Esperion strikes Japan deal for 'goldilocks' cholesterol drug, bags $60M cash as pandemic forces virtual US rollout
Esperion has forged its first regional deal for Nexletol and Nexlizet since winning US and EU approvals for the cholesterol fighting drugs, bagging $60 million upfront while securing a pharma partner in Japan.
Not only is Otsuka promising $450 million in total milestones and 15% to 30% royalties, it’s also picking up the tab for all development, regulatory and sales in Japan — which Esperion estimates would amount to $100 million over the next few years.
“We had originally set ourselves a goal to get something done by the end of last year,” Esperion CEO Tim Mayleben told Endpoints News. “Then as the approvals were coming into focus and we knew from our discussions with regulators that those were likely to happen in the first part of this year, we were hearing from potential partners at the same time that our negotiations would improve once we had the approvals in hand. So we again made the explicit decision to push this out a few months and so that definitely paid off.”
By their count, there’s never been a Japan deal with that big of an upfront. Their new Japanese partner also brings established relationships with healthcare providers to its long history of commercializing cardiovascular medicines.
By hitting the goldilocks zone between old statins and expensive anti-PCSK9 therapies — with all the properties that resemble “the old comfortable shoe” as chief commercial officer Mark Glickman describes it — Esperion promised to serve hypercholesterolemia patients who are either intolerant to statins or need further cholesterol reduction, but are priced out of the new generation of treatments.
Their main product, bempedoic acid, is a prodrug that inhibits adenosine triphosphate citrate lyase (ACL) in the liver. Since that enzyme plays a role in cholesterol synthesis within the cell, blocking it results in less intracellular cholesterol and more LDL receptors to capture cholesterol in the blood.
Nexletol is a tablet consisting just of bempedoic acid. With Nexlizet, they add in the cholesterol absorption inhibitor ezetimibe to boost the potency.
An oral, once-daily non-statin therapy would be a welcome addition to any company with a cardiovascular focus, Mayleben said, hinting that they are in the final stages of closing a “true rest of world” deal, including China, with a multinational pharma company. That would give Esperion three partners, a number that he believes is manageable for his biotech.
“Those travel extraordinarily well across different geographies,” he said. “Some of these new fancier technologies don’t travel as well — monoclonals and what not, because there’s an even greater aversion to injectable therapies or just because of the cost.”
Daiichi Sankyo signed up for Europe and Switzerland rights back in January 2019, a year before the EMA gave the greenlight, with $150 million upfront in a deal worth $900 million. The European Commission cemented that with a final OK under the brand names Nilemdo and Nustendi. The first sale would yield another $150 million in milestones.
Meanwhile in the US, Esperion has already launched Nexletol to a pandemic-stricken country, setting up a remote campaign to encourage adoption of its $10 per day regimen. The Nexlizet rollout is scheduled for July.
“In response to the spread of SARS-CoV-2 and COVID-19, our commercial and medical organizations have suspended personal interactions with physicians and customers and will be conducting activities virtually,” it wrote in a recent SEC filing.
Having completed two and a half weeks of intensive training in both the new digital tools and virtual ways of marketing, the field team has just begun making calls last Thursday — with extra sensitivity to local situations.
“None of our sales representatives are calling anybody in the New York area,” Mayleben said. But places like Florida, where he is based, offer a little more room to begin pushing a new drug. “We’ll start to see the results of that in our script data perhaps by the end of the month.”