- Esperion Therapeutics licensed out commercial rights in the European Economic Area and Switzerland for its experimental cholesterol-lowering therapy in a potentially $900 million deal with Daiichi Sankyo Europe, a wholly-owned affiliate of the Japanese pharma.
- The Ann Arbor, Michigan-based lipid management company plans to file drug applications for bempedoic acid in the first quarter of 2019 for the U.S. and in the second quarter with the European Medicines Agency. Company executives said they expect approval decisions in the first half of 2020.
- Esperion will get $150 million upfront and $150 million more upon first commercial sales in the territory. The pharma will also earn royalties between 15% and 25% along with potential sales- and regulatory-based milestone payments totaling up to an additional $600 million, an Esperion spokesperson said.
Esperion rolled out results from a fifth Phase 3 study in October that helped steady bempedoic acid's prospects for approval in the eyes of many experts. Data released last May had raised safety questions for some, showing a disparity in patient deaths between the placebo and treatment arms. Thirteen people died on Esperion's drug while two died on placebo in a study of more than 2,200 patients.
With additional data and time, Ethan Weiss, a cardiologist and associate professor at the University of California, San Francisco, called those safety concerns from May a sideshow. Instead, Weiss is focused on bempedoic acid's results in a long-term cardiovascular outcomes study.
"I think it's a really interesting drug, but we have no idea how it's going to perform," Weiss said in an interview Friday with BioPharma Dive. "We've had that lesson again and again."
Esperion expects to readout results from such a trial in 2022. That study is still recruiting, but is expected to enroll 12,600 participants and have an average treatment duration of 3.75 years.
Until then, Weiss said he can see the Food and Drug Administration approving the drug, as its completed studies have shown it is at least safe enough for a small subset of patients.
However, commercialization will be a different story for Esperion, which hopes to find a niche in a cholesterol-lowering market dominated by generic statins and generic Zetia (ezetimibe).
Esperion is looking to treat patients who haven't sufficiently achieved LDL-cholesterol lowering on statins as well as those who don't respond to statins.
The rise of PCSK9 inhibitors from Amgen and Regeneron — with recently slashed list prices — will provide more potential competition. Those are injectable while bempedoic acid is in pill form.
Finally, Amarin's fish oil drug, Vascepa (icosapent ethyl), is also poised to play a factor in the cardiovascular market following a recent cardiovascular outcomes study that found a 25% relative risk reduction in the first occurrence of major adverse cardiovascular events.
"It's a more crowded space," Weiss said. "We are just dealing with more and more options, which is great for patients, but it's going to be complicated for these companies."
The cardiologist said he sees Vascepa as a bellwether for the industry, and specifically for Esperion's drug. Weiss expects slow commercial uptake for Amarin's treatment due to its newness and unanswered questions on how the therapy works.
Esperion's deal with Daiichi Sankyo Europe also gives the latter company the exclusive commercial license for those European areas for a combination pill of bempedoic acid and ezetimibe.
Esperion's share price dropped roughly 6% in the first few hours of market trading.