A tiny biotech's huge bet on a heart pill abandoned by Big Pharma just paid off. Esperion's CEO shares the old-school sales strategy he's planning for the drug.

• Esperion Therapeutics just got its first heart drug approved in the US, and the CEO told Business Insider the company is pricing the cholesterol-lowering medication at around $10 per day.
• "Our industry was built on once-a-day pills for chronic disease," Esperion CEO Tim Mayleben said in an interview.
• It's an old-school approach that supports blockbuster hopes for Esperion's pill.
• Other companies that have set higher prices for their heart drugs have fallen short in recent years.
• Visit Business Insider's homepage for more stories.

Esperion Therapeutics just received its first US approval on Friday, clearing the way to launch its first heart drug.

The approval wraps a long, strange journey for the Ann Arbor, Michigan-based biotech and its cholesterol-lowering pill, Nexletol. Esperion was acquired by pharma giant Pfizer in 2003 for $1.3 billion. A few years later, Pfizer ditched the business as part of a massive restructuring.

But Esperion's original founder and CEO, Roger Newton, wasn't done. He negotiated with Pfizer for about a year to sell back the Esperion name as well as an experimental heart drug that Pfizer had shelved. Esperion, version two, was launched in 2008, and that pill is now a US-approved heart therapy.

Even as cutting-edge therapies have arrived to treat or prevent heart disease, Esperion is betting an old-school approach will win out with this the Nexletol pill. The company plans to price it at around $10 per day before discounts and rebates. (Exact pricing details weren't immediately available.)

"Our industry was built on once-a-day pills for chronic disease," Tim Mayleben, who took over for Newton as Esperion's CEO in 2012, said in an interview.

Esperion isn't alone in avoiding a sky-high price for its heart treatment, at a time when parts of the industry are launching transformative drugs with six- and seven-figure price tags. Amarin has put forward a sales strategy based on selling lots of pills at a yearly list price of roughly $4,000 for its fish-oil-based pill, Vascepa.

That drug has vaulted the little-known New Jersey pharma company to a $6 billion market value, more than quadrupling its stock price since the critical late-stage trial succeeded.

Esperion's treatment, called bempedoic acid, has shown it can reduce cholesterol, in addition to what statins can provide patients. The company is also expecting an approval decision next week for a pill that combines bempedoic acid with a low dose of a statin.

"It's not groundbreaking by itself," said Dr. Peter Howard Jones, a heart clinical researcher at Baylor College of Medicine, who has helped run trials for bempedoic acid and for other heart-disease drugs.

Compare Nexletol and Vascepa to the fancier therapies, known as PCSK9 inhibitors. With a growing understanding of genetics in recent years, targeted therapies have been developed aiming to lower the risk of heart attacks and strokes.

Some high-priced heart drugs have been commercial disappointments

The first two of these therapies turned into surprise commercial flops, as health insurers pushed back against their prices. Both drugs are given as injections and have shown they can help patients by lowering the risk of heart attacks, strokes, and other events.

But the sales haven't matched the scientific excitement since launching in 2015. Despite significant promotion efforts, Amgen's Repatha netted $661 million in 2019 sales, while Sanofi and Regeneron's Praluent logged $287 million last year.

In late 2018, these leading pharmas recognized the disappointing sales, and in an unusual step slashed the list prices of Repatha and Praluent, from about $14,000 to $6,000 per year.

These contrasting approaches will only become more stark over the next few years. While Esperion and Amarin bank on the industry's history of successfully selling pills for chronic disease, new technologies like RNA interference are beginning to come of age and could soon yield new heart-disease treatments.

Novartis CEO Vas Narasimhan has likened its RNA interference drug to a potential vaccine for heart disease. The therapy, called inclisiran, targets the PCSK9 gene and is a twice-yearly injection.

The Swiss pharma giant acquired the drug this year through its nearly $10 billion acquisition of The Medicines Company.

A generational split?

Jones, the physician, said he's excited for some of these gene-based approaches, including the potential of Novartis' inclisiran going forward. He also said he thinks bempedoic acid will help some patients, particularly as he expects preferences to split by age.

Younger patients who aren't regularly taking pills may find the idea of a PCSK9 injectable more appealing, he said, while older patients already on medication can more easily add another pill to their medication regimen, he said.

In order to reach patients, both Amarin and Esperion are revving up their sales forces.

Amarin boosted its salesforce from 200 to 800 representatives in the past couple years. Esperion's Mayleben said the company will have a sales force of 300 in the field within four weeks, focused on a group of 36,000 doctors who write about 40% of all prescriptions for cholesterol-lowering drugs.

The huge patient population has helped stir investor interest in acquisitions. Biotechs about to make the leap to commercial markets are often seen by Wall Street analysts and investors are prime takeout targets, given big pharma's already-built commercial infrastructure.

Could Esperion be bought again? Esperion's CEO demurred on the potential for Pfizer, or another large drugmaker, to come calling.

"Our mindset is we are going to launch these drugs ourselves, but we are always open to collaborations or partnerships or more strategic relationships that would really bring maximum value to our shareholders," Mayleben said.

"We won't foreclose any discussion," he added. "We are open to any discussion."

• Read more:
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