“This may be the biggest development in cardiovascular prevention since statins.”
That’s a quote from Dr. Deepak Bhatt, professor of medicine at Harvard Medical School and one of the world’s leading experts on heart disease.
He’s referring to a development that could be a game-changer for cardiovascular medicine.
To give you an idea just how big this development is, consider that the statin drugs Dr. Bhatt mentioned have generated hundreds of billions of dollars in sales since they came on the scene in the late 1980s.
The statin drug Lipitor alone has racked up more than $150 billion in lifetime sales, making it the best-selling prescription drug of all time.
In 2006, the peak year for Lipitor, the drug generated $12.9 billion in sales, which made up 26.7% of pharma giant Pfizer’s revenue that year.
That would have put Lipitor in the top third of the Fortune 500 in terms of revenue if it were a standalone company.
If Lipitor had been a public company back in 2006, my calculations show it would have been valued around $50 billion. That’s bigger than Twitter and Delta Air Lines are today.
Statins like Lipitor have become some of the most commonly prescribed drugs in the world because they reduce the risk of heart attack and stroke.
But one company has now developed a different kind of drug to reduce the risk of heart attack and stroke. This drug could eventually treat tens of millions of people and help save countless lives… sending the company’s stock to the moon in the process.
But you don’t have to wait for “eventually” for big gain potential.
Certain catalysts could propel the stock significantly higher within the next six months. So this is an opportunity to take advantage of now.
The #1 Disease That Kills Americans
Most people assume cancer kills more Americans than any other disease. After all, there are more than 100 types of cancer. And it’s likely affected everyone’s life in one way or another.
But cardiovascular disease (CVD) is actually the #1 killer in the United States.
According to the American Heart Association (AHA), CVD caused 840,678 American deaths in 2016. That’s almost 38% more than from all cancers combined.
Like the term cancer, CVD refers to a number of different conditions. As defined by the World Health Organization, it is a group of disorders of the heart and blood vessels, which includes heart attacks and strokes.
A big CVD risk factor is too much LDL (“bad”) cholesterol (LDL-C) in your blood. So doctors are highly focused on lowering LDL-C levels in their patients.
The National Heart, Lung, and Blood Institute (NHLBI) says your LDL cholesterol should be less than 100 milligrams per deciliter (mg/dL).
And now there’s a big trend to get that number even lower. My colleague, Dr. Mike Roizen, says the new number is 70 because that’s where you really see a big reduction in heart attack risk.
Meanwhile, the Centers for Disease Control (CDC) estimates that a whopping 78 million American adults have high LDL cholesterol.
Since the late 1980s, doctors and patients have relied on statins like Lipitor to lower “bad” cholesterol levels in addition to diet and exercise.
But while controlling LDL cholesterol is vitally important to reducing cardiovascular risk, it’s not enough.
Studies have shown that about 65–75% of patients with well-controlled LDL-C are still at risk for heart attack and stroke because of elevated triglyceride levels.
Why Triglycerides Matter So Much
Triglycerides are a type of fat found in your blood.
When you eat, your body converts calories you don’t immediately need for energy into triglycerides and stores them in your fat cells. Hormones then release triglycerides for energy between meals.
So triglycerides are important to our health. But elevated levels put us at risk.
The American Heart Association (AHA) says that high triglycerides are associated with increased cardiovascular events, medical costs, and resource use.
According to the AHA, normal triglyceride levels are less than 150 mg/dL. Borderline high is 150–199 mg/dL. High is 200–499 mg/dL. And very high is 500 mg/dL and up.
Diet and exercise can help lower triglyceride levels, but that’s not enough for many patients.
About 50 million adults in the US have elevated triglyceride levels (150 mg/dL and up). And there’s currently no FDA-approved therapy for lowering cardiovascular risk beyond drugs designed to lower LDL cholesterol.
But this company is bound to change that...
25% Less Heart Attack Risk
Our Healthy Returns portfolio company, Dublin, Ireland-based Amarin (AMRN) has developed a drug called Vascepa to reduce heart attack and stroke risk in patients with elevated triglyceride levels.
Vascepa is already FDA approved to treat the 4 million US patients with very high triglycerides (500 mg/dL and up).
But the company recently announced results of a near-decade-long clinical trial called REDUCE-IT that could expand Vascepa’s addressable market by more than 10 times.
REDUCE-IT was a global study of 8,179 statin-treated adults with elevated cardiovascular risk despite well-controlled LDL cholesterol. Amarin announced results of the trial in September and November of 2018… and these results were extraordinary.
Vascepa lowered the risk of major cardiovascular events in these patients by 25%. It also reduced heart attack and stroke risk by 31% and 28%, respectively. And that was “relative risk reduction” on top of statin therapy, which means that the drug added significantly to the cardiovascular risk-reducing effects of statins.
Amarin took these extremely successful trial results and submitted a Supplemental New Drug Application (sNDA) to the FDA at the end of March 2019 seeking an expanded label for Vascepa.
The expanded label would allow Amarin to market Vascepa to patients with borderline to high levels of triglycerides (between 150 and 500 mg/dL) in addition to the “very high” group.
The FDA has scheduled an advisory committee meeting in mid-November to discuss the decision. Advisory committees provide the agency with independent advice from outside experts, and it often follows the advice of the committee (but not always).
The FDA will likely make a decision on Vascepa’s label expansion by late December of 2019 or early January of 2020.
Both the advisory committee meeting and FDA decision are big potential catalysts for Amarin’s stock. And I expect a positive outcome from each of these events.
In addition to the incredible data from the REDUCE-IT trial, the Institute for Clinical and Economic Review (ICER) recently released a report concluding that Vascepa provides a clinical benefit, reduces cardiovascular risk, and is cost effective. This should lead to more payers (insurance companies and government) covering the drug.
Recently, the American Diabetes Association recommended Vascepa as part of the new standard of care for diabetics who are currently on a statin and have elevated triglyceride levels, which should help accelerate growth in the quarters ahead.
Amarin is still a great Buy at current prices.
(The above is an excerpt from a recent Healthy Returns issue. For more information, including detailed buy instructions, stop-loss and target price, try Healthy Returns for a month. You’ll get full access to our portfolio, stock updates, archives, and this month’s new stock recommendation. It’s only $9.95 and you can cancel at any time—so why not give it a try?)
Editor, A Rich Life
Please note that the companies Chris mentions in A Rich Life are just meant to give you some ideas for your own research... not official investment recommendations. There’s no A Rich Life portfolio, and Chris doesn’t keep track of these companies.
Chris does provide actual stock picks—thoroughly researched and vetted, with entry and target prices, full company analysis, the whole nine yards—in his investment newsletter, Healthy Returns. Click here to subscribe to Healthy Returns at a low monthly rate.