When two companies partner up to develop or market a drug, milestone payments are often involved. But when trial results aren't exactly clear-cut, those deals can turn sour.
Take the situation with Esperion and Daiichi Sankyo. Back in 2019, Esperion licensed European rights to its lead drug, bempedoic acid, to Daiichi in exchange for $300 million upfront and up to $900 million in milestones. The companies expanded their collab to other geographies two years later.
In the meantime, the drug in February 2020 won an FDA approval alongside diet and maximally tolerated statin therapy to help lower cholesterol in certain patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. It's marketed in the U.S. under the brand name Nexletol.
In Europe, authorities endorsed the drug in April 2020 under the brand name Nilemdo.
Much of the partners' marketing efforts revolve around a push to gain a label expansion showing the drug can help lower cardiovascular risks. There, the partnership seems to be devolving into a public fight.
Earlier this month, Esperion touted data from the CLEAR Outcomes trial. In the study of 14,000 patients, the drug reduced the risk of heart attack and coronary revascularization by 23% and 19%, respectively, compared with placebo, Esperion said at the time.
In addition, the drug delivered a 13% improvement versus placebo on a composite cardiovascular endpoint called MACE-4. That endpoint looked at a range of outcomes including cardiovascular death, heart attack and stroke.
With the findings in hand, Espersion said it was on track to submit regulatory filings to authorities in Europe and the U.S. in the first half of 2023. But in a new Securities and Exchange and Commission filing, Esperion revealed that Daiichi Sankyo doesn't agree that the data are strong enough to support milestone payments.
Esperion says it should be entitled to around $300 million in milestone payments tied to a potential label expansion in Europe.
If necessary, Esperion said it will “enforce its contractual rights and seek the milestone payments it believes it is entitled to." But even if it can secure the funds, the payout might be delayed as a result of the dispute. That may “significantly impact” Esperion’s future financial position.
Esperion is hungry for the cash. It reported full-year revenues of $75.5 million, down 4% from 2021’s $78.4 million. In 2021, the company cut 40% of its workforce to save on expenses, admitting it faced challenges with its pandemic-era launch.