SAN FRANCISCO—With approvals looming for two cholesterol-busting drugs, Esperion is getting ready to rumble. It’s building a team of 300 sales reps to make sure doctors know to prescribe the new drugs to patients who struggle to control their cholesterol. And it plans to sell the drugs at a price that ensures patients prescribed them can actually afford them.
When asked how the biotech landed on that price for bempedoic acid and its pill combining bempedoic acid with ezetimibe, a cholesterol-busting drug often prescribed with statins, Chief Commercial Officer Mark Glickman said Esperion worked with managed care organizations to determine a price in an affordable tier.
“Getting the best formulary position was the goal, to make it affordable to the healthcare system and the patient,” Glickman said at the J.P. Morgan Healthcare Conference. “Believe it or not, we still do OK too. It doesn’t have to be win-lose.”
We don’t know the price yet, but if Esperion keeps its promise, it’ll be a far cry from the trend of ever-rising prices in the biopharma industry—a pattern that longtime biotech investor Alexis Borisy just started a new company to combat.
“The biggest mistake that pharma companies made over the last several years as they asked managed care what would be a good price … and then ignored them,” Glickman said. “I promise you, nobody told Sanofi and Regeneron that $14,000 was a good price for a PCSK9.”
Esperion expects the FDA to rule on its drugs in February. It has also filed the duo for approval in Europe. Its pivotal program included four studies for bempedoic acid and one study of the combo pill in patients who have atherosclerosis—plaque buildup in their arteries—or who are at risk of developing the condition. By JPM 2021, Glickman is confident Esperion will be the “little company that could.”
“We will be looking back at the story of how many patients we helped this last year,” he said. “It will be a story about what we’ve done well: made sure physicians are educated about this wonderful medicine, but the dire state of getting LDL cholesterol to goal.”
Despite the success of multiple statins—a class of drugs that Esperion CEO Tim Mayleben thinks has no comparator in any other disease area—between 10% and 20% of people who take them still struggle to lower their cholesterol to a level deemed healthy.
“Think about the 40 million people taking a statin today. That's probably 9 million or 10 million people who can’t get their bad cholesterol to a healthy level on statins alone,” Mayleben said. Some of those people can’t take statins at all because they suffer side effects, while others can’t take enough of a statin to reduce their cholesterol to a healthy level.
If one statin doesn’t quite make a dent in a person’s cholesterol, their doctor can’t just add a second statin to their treatment.
“That would be toxic, so people need a nonstatin means of lowering bad cholesterol. That’s where our drug comes in,” Mayleben said.
If approved, Esperion reckons bempedoic acid will be the first once-daily, non-statin pill to lower LDL, or “bad,” cholesterol in about 20 years.
Several big names in pharma have tried to bring a non-statin drug to market: Pfizer, Roche, Eli Lilly and Merck poured money into a class of drugs called CETP inhibitors that turned out to be a bust. That string of failures may have turned off would-be cholesterol busters.
“The drug class was not successful. Bit companies spent lots of money on this and were unsuccessful. I think it’s a little bit like the Alzheimer’s area today; after a number of failures, people start to give up and say, ‘let’s not keep putting good money after bad until we figure something out,” Mayleben said.