Partnership Agreement Details
Sun Pharmaceutical Industries Limited and LIB Therapeutics Inc. announced an exclusive global licensing agreement granting Sun Pharma rights to commercialize and manufacture lerodalcibep worldwide, excluding the United States and China. The agreement covers territories outside US and China, with certain other excluded territories to be covered through separate agreements.
Product Information and Regulatory Status
Lerodalcibep is a once-monthly PCSK9 inhibitor for LDL-C lowering with 6-month ambient storage capability. The product received EU approval on September 21, 2026, under the brand name Lyrokaul for treatment of adult patients with hypercholesterolaemia and mixed dyslipidaemia. In the United States, it is FDA-approved under the brand name Lerochol as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Market Opportunity and Strategic Impact
The partnership addresses a significant global unmet need in cardiovascular care, targeting a US$3.7 billion PCSK9 inhibitor market outside United States and China (MAT Q2 2026), growing at 38% CAGR over preceding two years. Europe alone accounted for US$2.9 billion PCSK9 inhibitor market in MAT Q2 2026. This agreement strengthens Sun Pharma's Innovative Medicines portfolio, particularly in cardiovascular care, and establishes a significant new growth platform.
Financial Terms
LIB Therapeutics will receive upfront and future milestone payments, together with royalties based on net sales in the licensed territories. Other terms of the agreement remain confidential. Sun Pharma will be responsible for pursuing regulatory approvals in licensed territories where approval has not yet been obtained.
Clinical and Product Specifications
Lerodalcibep is a novel antibody-mimetic biologic and recombinant fusion protein that inhibits PCSK9, delivered as once monthly 300 mg/1.2 mL subcutaneous injection. The EU label permits storage in original carton at room temperature up to 25°C for up to six months after removal from refrigeration. In US, it is approved in both autoinjector and prefilled-syringe presentations.
Therapeutic Indications and Safety Profile
LYROKAUL is indicated in adults with primary hypercholesterolaemia or mixed dyslipidaemia as adjunct to diet, either in combination with statin or other lipid-lowering therapies, or alone in statin-intolerant patients. The most frequently reported adverse reactions are injection site reaction (6.7%), injection site erythema (3.6%), and injection site bruising (1.6%). The proportion of patients who discontinued treatment due to injection site reactions was 1.0%.
Management Commentary
Kirti W Ganorkar, Managing Director of Sun Pharma, stated: "Once-monthly lerodalcibep dosing, with robust LDL-C reduction and the added benefits of a small-volume injection and six-month ambient storage, simplifies treatment for patients and offers greater convenience. This agreement marks a significant step in strengthening our global Innovative Medicines portfolio."
Evan Stein, MD, PhD, Chief Operating and Scientific Officer of LIB Therapeutics, commented: "LIB is extremely pleased to partner with Sun Pharma, a well-established global pharmaceutical company with a growing focus on innovative medicines. Sun Pharma's international presence and experience in building global innovative brands make it an ideal partner."
Clinical Context and Market Need
The partnership addresses the gap between treatment goals and real-world control, where only 33% of patients assessed on stable oral lipid-lowering therapy achieved their risk-based 2019 ESC/EAS LDL-C goals according to the DA VINCI observational study across 18 European countries. Updated treatment guidelines emphasize additional LDL-C reductions and lower targets for high-risk patients.
About the Companies
LIB Therapeutics Inc is a privately-held, commercial-stage biopharmaceutical company dedicated to bringing novel therapies for cardiovascular disease and familial hypercholesterolemia. LIB was advised by Greenhill & Co investment bank UK.
Sun Pharma is a leading global pharmaceutical company with presence in Innovative Medicines, Generics and Consumer Healthcare products, with Innovative Medicines accounting for about 22% of company sales. The company operates in over 100 countries with manufacturing facilities across five continents.