A new drug application (NDA) for Esperion Therapeutics Inc.'s (ESPR:NASDAQ) bempedoic acid as a hypercholesterolemia treatment was submitted to Japan's Pharmaceuticals and Medical Devices Agency by Esperion partner Otsuka Pharmaceuticals, reported H.C. Wainwright & Co. Analyst Dr. Joseph Pantginis in a Nov. 26 research note. Otsuka, a private firm, owns the exclusive rights to develop and commercialize this drug in Japan.
"We expect approval in H1/25, backed by favorable Phase 3 data," Pantginis wrote, referring to the CLEAR Outcomes clinical trial.
523% Return Potential
On the news, H.C. Wainwright maintained its $16 per share price target on Esperion, now trading at about $2.57 per share, noted Pantginis. The target implies a return on investment of 523%.
The Mich., U.S.-based biopharma remains a Buy.
Pursuing Additional Markets
The analyst highlighted that this current effort to get bempedoic acid approved in Japan is part of Esperion's multipronged expansion of the drug franchise into additional international markets.
Other regulatory approvals being sought are for Otsuka to market bempedoic acid under the name Nilemdo in Taiwan, for bempedoic acid as a new drug in Canada (response expected soon) and for possible partnerships on bempedoic acid in Australia and Israel.
"We are glad to learn that Esperion remains focused on a well-established commercial development strategy that validates a strong momentum for bempedoic acid," Pantginis added. "Esperion remains focused on strengthening bempedoic acid's future global growth by engaging with payers, physicians and healthcare professionals."
CLEAR Outcomes Trial Results
This Phase 3 trial, conducted in Japan, involved 96 patients with high LDL-C levels and either statin intolerance or inadequate response to statins, Pantginis explained. In the study, bempedoic acid met the primary endpoint of lowering cholesterol.
At week 12, in the bempedoic acid group, according to preliminary results, LDL-C was lowered 25.25% versus 3.46% in the placebo group, from baseline. Drug safety and tolerability were consistent with those in previous trials. No serious adverse events were seen.
Added Cardiovascular Benefits
Additional exploratory data from this same study, presented in the Scientific Sessions at the 2024 American Heart Association annual meeting, showed that bempedoic acid (Nexletol and Nexlizet) "builds upon its cardiovascular benefits," Pantginis reported. (Nexletol is bempedoic acid, and Nexlizet is bempedoic acid plus ezetimibe.)
Specifically, the drug reduced major adverse limb events in patients with pre-existing peripheral artery disease by 36% versus placebo. These results suggest that bempedoic acid could be considered for combination therapy, even with statins, in patients with peripheral artery disease.
Also in the study, bempedoic acid was shown to significantly lower the incidence of major adverse cardiovascular events in patients with liver steatosis or liver fibrosis. This suggests that such cardiovascular management should be started early in patients with metabolic dysfunction-associated steatotic liver disease.
"We believe these results add to the current LDL-C lowering and cardiovascular risk reduction labels and should be seen as valuable clinical outcomes that could potentially support the adoption of bempedoic acid by the physician community," wrote Pantginis.
Data Out of Germany
Pantginis also reported that long-term follow-up data from the MILOS trial in Germany "supports adoption of Nilemdo (bempedoic acid) and Nustendi (bempedoic acid plus) in Europe. These showed that after one to two years of treatment, LDL-C cholesterol in the overall population (451 patients) was lowered 30.3% on average.
After two years, the percentage of patients who met their LDL-C goals increased sevenfold to 35.3% from 4.9% at baseline. Similar trends were noted among high-risk patients, 32.5% versus 5.6%, and very high-risk patients, 35.2% versus 3.6%.
New Deal to Boost Revenue
In other news, according to Pantginis, Esperion entered into a new royalty purchase agreement with OMERS Life Sciences, a private company, in which OMERS will pay Esperion $304.7 million in cash for 100% interest in Esperion's royalty entitlement on Daiichi Sankyo Europe's net sales of Nilemdo and Nustendi in Europe.
Under this deal, Pantginis noted, sales of these drugs should generate long-term revenue for Esperion. So far, it has used these revenues to pay off its facility with Oberland Capital.
"This new deal allows Esperion to fully focus on the commercialization efforts for Nexletol and Nexlizet in the U.S.," Pantginis wrote.
Commercialization of these two drugs is in progress in the States. Coverage of them by commercial insurers and Medicare increased to greater than 92% and greater than 65%, respectively. This suggests physician confidence in Nexletol and Nexlizet and predicts strong sales in the near term and beyond.
"Updated utilization management criteria for more than 165 million lives aligned to the new labels across commercial, Medicare and Medicaid payers," wrote Pantginis.
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