Study Reveals PCSK9 Drugs Can Save Heart Disease Patients

By Motley Fool Staff Markets Fool.com

Conquering cholesterol is one of the biggest challenges facing cardiovascular disease patients, and a new study conducted by Amgen Inc. (NASDAQ: AMGN) shows that its cholesterol-busting drug Repatha may reduce the risk of heart attack and stroke. Will this study propel Repatha to billion-dollar blockbuster drug status?

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In this clip from The Motley Fool's Industry Focus: Healthcare podcast, healthcare gurus Kristine Harjes and Todd Campbell discuss how PCSK9 inhibiting drugs like Repatha can reshape patient treatment for cardiovascular disease and drive Amgen's revenue higher.

A full transcript follows the video.

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This podcast was recorded on Feb. 15, 2017.

Kristine Harjes: Yesterday was Valentine's Day, Feb. 14. And we're not done celebrating just yet. In the spirit of the holiday, this week's show is all about hearts. Specifically, we're going to give some cardiac stocks a little bit of love. It's a pretty big deal. When you look at the heart disease, it's the number one cause of death in the United States. It kills more people than cancer and anything else. It's just insane when you look at some of the numbers. Somebody in the U.S. has a heart attack every 34 seconds. So, clearly, in the world of healthcare and drug developers and medical-device makers, this is a big market. So, there are a lot of stocks that we can talk about, and a lot of different devices and drugs. We're going to try to touch on a whole bunch of different ones today. Sound good, Todd?

Todd Campbell: This is going to be an exciting show. I'm really looking forward to this.

Harjes: Yeah. So, let's start with cholesterol. Twenty-five million, and probably more, Americans take statins to control their cholesterol to prevent cardiovascular diseases. But, there is a new type of cholesterol buster that has come into town -- actually, it's already in town, it's already on the market. These are called PCSK9 inhibitors. I think I've talked about them on the show before, but as a refresher, Todd, do you want to explain what makes them different?

Campbell: Sure. We have the major ways to treat high bad cholesterol. We have statins, that have been around since the '90s. What statins do is limit the production of cholesterol in the liver. Now, we have this other way of attacking or lowering cholesterol called PCSK9 inhibitors because they block an enzyme in the liver that's responsible for breaking down these receptors that are in the liver that help clear bad cholesterol from the bloodstream. Or, saying this a little bit more simply, because it blocks this, there are more receptors in the liver, so more bad cholesterol can be cleared from a patient's blood stream.

Harjes: Yeah. It feels like a triple negative going on there, but the things that you need to know is that basically, they work differently from statins which is great, because statins don't always work to the fullest extent, and sometimes they're even poorly tolerated by patients.

Campbell: Yeah. As you mentioned, probably 25 million or more people taking statins to help lower or control their cholesterol. Many of these patients are not adequately treated by statins. As a result, those figures you were talking about earlier, there is a connection between cholesterol and cardiovascular events. At least, we're discovering that as we do more and more research into heart disease and stroke. So, anything that we can develop and get on the market and get to patients that lowers cholesterol is a good thing. These drugs, when they came out, Amgen makes one, it's called Repatha, it came out and got approved in August of 2015. Repatha is fast becoming an important drug. The sales are not blitzkrieg sales yet, certainly not treating as many patients as statins are, but there are reasons to think that the use of these drugs is going to climb over time.

Harjes: Right. And a big one of those reasons is that, pretty recently, we found out that Repatha actually reduces cardiovascular risks more than just taking statins alone. This was a huge deal when these numbers came out, because A, they were long-awaited, and B, they're really important to insurers. As of right now, insurers are a little bit dodgy about whether or not they want to cover the cost of this drug. It's expensive, it's $14,000 a year, whereas statins cost hundreds of dollars. There's a tremendous difference in price tag. But, with evidence that Repatha can reduce these risks, many think that insurers will start covering this drug now.

Campbell: Yeah, that was one of the main reasons, right, Kristine, that sales of this drug haven't hit blockbuster levels yet.

Harjes: Which they were largely expected to be.

Campbell: Oh, big time. If you just do the simple math, if you have 25 million people on statins, if even only a fraction of those patients start using a drug that cost $14,000 a year, you're talking about billions of dollars in sales. So, the opportunity is very big, because, now, this study has come out and shown that there is indeed a link to taking this with statins and the ability to reduce cardiovascular events like heart attack and stroke. It's a pretty important finding. There are two drugs on the market right now that are PCSK9s. There's Amgen's Repatha, and there's also another drug called Praluent that's made by Sanofiand Regeneron. But, what investors need to know about that is that Amgen is suing those companies for patent infringement, and so far they are winning.

Harjes: Right. So, Praluent could, essentially, be forced off the market as soon as next month. This is going back and forth and back and forth in courts, but as of right now, it does look like Amgen has the upper hand.

Campbell: Yeah. There's an appeals court decision that will come out they say some time as early as June or as late as December. If Amgen comes out victorious, then Sanofi and Regeneron are either going to have to pull their drug or figure out a deal with Amgen to pay them a royalty stream. Now, I don't know why Amgen would want royalties if they have a drug that already delivers the goods in cardiovascular outcomes. Maybe it'll come down to -- Sanofi and Regeneron are conducting their own study in cardiovascular outcomes -- who had the better outcome in those studies.

Harjes: Right. What's interesting is that we actually don't know the magnitude of the outcome from the Repatha study. We don't have the numbers on that yet.

Campbell: No, and we won't get those until a key industry conference in March. Maybe investors will tune into our show as we get further into spring, and we'll give people an update on what those numbers actually were. We know there was a statistical benefit, we don't know how big that statistical benefit is. And the number, in case you're curious, that people are targeting as being a good number, would be greater than a 20% reduction in those events. If you see that, then it's likely to open up many more patients to qualify for these drugs.

Harjes: Right. And speaking of timelines, the Praluent data, for their long-term cardiovascular risks trial, that study will come out later this year. That's even farther down the road.

Campbell: Right. And what's really interesting is, will that data come out before the appeals court issues their decision or after? That's really going to make things complex for these companies, to figure out how to handle this situation depending on who wins.

Harjes: Yeah. I think that whether or not Amgen decides to go for a royalty largely depends on the outcome of these trials.

Kristine Harjes has no position in any stocks mentioned. Todd Campbell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.