After briefing investors this week on their strategy for tackling the blockbuster market for cholesterol lowering drugs, Esperion Therapeutics (NASDAQ: ESPR) shoot higher.
The company plans to make its cholesterol-lowering drug, bempedoic acid, a commercial success one day.
First a little background
Statins are widely used to lower bad cholesterol, and they are that most commonly prescribed drug on the planet. Ten million patients in the US alone take it every day, and at one point sales of the most widely used statin, Lipitor, exceeded $ 13 billion a year.
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While the body needs some cholesterol to function properly, too much bad cholesterol can clog arteries, causing heart attacks and strokes. In general, when bad cholesterol levels rise above 160, patients need to take steps to reduce their risk of cardiovascular disease. Unfortunately, more and more patients are finding that their bad cholesterol levels are too high, in part because their diets have switched to more fatty foods.
The guidelines require all people over the age of 20 to have their cholesterol checked at least every four years. However, the risk of high cholesterol increases with age, so many people are examined more often, especially if they have a family history of. have heart disease.
With a larger and longer living population and widespread screening, it probably isn’t shocking to learn that roughly one in five Americans between the ages of 40 and 75 are now taking statins to control their cholesterol levels. Despite widespread use, heart disease and stroke remain the leading cause of death in the United States, killing more than 600,000 people annually, according to the Centers for Disease Control and Prevention.
New ways to fight bad cholesterol
In 2015, Amgen Inc. (NASDAQ: AMGN) and Regeneron Pharma (NASDAQ: REGN) received FDA approval for two drugs that lower cholesterol completely new way. While statins reduce the body’s own cholesterol production by inhibiting the HMG-CoA reductase enzyme, Amgens Repatha and Regeneron Pharmaceuticals Praluent inhibit the PCSK9 gene to increase the number of bad cholesterol receptors in the liver. In studies, adding a PCSK9 inhibitor to statin therapy reduced bad cholesterol levels by an additional 60% in difficult-to-treat patients.
At Esperion Therapeutics, researchers are developing another way to lower cholesterol levels. Instead of attacking PCSK9, its Bempedo acid inhibits the activity of ATP citrate lyase, an enzyme that precedes the HMG-CoA reductase enzyme. So far, this approach seems to be effective too. In phase 2 studies, adding Bempedo acid to statin therapy lowered bad cholesterol by an additional 20%.
Plan for success
Amgen and Regeneron Pharmaceuticals found the hard way that efficacy alone does not guarantee commercial success in this indication. Although their PCSK9 drugs are highly potent, sales remain well south of the billion dollar blockbuster territory. In the first quarter, global sales for Repatha and Praluent were only $ 50 million and $ 36 million, respectively.
If Esperion Therapeutics hopes to do better, it has to approach the market differently than Amgen and Praluent. Fortunately, management seems to be doing just that.
One way Esperion Therapeutics is hoping to gain more significant market share is by combining Bempedo acid with Zetia, a widely used cholesterol-lowering drug that recently lost patent protection.
Esperion Therapeutics has developed a single-tablet combination of bempedoic acid and Zetia that can be taken with statins and is conducting a mid-stage study to see if this one-two punch is better than Zetia alone. If so, the eventual success of the Phase 3 trial could prompt doctors to switch from Zetia to the Esperion Therapeutics combination tablet. If so, that strategy could result in significant sales as Zetia and its sister drug Vytorin had annual sales of approximately $ 5 billion at their peak.
Another way Esperion Therapeutics wants to be successful in this indication is to price bempedo acid more competitively than PCSK9 inhibitors. PCSK9 inhibitors are complex biologics that are difficult to make, and Amgen and Regeneron charge about $ 14,000 a year for them. That price is shocking considering generic Lipitor can only cost $ 10 per month, according to GoodRx. Unsurprisingly, insurers have been reluctant to cover PCSK9 inhibitors, and that’s lower sales. To avoid this from happening to its drug, Esperion Therapeutics plans to target volume above price.
Data on deck
Investors should find out soon whether or not Esperion Therapeutics’ strategy of marrying bempedoic acid to Zetia is a good one. The Phase 2 study results for the combination tablet are fully registered and management says key data from this study will be available in the third quarter.
Undeniably, a win in this study improves Bempedo Acid’s chances of becoming a commercial success. However, investors should also know that it is a failure would not be a fatal blow to this company. Esperion Therapeutics has additional Phase 3 studies underway evaluating the use of bempedoic acid alongside statins without Zetia, and the results of these studies are expected in 2018. Assuming everything goes according to plan, the success of these studies will pave the way for FDA filing in 2019. and possible approval in 2020.
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