Sun Pharmaceutical Industries and LIB Therapeutics Inc. (LIB) have announced an exclusive licensing agreement granting Sun Pharma rights to commercialize and manufacture lerodalcibep worldwide, excluding the United States and China. According to reports from CNBC TV18 and Business Standard, the agreement establishes a significant new growth platform for Sun Pharma in a large and rapidly expanding market. LIB will receive upfront and future milestone payments, together with royalties based on net sales in the licensed territories, with other terms of the agreement remaining confidential. As per CNBC TV18, Sun Pharma entered this agreement with its subsidiaries, strengthening the company's Innovative Medicines portfolio through access to a $3.7 billion PCSK9 market ex-US and China, which is growing at 38% CAGR. The deal comes days after the European Union approved Lerodalcibep under the brand name Lyrokaul on September 21, 2026, for adults with high cholesterol and mixed dyslipidaemia. The agreement underscores Sun Pharma's disciplined approach to building its specialty portfolio by bypassing the highly competitive and cost-intensive US and China territories to target the rapidly expanding ex-US/China market.
Lyrokaul (lerodalcibep), a once-monthly PCSK9 inhibitor for LDL-C lowering, comes with 6-month EU ambient storage and received EU approval on September 21, 2026. As reported by CNBC TV18 and Business Standard, in the United States, it is US FDA-approved under the brand name Lerochol as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). The drug is approved in the EU under the brand name Lyrokaul for the treatment of adult patients with hypercholesterolaemia and mixed dyslipidaemia. According to CNBC TV18, lerodalcibep is a novel antibody-mimetic biologic and recombinant fusion protein that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), helping deliver sustained reductions in low-density lipoprotein cholesterol with once monthly 300 mg/1.2 ml subcutaneous injection. The 6-month ambient room-temperature storage capability of Lyrokaul provides a distinct convenience advantage over legacy refrigerated PCSK9 inhibitors, making it highly attractive for out-of-hospital use and potentially accelerating clinical adoption. In the EU, Lyrokaul can be kept at room temperature of up to 25 degrees Celsius for six months after being removed from refrigeration, offering significant operational advantages for healthcare providers. In Europe, the treatment can be used with statins or other lipid-lowering therapies when LDL cholesterol goals are not achieved, and in certain patients who cannot tolerate statins. Injection-site reactions, including redness and bruising, were among the most frequently reported adverse effects in clinical studies.
According to IQVIA data reported by CNBC TV18 and Business Standard, the PCSK9 inhibitor market outside the United States and China reached $3.7 billion in the period ending Q2 2026 (MAT Q2 2026), growing at 38% CAGR over the preceding two years. Europe alone accounted for $2.9 billion PCSK9 inhibitor market in MAT Q2 2026. The partnership helps address a significant global unmet need in cardiovascular care, with the global PCSK9 market projected to approach $7 billion in 2026. In the DA VINCI observational study across 18 European countries, only 33% of patients assessed on stable oral lipid-lowering therapy achieved their risk-based 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) LDL-C goals. As reported by CNBC TV18 and Business Standard, many patients at high or very high cardiovascular risk remain the recently-updated and more globally harmonized 2026 guidelines recommended LDL-cholesterol goals despite treatment. The entry into European and other emerging market cardiovascular spaces will diversify Sun Pharma's specialty revenue, with the licensing deal providing direct entry into the high-potential lipid-lowering therapies market in Europe and other international markets.
As reported by CNBC TV18 and Business Standard, the agreement strengthens Sun Pharma's Innovative Medicines portfolio through access to a $3.7 billion PCSK9 market ex-US and China, which is growing at 38% CAGR. Sun Pharma will be responsible for pursuing regulatory approvals in licensed territories where approval has not yet been obtained. According to CNBC TV18, Sun Pharma managing director Kirti W Ganorkar stated that 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. The licensing deal shifts Sun Pharma's innovative pipeline focus further into cardiovascular treatments, capitalizing on the recent September 21, 2026, European approval of lerodalcibep (Lyrokaul). The partnership reinforces the opportunity for broadening access to innovative lipid-lowering care across Europe and Sun's worldwide licensed markets, addressing the gap between treatment goals and real-world control in cardiovascular care. Treatment guidelines now emphasize both additional LDL-C reductions and lower targets for patients at high and very high cardiovascular risk, with PCSK9 inhibitors providing the efficacy and safety to achieve these goals.
Brokerage firm Macquarie noted that with the agreement, Sun Pharma is moving into cardiovascular therapy to leverage the Organon platform and expects more cross-selling opportunities with this licensing deal. It maintained an 'Outperform' rating on Sun Pharma shares with a target price of ₹2,150 apiece, implying an upside potential of nearly 17% from Monday's closing price. As reported by CNBC TV18, shares of Sun Pharmaceutical Industries Ltd. were in focus on Monday, September 28, after announcing the licensing agreement, but the stock ended the session 0.73% lower at ₹1,840.00 apiece on the BSE. 360 One Capital maintained a 'Buy' call and a Sun Pharma share price target of ₹2,250 apiece, implying an upside potential of more than 22%. In its Q1 FY27, Sun Pharma reported a consolidated net profit of ₹2,894.8 crore, representing a 27.08% year-on-year increase from ₹2,278.6 crore in Q1 FY26. Supported by solid domestic growth of 16% in Q1 FY27, this deal secures a new specialty growth driver for the company. While near-term R&D or milestone payout obligations may marginally increase operating outlays, the long-term, high-margin profile of novel biologics is structurally positive for the company's consolidated EBITDA margin, strengthening Sun Pharma's global positioning as a specialty pharmaceutical player.
