Sun Pharma Expands Cardiovascular Portfolio with Lerodalcibep
Sun Pharmaceutical Industries Ltd. (Sun Pharma) has entered into a significant exclusive licensing, commercialization, and manufacturing agreement with LIB Therapeutics Inc. for the cholesterol-lowering drug lerodalcibep. This strategic partnership grants Sun Pharma rights across global markets, explicitly excluding the United States and China.
Lerodalcibep is a potent PCSK9 inhibitor designed to effectively reduce low-density lipoprotein cholesterol (LDL-C), often referred to as "bad cholesterol." The drug, known as Lyrokaul in the European Union, received EU approval on September 21, 2026, for adults suffering from hypercholesterolaemia and mixed dyslipidaemia. It is administered as a convenient once-monthly 300 mg subcutaneous injection.
Market Opportunity and Patient Benefits
The agreement positions Sun Pharma to tap into a rapidly expanding market for PCSK9 inhibitors. According to IQVIA, the market for these drugs outside the US and China reached an estimated US$3.7 billion in the 12 months ending Q2 2026, demonstrating a robust 38% Compound Annual Growth Rate (CAGR) over the preceding two years. Europe alone constituted a substantial US$2.9 billion of this market during the period.
Kirti W Ganorkar, Managing Director of Sun Pharma, highlighted the patient-centric advantages of lerodalcibep. "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," Ganorkar stated. He emphasized that this deal significantly strengthens Sun Pharma's global innovative medicines portfolio, particularly within cardiovascular care.
Terms of the Agreement
Under the terms of the licensing deal, Sun Pharma will assume responsibility for pursuing regulatory approvals in all licensed territories where lerodalcibep has not yet been approved. LIB Therapeutics will receive an upfront payment, subsequent milestone payments, and royalties based on net sales generated in these licensed regions. The precise financial details beyond these general terms remain confidential.
While lerodalcibep has also secured US FDA approval under the brand name Lerochol, Sun Pharma's commercialization rights are specifically tailored to markets outside the US and China. A key benefit for patients in the EU is the drug's ability to be stored at room temperature (up to 25°C) for six months after initial refrigeration, providing enhanced flexibility and ease of use.