NSEPress Release28 Sept 2026 · 28 Sept 2026, 08:20 am
Press Release
Sun Pharmaceutical Industries Limited · SUNPHARMA
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Sun Pharmaceutical Industries Limited has entered into a licensing agreement with LIB Therapeutics Inc. for the commercialization and manufacturing of lerodalcibep, a PCSK9 inhibitor, in territories outside the United States and China. The agreement grants Sun Pharma exclusive rights to the drug, which has received EU approval and is approved in the US under a different brand name.
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Sun Pharmaceutical Industries Limited has informed the Exchange regarding a press release for Lerodalcibep licensing agreement.
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Sun Pharmaceutical Industries Limited
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E),
Mumbai – 400 063, Maharashtra, INDIA.
Tel.: (91-22) 4324 4324
Fax: (91-22) 4324 4343
Website: www.sunpharma.com
Email: secretarial@sunpharma.com
CIN: L24230GJ1993PLC019050
28 September 2026
National Stock Exchange of India Limited BSE Limited
Scrip Symbol: SUNPHARMA Scrip Code: 524715
Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations,
2015 – Press Release
Enclosed herewith is a copy of the press release titled “LIB Therapeutics and Sun Pharma Announce Global
Licensing, Commercialization and Manufacturing Agreement for Lerodalcibep, a PCSK9 Inhibitor, Ex-US and
China; Lyrokaul (lerodalcibep) Approved in the EU” which shall be released after this intimation.
For Sun Pharmaceutical Industries Limited
(Anoop Deshpande)
Company Secretary and Compliance Officer
ICSI Membership No.: A23983
Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA.
Reaching People. Touching Lives.
Sun Pharmaceutical Industries Limited
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E),
Mumbai – 400 063, Maharashtra, INDIA.
Tel.: (91-22) 4324 4324
Fax: (91-22) 4324 4343
Website: www.sunpharma.com
Email: secretarial@sunpharma.com
CIN: L24230GJ1993PLC019050
FOR IMMEDIATE RELEASE
LIB Therapeutics and Sun Pharma Announce Global Licensing, Commercialization and
Manufacturing Agreement for Lerodalcibep, a PCSK9 Inhibitor, Ex-US and China; Lyrokaul
(lerodalcibep) Approved in the EU
Mumbai, India and Cincinnati, Ohio, United States, September 28, 2026 – Sun Pharmaceutical Industries
Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715; together with its
subsidiaries and/or associated companies, “Sun Pharma”) and LIB Therapeutics Inc. (“LIB”) today announced:
• An exclusive licensing agreement granting Sun Pharma rights to commercialize and manufacture
lerodalcibep worldwide, excluding the United States and China.
• Lyrokaul (lerodalcibep), a once-monthly PCSK9 inhibitor for LDL-C lowering, comes with 6-month EU
ambient storage; received EU approval on September 21, 2026.
• Strengthens Sun Pharma’s Innovative Medicines portfolio through access to a US$3.7 billion PCSK9 market
Ex-US and China, growing at 38% CAGR; global PCSK9 market approaching US$7 billion in 2026.1
• LIB will receive an upfront and future milestone payments, together with royalties based on net sales in the
licensed territories.
Lerodalcibep is approved in the EU under the brand name Lyrokaul for the treatment of adult patients with
hypercholesterolaemia and mixed dyslipidaemia. 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 partnership helps address a significant global unmet need in cardiovascular care. Many patients at high or
very high cardiovascular risk remain above recently updated and more globally harmonized 2026 guideline-
recommended LDL-cholesterol (LDL-C) goals despite treatment. 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.3
Treatment guidelines now emphasise both additional LDL-C reductions and lower targets for patients at high and
very high cardiovascular risk, with additional therapies when statins alone are insufficient. PCSK9 inhibitors
provide the efficacy and safety to achieve these goals.4 This gap between treatment goals and real-world control
reinforces the opportunity for Sun Pharma and LIB to broaden access to innovative lipid-lowering care across
Europe and Sun’s world-wide licensed markets.
“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.”
Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA.
Reaching People. Touching Lives.
Sun Pharmaceutical Industries Limited
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E),
Mumbai – 400 063, Maharashtra, INDIA.
Tel.: (91-22) 4324 4324
Fax: (91-22) 4324 4343
Website: www.sunpharma.com
Email: secretarial@sunpharma.com
CIN: L24230GJ1993PLC019050
“LIB is extremely pleased to partner with Sun Pharma, a well-established global pharmaceutical company with a
growing focus on innovative medicines,” said Evan Stein, MD, PhD, Chief Operating and Scientific Officer and
co-founder of LIB Therapeutics. “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.”
The agreement establishes a significant new growth platform for Sun Pharma in a large and rapidly expanding
market. According to IQVIA, the PCSK9 inhibitor market outside the United States and China reached US$ 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 US$ 2.9 billion PCSK9 inhibitor market in MAT Q2 2026.¹
Agreement terms
LIB will receive an upfront and future milestone payments, together with royalties based on net sales in the
licensed territories. Other terms of the agreement are confidential. Sun Pharma will be responsible for pursuing
regulatory approvals in licensed territories where approval has not yet been obtained.
About lerodalcibep2
Lerodalcibep is a novel antibody-mimetic biologic and recombinant fusion protein that inhibits proprotein
convertase subtilisin/kexin type 9 (PCSK9). It helps deliver sustained reductions in low-density lipoprotein
cholesterol (LDL-C), often called “bad” cholesterol, with once monthly 300 mg/1.2 mL subcutaneous injection.
Recently, lerodalcibep has received marketing authorisation from European Medicines Agency under the brand
name Lyrokaul. The EU label permits storage in the original carton at room temperature up to 25°C for up to six
months after removal from refrigeration, offering flexibility for patients at home and while travelling.
In the United States, lerodalcibep is approved by the US FDA under the brand name Lerochol in both autoinjector
and prefilled-syringe (PFS) presentations.
SELECT CLINICAL PARTICULARS (For more information, please see full Lyrokaul Product
Information2 in EU Commission Website)
Therapeutic indications
LYROKAUL is indicated in adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-
familial) or mixed dyslipidaemia as an adjunct to diet:
• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low-
density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin, or
• alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for
whom a statin is contraindicated.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in package leaflet.
Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA.
Reaching People. Touching Lives.
Sun Pharmaceutical Industries Limited
Sun House, Plot No. 201 B/1,
Western Express Hig
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