HLS Therapeutics and Esperion partner to market NEXLETOL® and NEXLIZET® in Canada

HLS Therapeutics Inc., a pharmaceutical firm dedicated to addressing unmet needs in psychiatric and cardiovascular treatments, has announced a partnership with Esperion Therapeutics Inc. This collaboration aims to in-license and introduce two significant medications, NEXLETOL and NEXLIZET, into the Canadian market. These drugs, targeting cardiovascular conditions, are already sanctioned and available in the United States and various European nations. They are currently under regulatory review in Canada, with a decision anticipated by the end of 2025.

The partnership builds on Esperion's submission of New Drug Submissions to Health Canada in late 2024. Under the terms of the agreement, HLS will spearhead the process of obtaining Canadian approval for both medications. These oral drugs were initially approved by the U.S. Food and Drug Administration in 2020 to assist in lowering low-density lipoprotein cholesterol (LDL-C) levels. In 2024, their usage was broadened to encompass cardiovascular risk mitigation for patients who cannot tolerate statin therapy, bolstered by findings from the CLEAR Outcomes trial.

The introduction of NEXLETOL and NEXLIZET could potentially benefit more than 500,000 Canadians. This number includes individuals with high LDL-C levels who are unable to achieve their LDL-C targets despite existing treatments or who cannot use statins due to intolerance. HLS's CEO, Craig Millian, expressed enthusiasm about the collaboration, emphasizing how these innovative treatments align with HLS's strategy and fortify its presence in the Canadian cardiovascular sector.

Esperion's President and CEO, Sheldon Koenig, echoed similar sentiments, appreciating the opportunity to work with HLS to provide advanced therapeutic options for Canadian patients. He highlighted HLS's strong reputation in Canada, noting its robust capabilities and strategic relationships in the cardiovascular therapeutic domain. This partnership is seen as an extension of Esperion's global commitment to tackling cardiovascular and cardiometabolic diseases.

Financially, the agreement entails an initial payment of $1 million to Esperion, with an additional $1 million contingent on the approval from Health Canada. Furthermore, the deal includes customary royalties on subsequent sales and potential milestone payments connected to pricing, reimbursement, and achieving substantial commercial sales benchmarks. HLS plans to finance all upfront and milestone-related payments through its existing cash reserves, which means it won't require additional funding. The company also plans to utilize its current commercial infrastructure, thus not expecting a significant rise in operational expenses.

HLS Therapeutics, established in 2015, is renowned for the acquisition and commercialization of late-stage development and branded pharmaceutical products across North America. The company's focus is on products that meet unmet needs, particularly in psychiatric and cardiovascular treatment areas. HLS boasts a seasoned management team with a track record of success in these fields.

On the other hand, Esperion Therapeutics is recognized for its commercial-stage endeavors focused on the introduction of new medications, particularly for patients battling cardiovascular diseases and high LDL-C levels. Esperion's medications are supported by the CLEAR Cardiovascular Outcomes Trial, involving nearly 14,000 patients. Through international partnerships and advancing its pre-clinical pipeline, Esperion continues to evolve as a global leader in biopharmaceuticals.

The partnership between HLS and Esperion marks a significant step forward in providing Canadian patients with more comprehensive cardiovascular care options. As the regulatory process unfolds, both companies remain committed to their shared vision of improving patient outcomes in the realm of cardiovascular health.