Lipitor is one of the most commonly prescribed medicines on the planet, and one of the men behind it, Roger Newton, is currently working on a cheap and effective cholesterol-lowering drug.
In this segment from Industry Focus: Healthcare, Motley Fool analyst Kristine Harjes and contributor Todd Campbell talk about what we know about the drug's production so far, what it could mean for patients and the company if it's approved, how this treatment would be different and more accessible than both statins and PCSK9 inhibitors, and more.
A full transcript follows the video.
This video was recorded on July 19, 2017.
Kristine Harjes: Let's move on to our last company of the day. This is Esperion Therapeutics (NASDAQ:ESPR), their ticker is ESPR. They have a $1 billion market cap, and it's already up 276% year to date.
Todd Campbell: Wow. These stocks have moved a lot, and that's because they're getting toward the finish line. All these companies are moving their drugs into phase 3, so we're not talking about phase 1 drugs. This is a very interesting stock to me, because it's run by a guy named Roger Newton. Roger Netwon, back in the olden days, he worked at Parke-Davis as one of the scientists who developed a drug that many people are aware of and many of our listeners may even be taking. It's called Lipitor.
Harjes: Yeah. Lipitor is the most commonly prescribed statin. It's off patent by now, but generic Lipitor is still very commonly used, and statins themselves are the most prescribed medicines on the planet.
Campbell: Tens of millions of patients take statins every year. I think over 40 million people in the U.S. are prescribed statins. Lipitor was a behemoth before losing patent expiration. That drug was hauling in about $13 billion a year in sales. It just goes to show you how big the market opportunity is in lowering bad cholesterol as a way to reduce the likelihood, hopefully, of major cardiac events, stroke, heart attack, and death.
Harjes: Right. Statins aren't perfect. We've talked a little bit on the show before about PCSK9 inhibitors, which are a different approach to lowering cholesterol levels. Now Esperion is looking at taking a different approach entirely. They're developing something called bempedoic acid to use alongside statins in order to reduce these levels of bad cholesterol. They had very positive phase 2 data, showed a 20% reduction in bad cholesterol levels when used alongside statins, and we should be getting phase 3 data out in the second quarter of 2018, which could potentially mean approval as early as the first half of 2019.
Campbell: What's interesting to me, too, about this story, Kristine, is not only that Newton successfully developed Lipitor, but he actually started a company also named Esperion Therapeutics in the late '90s to work on cholesterol-lowering medications.
Harjes: Yeah, this is Esperion part two.
Campbell: Yeah. So, we'll call this version 1.0, and the version he's doing right now is 2.0. Version 1.0, he sold that company to Pfizer for over $1 billion, $1.3 billion back in 2004. So, Newton and his team, they know a lot about lowering cholesterol. They have a lot of experience, decades of it, and two prior successes to their name. Bempedoic acid has a different mechanism of action than statins, it works upstream of statins. People think it might produce a better side-effect profile -- less impact on muscle weakness and some of the things that make many people intolerant of being able to take statins. Initially, the phase 3 trial that's being conducted now could clear the way for its use in people with high cholesterol levels caused by genetic mutations, so really tough-to-treat patients. Over time, however, their trial is ongoing and they could expand that population. Obviously, this drug may not be right for everybody, but you can draw and connect the dots that would make you think that if, eventually, approved, it could treat between 1 million and 10 million patients, depending on how the label reads over time. And if that's true, then yeah, you have a nine-figure drug, maybe a ten-figure drug, in the making. It won't be Lipitor-sized, but it can still be a very successful drug, and I think that more and more people are warming up to the concept that Newton might be able to succeed yet again in this indication.
Harjes: Absolutely. The size of the addressable population here will matter quite a bit, because pricing matters a lot when it comes to cholesterol medications. Because the statins are generic at this point, generic Lipitor is like $10 a month. It's super cheap. You look at newer drugs like PCSK9 inhibitors, they cost $14,000 a year. So, that's a very big range, and it seems like Esperion is planning to target volume over price. If you look at the way the pressure on the drug market is trending, that's probably a smart move, to try to get a little bit lower of cost, lower margins, but get them approved and out there to the widest number of people possible.
Campbell: Right, you could argue that the pricing of the PCSK9 inhibitors jumped the shark, they went too high, and as a result there was so much pushback and it's really crimped their use. I had an opportunity earlier this year to talk to management of Esperion, and have them walk me through what they thought the commercial opportunity could be for this drug, and what the pathway they would take to try to get this thing to market. I couldn't help but come away impressed. I think they have a very good strategy to file in 2019; data will come in 2018 from this first trial. They're also conducting a phase 3 trial that begins later this year that should have data at the end of next year that combines this drug, bempedoic acid, with Zetia. Zetia was another anti-cholesterol drug that, at its peak, was bringing in $4 billion a year in sales. So, a one-drug combination tablet that pairs up Zetia, which is still very widely used today, with bempedoic acid, could also be a needle-mover for this company. I like what's going on here. Again, you also have to throw that caveat in, that past performance does not guarantee future success. Anything can and does happen in phase 3 trials. But I kind of like the odds on this one.