Sun Pharmaceutical Industries has entered into an exclusive licensing agreement with LIB Therapeutics to commercialise and manufacture lerodalcibep, a PCSK9 inhibitor used to lower LDL cholesterol, across global markets outside the US and China.
The agreement gives Sun Pharma exclusive rights to the drug in licensed territories, while LIB Therapeutics will receive upfront and future milestone payments, along with royalties based on net sales. Other financial terms of the agreement remain confidential.
The development comes after lerodalcibep received approval in the European Union on September 21, under the brand name Lyrokaul. The drug is administered once a month and is designed to reduce low-density lipoprotein cholesterol (LDL-C), commonly known as bad cholesterol.
Sun Pharma gets access to $3.7 billion PCSK9 market
The deal gives Sun Pharma access to the PCSK9 inhibitor market outside the US and China, which reached $3.7 billion in the 12 months ended Q2 2026, according to IQVIA data cited by the company.
The market grew at a 38% compound annual growth rate over the preceding two years. Europe accounted for $2.9 billion of the market during the same period. The global PCSK9 market is approaching $7 billion in 2026, Sun Pharma said.
Sun Pharma to expand cardiovascular portfolio
Sun Pharma said the agreement will strengthen its Global Innovative Medicines portfolio, particularly in cardiovascular care.
“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,” he added.
In Europe, Lyrokaul can be stored at room temperature of up to 25°C for up to six months after being removed from refrigeration. This is intended to provide greater flexibility for patients at home and while travelling.
Drug already approved in US
Lerodalcibep is a novel antibody-mimetic biologic and recombinant fusion protein that inhibits PCSK9. It is given as a 300 mg/1.2 mL subcutaneous injection once a month.
In the US, the drug has already received approval from the US Food and Drug Administration under the brand name Lerochol.
In the EU, Lyrokaul is indicated for adults with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, as well as mixed dyslipidaemia.
It can be used with a statin or other lipid-lowering therapies when patients are unable to reach their LDL-C goals with the maximum tolerated dose of a statin. It can also be used alone or with other lipid-lowering therapies in patients who cannot tolerate statins or for whom statins are contraindicated.
Sun Pharma to pursue regulatory approvals
Under the agreement, Sun Pharma will be responsible for pursuing regulatory approvals in the licensed territories where lerodalcibep has not yet been approved.
The agreement excludes the US and China. The China exclusion covers mainland China, Hong Kong, Macau and Taiwan.
LIB Therapeutics said it sees Sun Pharma’s international presence and experience in building global innovative brands as important to expanding access to lerodalcibep.
“Sun Pharma’s international presence and experience in building global innovative brands make it an ideal partner to bring lerodalcibep to more patients,” said Evan Stein, MD, PhD, Chief Operating and Scientific Officer and co-founder of LIB Therapeutics.
Injection-site reactions among common side effects
According to the product information, the most frequently reported adverse reactions include injection-site reactions, injection-site erythema and injection-site bruising.
Injection-site reactions occurred in 11.6% of patients treated with lerodalcibep in pivotal studies. Most were mild or moderate in severity, while 1% of patients discontinued treatment because of injection-site reactions.
Sun Pharma said the partnership addresses the need for additional LDL-C reduction among patients who remain above recommended cholesterol targets despite existing treatment.