Cardiovascular disease remains the world’s number one killer and one of the largest pharmaceutical markets, explains biotech expert John McCamant, editor of The Medical Technology Stock Letter.
Despite this huge need and opportunity, the competitive landscape in cardiovascular drug development is minimal; the primary reason is the success of statin’s over the last 30 years and their ability to lower LDL.
However, there is a subgroup of about 10% patients who cannot tolerate statins due to the side effect of muscular skeletal pain (“statin intolerant” patients) — not an insignificant 3.5 million people.
The lead drug development candidate from Esperion (ESPR) is bempedoic acid (BA) – an innovative, complimentary, non-statin LDL cholesterol lowering therapy.
Esperion's drug candidate has significant potential including its convenient, once-a-day oral dosing, an excellent safety profile and a significantly lowers LDL by about 30%. In multiple clinical trials, the drug has been shown to be safe and well-tolerated with no serious or unexpected adverse events.
The company’s second product is BA+EZ, an innovative, complementary, non-statin LDL-C lowering therapy combining bempedoic acid and Zetia (ZE). Like BA, ZE offers a convenient, one-pill-a-day dosing. The BA+EZ combo has the potential to deliver up to a 50% LDL-C lowering.
A pivotal trial is expected to enroll about 12,,600 station-intolerant patients with history of or at high-risk for cardiovascular disease. Esperion remains on track for filing an NDA in the first half of 2019.
The current corporation is the second iteration of Esperion. The original Esperion, which focused on developing therapies to regulate HDL-C levels, and was purchased by Pfizer (PFE) in 2004 for $1.3 billion.
The current Esperion was founded in 2008 by former executives and investors of the original Esperion. The original Esperion was a very successful recommendation in our portfolio and in our view, the second Esperion will also be a success.
Both ESPR’s were led by current CEO Tim Mayleben and also featured the inventor of both Lipitor and BE, Roger Newton – on their Board. The rest of the management team also has significant cardio drug
development expertise.
In our view, ESPR is well positioned to bring an extremely scarce cardio drug asset all the way to
commercialization. With the true scarcity value rising for novel cardiovascular lowering drugs, Esperion is, in our view, "The New Kid In Town" in cholesterol treatment.
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