For Daiichi Sankyo, recent results from the Phase III CLEAR trial of Esperion Therapeutics’ Nexletol (bempedoic acid) were not convincing enough to trigger a milestone payment.
Pictured: Daiichi Sankyo building/company courtesy
For Daiichi Sankyo, results from the Phase III CLEAR trial of Esperion Therapeutic’s cholesterol-lowering candidate Nexletol (bempedoic acid) were not convincing enough to trigger a milestone payment, Esperion announced in an SEC filing posted Wednesday.
Daiichi Sankyo bought exclusive European rights to bempedoic acid in a 2019 deal. Esperion’s shares dropped 55% in after-hours trading Wednesday following the filing’s release.
This payment dispute follows data from CLEAR released in early March which showed that Nexletol reduced the risk of challenging major adverse cardiovascular events (MACE), the study’s primary endpoint, by 13%. Esperion’s drug also reduced heart attack risk by 23% and coronary revascularization by 19%.
At the time, Sheldon Koenig, president and CEO at Esperion, called these results “practice changing,” exceeding the company’s expectations. Shareholders, however, were not as enthusiastic. Esperion’s shares dropped some 20% in reaction to CLEAR’s results.
Daiichi Sankyo was also not impressed.
In the SEC filing, Esperion insisted that it is entitled to receive $300 million in milestone payments once cardiovascular risk reduction data is included in Nexletol’s European label.
This milestone payment is “tied to the magnitude of the risk percentage reduction included in the label,” the SEC document read.
If Esperion can show that Nexletol can induce a relative risk reduction greater than 15% but lower than 20%, it will be entitled to $200 million. If it reaches or exceeds 20%, the payment jumps to $300 million.
Daiichi Sankyo disagreed with Esperion’s assessment and asserted that the agreement applies only to CLEAR’s primary endpoint. Since Nexletol could only suppress MACE risk by 13%, Esperion fell short of its milestone threshold.
For Esperion, however, this was an inaccurate interpretation of their 2019 agreement, “which refers only to cardiovascular risk reduction and not to any primary endpoint,” the company wrote in its SEC filing.
Esperion stated that Nexletol’s 23% risk reduction for heart attack makes it eligible for the milestone payment.
If the payment spat persists, Esperion is ready “to enforce its contractual rights and seek the milestone payments it believes it is entitled to,” the SEC document read.
Still, even if the company does claim its milestone, the payment dispute could delay the payment, which in turn “may significantly impact the company’s future capital needs.”
Nexletol is a non-statin medication that lowers cholesterol levels. It was approved in February 2020 for adults with atherosclerotic disease or heterozygous familial hypercholesterolemia.
The candidate has since struggled to establish a foothold in the market, forcing Esperion to shed 40% of its workforce in October 2021.
In 2022, Esperion posted a total revenue of $75.5 million, down 4% from the previous year’s earnings of $78.4 million.
