Sun Pharmaceutical Industries Ltd has entered into an exclusive licensing agreement with LIB Therapeutics Inc to commercialise and manufacture lerodalcibep worldwide, excluding the United States and China, strengthening its presence in the global cardiovascular medicines market.
Lerodalcibep, marketed as Lyrokaul in the European Union, is a once-monthly PCSK9 inhibitor designed to lower low-density lipoprotein cholesterol (LDL-C). The drug received EU approval on September 21, 2026, and offers six-month ambient storage, which could improve convenience in distribution and use.
$3.7 billion market opportunity
The agreement gives Sun Pharma access to the PCSK9 inhibitor market outside the US and China, which reached $3.7 billion in the 12 months ended June 2026, according to IQVIA. The market has grown at a 38% CAGR over the preceding two years.
Europe accounted for $2.9 billion of the market during the same period, making it the largest component of the licensed opportunity. The global PCSK9 market is approaching $7 billion in 2026.
Under the agreement, LIB Therapeutics will receive an upfront payment and future milestone payments, along with royalties based on net sales in the licensed territories. Financial details other than these terms remain confidential.
Sun Pharma expands innovative medicines portfolio
“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 Sun Pharmaceutical Industries Ltd, Managing Director Kirti W Ganorkar.
“Sun Pharmaceutical Industries Ltd, Managing Director Kirti W Ganorkar, said the agreement marks a significant step in strengthening the company’s global Innovative Medicines portfolio, particularly in cardiovascular care. With exclusive rights outside the United States and China, Sun Pharma aims to expand access to the treatment globally.”
LIB Therapeutics said the partnership would leverage Sun Pharma’s international presence and experience in developing global innovative brands.
“LIB Therapeutics Inc, Chief Operating and Scientific Officer and co-founder Evan Stein, MD, PhD, said the company is pleased to partner with Sun Pharma and aims to expand access to lerodalcibep for patients with cardiovascular disease or those at high cardiovascular risk who need substantial additional LDL-C reductions despite existing treatment.”
Addressing LDL-C treatment gap
Lerodalcibep is approved in the EU under the Lyrokaul brand for adults with hypercholesterolaemia and mixed dyslipidaemia. In the US, where LIB retains rights, it is approved by the US FDA under the brand name Lerochol as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH).
The partnership comes amid continuing gaps between recommended LDL-C targets and real-world treatment outcomes. In the DA VINCI observational study covering 18 European countries, only 33% of patients assessed while on stable oral lipid-lowering therapy achieved their risk-based 2019 European Society of Cardiology/European Atherosclerosis Society LDL-C goals.
Treatment guidelines increasingly emphasise additional LDL-C reduction and lower targets for people at high and very high cardiovascular risk when statins alone do not achieve the required levels.
PCSK9 inhibitors are used as additional lipid-lowering therapy in such patients, creating an opportunity for wider adoption of newer treatment options.
Sun Pharma will be responsible for pursuing regulatory approvals for lerodalcibep in licensed territories where the drug has not yet received approval.