a convenient, complementary, once-daily, oral, LDL-cholesterol lowering therapy – both as monotherapy, and in combination with ezetimibe to help the millions of patients that can’t or won’t take statins or who need accessible LDL-C lowering therapies to reach their LDL-C lowering goals. Reporting results from five pivotal Phase 3 studies, we expect 2018 to be the most transformational and defining year in our company’s history, culminating in tandem NDA submissions for both bempedoic acid and the bempedoic acid / ezetimibe combination pill by the first quarter of 2019.
As we look across our therapeutic landscape, we expect the results from ODYSSEY Outcomes early next year will further validate LDL-cholesterol lowering as a reliable surrogate for cardiovascular disease risk reduction. By early 2019, we anticipate new guidelines from ACC/AHA will recommend even lower target levels of LDL-cholesterol for patients. With over 10 million patients not reaching the current LDL-cholesterol-lowering goals despite the use of standard of care treatments there is even greater urgency for patients to gain access to convenient, complementary, cost-effective, oral LDL-cholesterol lowering therapies. By early 2020, we hope that bempedoic acid and the bempedoic acid / ezetimibe combination pill will be there for patients and their physicians.
At this time of year it is always important to pause and reflect on our blessings. I want to again express our gratitude for your continued support and efforts. I expect the future – both near-term and longer-term – to be the most rewarding in our history. I look forward to sharing it with you.
Happy Holidays – and we look forward to a very rewarding and prosperous new year!