Former CEO, Esperion Therapeutics
Esperion CEO on safety of new cholesterol drug
CNBC's Meg Tirrell reports on Esperion shares heading higher on its new cholesterol drug. Esperion CEO and President Tim Mayleben joins 'Power Lunch' to discuss the new drug and drug pricing.
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About Tim Mayleben
In October 2018, Tim Mayleben, then CEO of Esperion Therapeutics, discussed the company's experimental cholesterol drug bempedoic acid on CNBC. He stated that the drug is an oral, once-daily pill that demonstrated a reduction in LDL cholesterol by about 20% on top of statins and was safe and well tolerated. Mayleben said the drug is intended for patients taking the maximum tolerated dose of a statin who still need additional LDL lowering, including those who have had cardiac events. He noted that the drug did not appear to cause the same muscle aches associated with statins. Mayleben also said that in clinical studies involving roughly 4,000 patients, the drug's safety profile looked comparable to a placebo. He expected FDA approval and a market launch in 2020. Regarding business strategy, Mayleben said the company was open to a worldwide or regional partner for commercialization, as well as other strategic considerations, with the goal of benefiting shareholders. He added that his own wife, who has genetic cholesterol issues and cannot take statins, would be a candidate for the drug.
Transcript (12 segments)
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Reporter0:11
An experimental drug for cholesterol was shown this week to reduce levels of so-called bad cholesterol or LDL by 18 percent in a clinical trial compared with placebo, when given on top of common drugs called statins. A key question though is how this drug will compete with what's already on the market. Statins like Lipitor are now generic, they're very effective, and they cost just a few dollars a month. There's also a new set of drugs from Amgen as well as Regeneron and Sanofi that lower cholesterol levels even more, but they're given by injection and they're quite pricey. Joining us now to discuss all this is Esperion's Tim Mayleben. Tim, thanks so much for being here.
T
Tim Mayleben0:44
Thank you for having me.
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Reporter0:45
So tell us about these new data and where you see your drug fitting into that paradigm if it gets approved.
T
Tim Mayleben0:50
Sure. So the data that we announced earlier this week, as you said, we dropped cholesterol or bempedoic acid was safe and well tolerated as well. What we see this drug being used as is for the one in three people today who are taking a statin or the maximum dose of a statin that they can tolerate and not getting to their LDL cholesterol lowering goal. By putting bempedoic acid on top of those drugs, patients can get to goal. So again, one in three patients we think will be able to get to goal that are not getting to goal today. These patients typically have had cardiac events, so a heart attack or stroke. They're on maximum statin dosages and they still can't lower their bad cholesterol, so this helps them reach that last step.
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Reporter1:52
That's right. And I think the same muscle aches and pains that statins have been known for, and so we think that could be an important differentiator for our drug. Again, it's an oral, it's a once daily pill, so super convenient to take. And again, the results have been very good efficacy, 20% LDL cholesterol lowering, which we know can get six or seven million patients to their goal.
T
Tim Mayleben2:29
A key question for your drug is the safety, and that came up earlier in the year when you had a trial which looked like there may be some safety concerns about the drug. This one seemed to allay some of those fears, this new study, but JP Morgan came out with a note still pretty skeptical about the data. What can you tell us about the safety?
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Reporter2:54
You know, so what I would say first of all, looking at this data, just to remind, we have 4,000 patients that have enrolled and taken our drug, most for more than a year. When we've put all of that data together, and this is one of the announcements that we made earlier this week, when we put all of that data together, our drug looks as good as the sugar pill or the placebo that we had the patients not taking our drug taking. So very, very well received. FDA approval is expected, this could hit the market in 2020. So let's talk about pricing. Meg had alluded to this. You're expecting your price to be what, $3,500 list price? It's an oral, as you had mentioned, a pill. PCSK9, which is the new class of injectables, are priced at around $14,000 a year. So how do you determine what sorts of patients are for your treatment as opposed to PCSK9s?
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Tim Mayleben4:10
Yeah, so you know, I would start out by saying that from the beginning we have said, and again I would highlight that most of the folks in our team have been involved or were involved in the development of statins. So we have a history, a legacy in the development of LDL cholesterol lowering drugs, and we're developing a new drug now that can complement statins, but for the many, not for the few. So not the few patients that have super high levels of LDL cholesterol and need a specialty drug like the PCSK9s that you're talking about and have to inject themselves every couple of weeks. Our drugs are really positioned for the many patients who are on statins, who are not getting to their LDL goal, and need a convenient once daily pill that they can use and get their cholesterol down to their targeted goal.
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Reporter5:10
So when you look at your company's pipeline, you know you're really a pure play, this is what you're focused on. How are you looking at business development in terms of acquiring a partner outside the US to potentially help you sell the drug, or are you looking to build out your own internal pipeline, or both?
T
Tim Mayleben5:33
Yeah, sure. It is the key business question that I think we get from everybody. And our philosophy has always been we're going to put a structure in place from a commercial standpoint that will benefit our shareholders. So if that is a worldwide partner, it will be a worldwide partner. If it's a more regional partner, which is something we've talked about more recently, or if it's something else, we'll do what's best for our shareholders. But what I would say though is we have incredible conviction that what we're doing is valuable and it's going to benefit millions of patients who don't have good options available to them today. And I would just highlight that my own wife is someone who has genetic cholesterol issues. She was born with very high cholesterol levels and is also someone who can't take statins. So I've lived for a long time now with someone who experiences what a lot of patients across the US have experienced.
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Reporter6:46
Would she be taking this drug?
T
Tim Mayleben6:49
Would love to have her be taking this drug, absolutely.