While Esperion’s investors have been through a roller coaster of reactions on whether or not the FDA was willing to accept LDL lowering as a suitable biomarker for an approval — ahead of an outcomes study — the CEO says that European regulators have consistently nodded their approval throughout the development process.
And that’s helped give Daiichi Sankyo confidence to offer $300 million in two payments to license EU and Swiss rights to their late-stage cholesterol drug bempedoic acid as Esperion $ESPR positions itself for a Q1 FDA submission followed up by a quick European pitch.
“The EMA never wavered,” Esperion CEO Tim Mayleben tells me in a preview to today’s announcement. “There was never any drama from the EMA on that point.”
Mayleben and the Esperion team will now get a $150 million upfront from the Japanese company, with another $150 million due on the first commercial sale of the drug in their new territory. Total milestones rack up to $900 million.
That gives Mayleben the cash to put together the commercial operations he wants in the US, with some more time to follow up on negotiations for Chinese and Japanese rights.
The deal comes shortly after Esperion touted data from its 52-week safety study, the last in a series of Phase III hurdles the biotech has had to clear as skeptics picked over its strategy and pooh-poohed its prospects. Analysts backing the company, though, have supported Esperion’s pitch that bempedoic acid can be priced under the PCSK9 drugs from Amgen and Regeneron/Sanofi, hitting a substantial market of people in need of significant, though not dramatic, lowering of LDL.
Daiichi, says Mayleben, has had years of experience marketing cardiology drugs, positioning them to play to a slate of single-payer systems that he believes will be receptive to their approach, angling to undercut PCSK9 on price. In Europe alone the commercial team amounts to about 1,000 staffers.
Whether the PCSK9 producers will sit still as Esperion and Daiichi carve away market share, though, has been a regular concern for critics of Esperion, who believe the big companies behind those drugs are in a position to crush bempedoic acid at any time. In the meantime, the PCSK9 players have been slashing their prices in an attempt to overcome a set of hurdles payers set up to prevent US members from accessing a therapy they see as far too expensive.
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