Sun Pharmaceutical Industries and LIB Therapeutics Inc. (LIB) today announced:

• An exclusive licensing agreement granting Sun Pharma rights to commercialize and manufacture lerodalcibep worldwide, excluding the United States and China.
• Lyrokaul (lerodalcibep), a once-monthly PCSK9 inhibitor for LDL-C lowering, comes with 6-month EU ambient storage; received EU approval on September 21, 2026.
• Strengthens Sun Pharma's Innovative Medicines portfolio through access to a US$3.7 billion PCSK9 market Ex-US and China, growing at 38% CAGR; global PCSK9 market approaching US$7 billion in 2026.1
• LIB will receive an upfront and future milestone payments, together with royalties based on net sales in the licensed territories.

Lerodalcibep is approved in the EU under the brand name Lyrokaul for the treatment of adult patients with hypercholesterolaemia and mixed dyslipidaemia. In the United States, it is US FDA-approved under the brand name Lerochol as an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

The partnership helps address a significant global unmet need in cardiovascular care. Many patients at high or very high cardiovascular risk remain above recently updated and more globally harmonized 2026 guideline recommended LDL-cholesterol (LDL-C) goals despite treatment. In the DA VINCI observational study across 18 European countries, only 33% of patients assessed on stable oral lipid-lowering therapy achieved their risk-based 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) LDL-C goals.

Treatment guidelines now emphasise both additional LDL-C reductions and lower targets for patients at high and very high cardiovascular risk, with additional therapies when statins alone are insufficient. PCSK9 inhibitors provide the efficacy and safety to achieve these goals.4 This gap between treatment goals and real-world control reinforces the opportunity for Sun Pharma and LIB to broaden access to innovative lipid-lowering care across Europe and Sun's world-wide licensed markets.

The agreement establishes a significant new growth platform for Sun Pharma in a large and rapidly expanding market. According to IQVIA, the PCSK9 inhibitor market outside the United States and China reached US$ 3.7 billion in the period ending Q2 2026 (MAT Q2 2026), growing at 38% CAGR over the preceding two years. Europe alone accounted for US$ 2.9 billion PCSK9 inhibitor market in MAT Q2 2026.

LIB will receive an upfront and future milestone payments, together with royalties based on net sales in the licensed territories. Other terms of the agreement are confidential. Sun Pharma will be responsible for pursuing regulatory approvals in licensed territories where approval has not yet been obtained.