Mumbai, September 28: Pharma major Sun Pharmaceuticals has entered into an exclusive lincensing agreement with US based LIB Therapeutics to develop and commercialise lerodalcibep, a third-generation PCSK9 inhibitor designed to treat bad cholesterol. This move grants Sun Pharma exclusive rights to the drug in all global markets except China and the US, with the therapy drug having a market potential of $3.7 billion.
Lerodalcibep has been approved for use in the European Union this month while in the US it is approved under the FDA under the brand name Lerochol. According to the agreement, LIB Therapeutics will get upfront payments on future milestones and sales royalties, even though the exact deal value remains under wraps.
Lerodalcibep represents a significant advancement in cholesterol management. As a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitor, it works by increasing the number of receptors on the liver’s surface that remove LDL cholesterol (LDL-C) from the blood. Unlike earlier generations of PCSK9 inhibitors, lerodalcibep is a monthly injection that remains stable at room temperature. Clinical data from the “LIBerate” Phase 3 program demonstrated that the drug provides sustained and significant reduction in LDL-C levels, making it a highly ideal alternative for patients who do not achieve their targets with statins alone.
“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”, Kirti W Ganorkar, Managing Director of Sun Pharma said in a press release.
“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.
