Sun Pharmaceutical Industries has entered into an exclusive licensing agreement with LIB Therapeutics to commercialize and manufacture lerodalcibep across global markets outside the United States and China. The agreement gives Sun Pharma access to a once-monthly PCSK9 inhibitor designed to lower low-density lipoprotein cholesterol, or LDL-C, and expands the company’s presence in the growing cardiovascular medicines market.
The deal adds lerodalcibep to Sun Pharma’s Innovative Medicines portfolio at a time when demand for therapies that help patients achieve lower LDL-C levels is increasing. The company will hold commercialization and manufacturing rights across the licensed territories, while LIB Therapeutics will receive upfront payments, milestone payments and royalties linked to net sales.
The agreement also strengthens Sun Pharma’s position in cardiovascular drugs, particularly in the PCSK9 inhibitor segment. According to market data cited in the announcement, the PCSK9 inhibitor market outside the US and China reached approximately $3.7 billion in the 12 months through the second quarter of 2026 and has been growing at a 38% CAGR. The broader global PCSK9 inhibitor market is projected to approach $7 billion in 2026.
Lerodalcibep is administered once a month and works by inhibiting PCSK9, a protein involved in the regulation of LDL receptors. By preventing PCSK9 from promoting the breakdown of these receptors, the treatment helps the liver remove more LDL cholesterol from the bloodstream.
The product has received regulatory clearance in Europe under the name Lyrokaul. The European Medicines Agency describes lerodalcibep as a lipid-modifying medicine for adults with primary hypercholesterolaemia or mixed dyslipidaemia who cannot achieve their LDL-C goals with statins or who cannot tolerate statin treatment.
Sun Pharma Targets Growing PCSK9 Treatment Market
The licensing agreement gives Sun Pharma an opportunity to build a larger presence in a segment that has expanded as treatment guidelines have placed greater emphasis on LDL-C reduction among patients at high and very high cardiovascular risk.
The commercial opportunity is particularly notable in Europe and other markets outside the US and China. Europe alone accounted for approximately $2.9 billion of the ex-US and China PCSK9 inhibitor market during the period cited in the announcement. The size and growth of the segment provide Sun Pharma with an additional avenue for expanding its Innovative Medicines business.
Lerodalcibep’s dosing schedule is another factor in its positioning. The treatment is designed to be administered once every month, offering an alternative to more frequent dosing schedules used by some lipid-lowering therapies. The European formulation is supplied as a 300 mg solution for injection in pre-filled syringes.
The medicine is intended for adults with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, and mixed dyslipidaemia. It can be used alongside a statin or other lipid-lowering treatments when patients do not reach their LDL-C targets, while it may also be used in patients who are unable to take statins.
The commercial rationale for the agreement is also linked to the gap between treatment recommendations and actual LDL-C control. Data from the DA VINCI observational study cited by the companies showed that only 33% of patients receiving stable oral lipid-lowering therapy in Europe reached their recommended LDL-C goals.
That finding highlights the continuing need for additional treatment options for patients who remain above recommended cholesterol levels despite existing therapy. PCSK9 inhibitors can provide another approach for patients requiring substantial additional LDL-C reduction.
For Sun Pharma, the agreement is therefore not simply an expansion into another pharmaceutical category. It gives the company access to a product with established regulatory progress and a market where treatment demand is expanding. The company will now be responsible for commercializing and manufacturing lerodalcibep across its licensed territories.
The agreement comes shortly after the European regulatory process advanced for the product. The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for Lyrokaul in July 2026, recommending its authorization for adults with hypercholesterolaemia and mixed dyslipidaemia.
Lerodalcibep Expands Sun Pharma’s Innovative Medicines Portfolio
Sun Pharma has been increasing its focus on specialty and innovative medicines alongside its established generic pharmaceutical business. The addition of lerodalcibep gives that portfolio another product in a large chronic disease category, with cardiovascular care representing a substantial global treatment market.
Kirti W. Ganorkar, Managing Director of Sun Pharma, said the agreement would strengthen the company’s Innovative Medicines portfolio and expand its presence in cardiovascular care. The company expects the product to help address the gap between recommended LDL-C levels and the outcomes achieved by patients receiving conventional lipid-lowering treatment.
For LIB Therapeutics, the agreement provides a partner with an established international commercial and manufacturing presence. Evan Stein, MD, PhD, Chief Operating and Scientific Officer of LIB Therapeutics, said the collaboration could help broaden access to lerodalcibep for patients across the licensed markets.
The product’s international positioning could also benefit from its storage characteristics. The company has highlighted the ability of lerodalcibep to remain at ambient temperature for six months after removal from refrigeration, at temperatures up to 25 degrees Celsius. This could have practical implications for distribution and handling across markets with different healthcare infrastructure.
The commercial rollout will nevertheless require Sun Pharma to navigate individual market requirements, pricing decisions, reimbursement systems and local regulatory processes. The licensing agreement provides commercialization rights, but adoption across different countries will depend on those market-specific factors.
Competition will also remain significant. The PCSK9 inhibitor category includes established therapies, while other lipid-lowering approaches continue to develop. Sun Pharma’s ability to establish lerodalcibep across its licensed territories will therefore depend on how physicians, payers and patients assess its clinical profile, dosing schedule, cost and place within existing treatment pathways.
The deal gives Sun Pharma rights across a broad geographic footprint while excluding two of the world’s largest pharmaceutical markets, the United States and China. That structure leaves the company with a substantial international opportunity while LIB Therapeutics retains commercial control in those excluded markets.
With the PCSK9 segment expanding and LDL-C targets becoming increasingly important in cardiovascular risk management, lerodalcibep gives Sun Pharma a new product around which it can build its international cardiovascular business. The agreement also illustrates the company’s broader effort to add differentiated therapies to its Innovative Medicines portfolio rather than relying solely on its traditional pharmaceutical categories.
As commercialization progresses, the focus will shift toward regulatory execution, market access and physician adoption across the licensed countries. For Sun Pharma, the deal provides a new platform in cardiovascular drugs and a potential long-term growth opportunity in a rapidly expanding segment of lipid management.
ref: https://tradealone.com/news/healthcare/sun-pharma-global-licensing-lerodalcibep-september-2026
