HLS Therapeutics Announces NILEMDOTM (bempedoic acid) is now available in Canada for the Reduction of LDL-Cholesterol in Patients at Risk of Cardiovascular Disease

Executive Summary

• HLS Therapeutics announced the Canadian commercial launch of NILEMDO™ (bempedoic acid), a first‑in‑class, once‑daily oral non‑statin therapy for LDL‑cholesterol reduction.
• The product is now available by prescription nationwide following Health Canada approval in November 2025; HLS holds exclusive Canadian rights licensed from Esperion Therapeutics.
• HLS projects coverage by private payers in Q2 2026 and seeks public reimbursement later in 2026, with a follow‑on combination pill (NEXLIZET) slated for a 2027 launch.

Key Details

• Product & Indication: NILEMDO™ (bempedoic acid) – indicated to lower LDL‑C and reduce major adverse cardiovascular events (MACE) in adults unable to achieve target LDL‑C with existing therapies or who are statin intolerant.
• Regulatory Status: Health Canada approval received November 2025; eight‑year data protection from 17 Nov 2025, extending market exclusivity until 2040.
• Licensing Arrangement: HLS in‑licensed exclusive Canadian rights to NILEMDO™ and NEXLIZET® (bempedoic acid/ezetimibe) from Esperion Therapeutics in May 2025.
• Clinical Evidence: Supported by the CLEAR Outcomes trial (≈14,000 high‑risk patients) showing statistically significant reductions in cardiovascular death, non‑fatal MI, non‑fatal stroke, and coronary revascularization.
• Target Population: Estimated > 500,000 Canadians could benefit from NILEMDO™ based on unmet LDL‑C lowering needs.
• Reimbursement Outlook: Submission underway for both private and public formularies; meaningful private payer coverage expected in Q2 2026, public reimbursement anticipated late 2026.
• Future Pipeline – NEXLIZET: Combination pill (bempedoic acid + ezetimibe) demonstrated ~38 % LDL‑C reduction in trials; regulatory submission ongoing with a projected commercial launch in 2027 pending Health Canada clearance.
• Strategic Impact: CEO Craig Millian stated the launch “strengthens our cardiovascular portfolio and, along with Vascepa®, positions HLS as a leader in bringing novel oral cardiovascular medicines to the Canadian market.”

Notable Quotes

• “With the launch of NILEMDO, Canadians who have been unable to reach their LDL‑C targets now have a new oral treatment option supported by robust cardiovascular outcomes data,” – Craig Millian, CEO, HLS Therapeutics.
• “Bempedoic acid (NILEMDO) offers a new option for Canadian patients who cannot achieve their LDL‑C goal or are intolerant to statins,” – Dr. Lawrence Leiter, Professor of Medicine and Nutritional Sciences, University of Toronto.