Sun Pharma bags rights to $3.7 billion cholesterol drug market globally

Sun Pharmaceutical Industries has signed a global licensing deal with US-based LIB Therapeutics for Lerodalcibep, a once-monthly drug used to lower “bad” cholesterol, giving it exclusive rights to commercialise and manufacture the medicine outside the US and China, the company said in an exchange filing on Monday.

The deal gives Sun Pharma access to a $3.7 billion market for PCSK9 inhibitors, a class of cholesterol-lowering medicines. The market outside the US and China grew at a compound annual growth rate of 38 per cent over the two years to June 2026, according to IQVIA data cited by the companies. Europe alone accounted for $2.9 billion of the market.

The agreement comes days after the European Union approved Lerodalcibep under the brand name Lyrokaul. The drug was approved on September 21 for adults with high cholesterol and mixed dyslipidaemia.

Under the deal, LIB Therapeutics will receive an upfront payment, milestone payments and royalties based on sales in Sun Pharma’s licensed markets. The companies have not disclosed the financial terms. Sun Pharma will also seek regulatory approvals in markets where the drug is not yet approved.

What is Lerodalcibep?

Lerodalcibep is a PCSK9 inhibitor that reduces levels of low-density lipoprotein cholesterol (LDL-C), commonly known as bad cholesterol. It is given once a month through a 300 mg injection under the skin.

Its EU approval covers adults with primary hypercholesterolaemia, including inherited high cholesterol, and mixed dyslipidaemia. It can be used with a statin when patients do not reach their LDL-C targets, or on its own or with other cholesterol-lowering medicines when statins cannot be used.

One feature that could make the drug easier to use is its storage requirement. In the EU, Lyrokaul can be kept at room temperature of up to 25 degrees Celsius for six months after being removed from refrigeration.

Lerodalcibep is already approved in the US under the brand name Lerochol. The US market, however, is not part of Sun Pharma’s agreement, and neither is China.

Why the market matters

The companies said the deal addresses a gap in cholesterol treatment. Despite existing medicines, many high-risk patients do not reach recommended LDL-C levels. A European observational study cited in the release found that only 33 per cent of patients assessed on stable oral lipid-lowering treatment had reached their risk-based LDL-C goals.

“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,” said Kirti W Ganorkar, managing director, Sun Pharma.

“Once-monthly” dosing and the ability to store the medicine at room temperature for six months could also make the treatment more convenient for patients, the company said.

Sun Pharma will now be responsible for commercialising the drug in its licensed territories and pursuing approvals where required. LIB Therapeutics will continue to receive payments linked to the drug’s development and sales.

“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,” said Evan Stein, chief operating and scientific officer and co-founder of LIB Therapeutics.