Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715; together with its subsidiaries and/or associated companies, “Sun Pharma”) 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 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.2

Treatment guidelines now emphasize both additional LDL-C reductions and lower targets for patients with, or at very high or high, cardiovascular disease (CVD) risk, with additional therapies when statins alone are insufficient. PCSK9 inhibitors provide the efficacy and safety to achieve these goals.3 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.

“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,” said Kirti W Ganorkar, Managing Director of Sun Pharma. “This agreement marks a significant step in strengthening our global Innovative Medicines portfolio, particularly in cardiovascular care. With exclusive rights outside the United States and China, we look forward to expanding access to this important treatment option for patients globally.”

“LIB is extremely pleased to partner with Sun Pharma, a well-established global pharmaceutical company with a growing focus on innovative medicines,” said Evan Stein, MD, PhD, Chief Operating and Scientific Officer and co-founder of LIB Therapeutics. “Sun Pharma’s international presence and experience in building global innovative brands make it an ideal partner to bring lerodalcibep to more patients. Together, we aim to expand access for patients with cardiovascular disease, or at high cardiovascular risk, who need substantial additional LDL-cholesterol reductions despite existing treatment.”

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 2026.¹

Agreement terms

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.

For full prescribing information, please visit www.LEROCHOL.com.

About LEROCHOL® (lerodalcibep-liga)

LEROCHOL is a novel, antibody-mimetic, recombinant-fusion protein PCSK9 inhibitor, and is the only PCSK9 inhibitor with once-monthly, small single-injection dose, self-administered by patients with room temperature storage up to three months in a recently approved innovative autoinjector device. These features make lerodalcibep a unique alternative to other PCSK9 inhibitors. The FDA recently approved an update to the LEROCHOL indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events (MACE) achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy.

About the LIBerate Clinical Trial Program®

The FDA approval of LEROCHOL was based on data from the comprehensive global Phase 3 LIBerate Clinical Trial Program, which enrolled a diverse population of over 2,900 patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia. Lerodalcibep was dosed once monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and over 2,400 patients continued in the 72-week open-label extension trial.

In clinical trials, LEROCHOL demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very high or high risk of, cardiovascular disease and ≥59% in those with HeFH who have more severe LDL-C elevations. LEROCHOL was generally well tolerated across the LIBerate Clinical Trial Program, with no treatment-related serious adverse events reported in the long-term extension studies.

Commercial Availability

In the USA, LIB Therapeutics is committed to working with payers, healthcare providers, and patient advocacy organizations to ensure broad access to LEROCHOL for patients who need it. LIB plans to make the LEROCHOL autoinjector available in the United States by January 2027. Insurance coverage of LEROCHOL is expected to expand gradually over the course of 2027, and when launched, the autoinjector of LEROCHOL will sit alongside the pre-filled syringe in the company’s direct-to-patient cash pay program for $199 per month.

* The excluded China territory comprises mainland China, Hong Kong, Macau and Taiwan.

# Worldwide rights exclude the United States and China. Certain other excluded territories, limited in number, will be covered through separate agreements between Sun and LIB.

¹ Source: IQVIA, PCSK9 inhibitor sales at manufacturer prices in US dollars, MAT Q2 2026; two-year CAGR from MAT Q2 2024 to MAT Q2 2026. Market analysis excludes the United States, Puerto Rico and China. Figures are rounded.

2 Ray KK, Molemans B, Schoonen WM, et al. EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study. Eur J Prev Cardiol. 2021;28(11):1279-1289. doi:10.1093/eurjpc/zwaa047. The 2019 goals were applied retrospectively to data collected in 2017-2018; the 33% figure relates to patients assessed on stable therapy.

3 Mach F, Koskinas KC, Roeters van Lennep JE, et al. 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2025;46(42):4359-4378. doi:10.1093/eurheartj/ehaf190.

About LIB Therapeutics Inc.

LIB Therapeutics is a privately-held, commercial-stage biopharmaceutical company dedicated to bringing novel, highly effective, and safe therapies to help the millions of patients with cardiovascular disease and familial hypercholesterolemia finally achieve their LDL-C goals. In Greater China, a Biologics License Application has been submitted by LIB’s licensing partner Everest Medicines with potential approval in 2027. For more information, please visit: www.libtherapeutics.com.

LIB was advised and assisted by Greenhill & Co investment bank UK

About Sun Pharmaceutical Industries Limited (CIN – L24230GJ1993PLC019050)

Sun Pharma is a leading global pharmaceutical company with a presence in Innovative Medicines, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun’s high growth Global Innovative Medicines portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for about 22% of company sales. The company’s vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across five continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow them on LinkedIn & X (formerly Twitter).

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