- LIB Therapeutics to receive up to $325 million in upfront and milestone payments in addition to royalties

-- Hasten obtains rights to develop and commercialize lerodalcibep in Chinese Mainland, Hong Kong, Macau, and Taiwan and will be responsible for clinical development and regulatory approval in these territories

September 12, 2023 08:00 AM Eastern Daylight Time

CINCINNATI & SHANGHAI--(BUSINESS WIRE)--LIB Therapeutics Inc. (“LIB”) and Hasten Biopharmaceutical Co., Ltd. (“Hasten”), today announce that the companies have entered into an agreement granting Hasten the rights to develop and commercialize lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan). LIB is a late-stage, biopharmaceutical company developing lerodalcibep for patients at very high and high-risk of cardiovascular disease (CVD).

“We believe that Hasten, and their experienced, knowledgeable, and motivated team of pharma professionals, is the optimal partner to bring our third-generation PCSK9 inhibitor, lerodalcibep, to the large and growing Chinese population with very-high and high risk for CVD, who need substantial additional LDL-cholesterol reductions, despite statin therapy.”

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Lerodalcibep is a next-generation, PCSK9 inhibitor in development to potentially overcome the limitations of current low-density lipoprotein (LDL-C), or ‘bad’ cholesterol, lowering treatments to achieve the new national and international guidelines to treat and prevent CVD. The convenient, small-injection volume, monthly dosing and long-ambient stability combined with excellent and sustained LDL-C efficacy of lerodalcibep, if approved, will increase the treatment options for patients, including the 30 million individuals with more severe inherited high-cholesterol, called familial hypercholesterolemia (FH).

In late August, LIB reported the global Phase 3 LIBerate-HeFH trial results of lerodalcibep in patients with heterozygous familial hypercholesterolemia (He-FH) who are very high or high-risk for CVD. These results, presented at the 2023 European Society of Cardiology (ESC) Annual Conference, demonstrated that both co-primary endpoints of LDL-C lowering were achieved. The trial enrolled 478 patients with He-FH, which effects about 1 in 300 people in China. After adjusting for placebo effect, monthly lerodalcibep resulted in placebo-adjusted reductions of mean LDL-C in the intent-to-treat population of 58.6% at Week 24 (p<0.0001) and 65.0% at the mean of Week 22 and 24 (p<0.0001). 68% of subjects on lerodalcibep achieved both a reduction in LDL-C of ≥50% and the recommended 2019 ESC LDL-C targets compared to 1.9% on placebo. Favorable tolerability and safety were observed with treatment-emergent adverse events which were generally similar between lerodalcibep and placebo.

“LIB is extremely pleased to partner with Hasten, a rapidly growing biopharmaceutical company in China with a focus on cardiovascular and metabolic care,” said Evan Stein, MD, PhD, Chief Operating and Chief Scientific Officer of LIB Therapeutics. “We believe that Hasten, and their experienced, knowledgeable, and motivated team of pharma professionals, is the optimal partner to bring our third-generation PCSK9 inhibitor, lerodalcibep, to the large and growing Chinese population with very-high and high risk for CVD, who need substantial additional LDL-cholesterol reductions, despite statin therapy.”

“Our collaboration with LIB is a significant milestone for Hasten, which marks a breakthrough in expanding and diversifying our portfolio in the field of chronic cardiovascular disease,” said Summer Xia, Chief Executive Officer of Hasten. “Furthermore, it also reflects Hasten's determination to build the research and development pipeline as well as reinforce the business strategy. Lerodalcibep is a highly promising product that will better enable Hasten to fulfill its commitment of creating value for the health of society through providing innovative products and solutions to address the unmet needs of patients. We look forward to working with LIB to bring lerodalcibep to patients in Greater China as soon as possible.”

Under the terms of the agreement, LIB has granted Hasten the exclusive rights to develop and commercialize lerodalcibep in Greater China. In return, LIB will receive an upfront payment of $20 million. LIB is eligible to receive future milestone payments of up to $305 million that are triggered upon achievement of certain clinical, regulatory, and commercial milestones. LIB is also entitled to royalties as a percentage of net sales in Greater China.

Hasten will be responsible for clinical development, regulatory and commercialization in Greater China. A joint steering committee will be established to ensure alignment of lerodalcibep’s development in Greater China with LIB’s overall global development and commercialization strategy. Hasten intends to submit an Investigational New Drug (IND) application to the China National Medical Products Administration (NMPA) at the end of this year and begin Phase 3 clinical trials for hypercholesterolemia treatment in Greater China thereafter and anticipates launching this drug in China as early as possible.

About Lerodalcibep

Lerodalcibep is a next-generation, PCSK9 inhibitor in development to potentially overcome the limitations of current low-density lipoprotein (LDL-C), or ‘bad’ cholesterol, lowering treatments to achieve new national and international guidelines to treat and prevent cardiovascular disease (CVD). The convenient, small-injection volume, monthly dosing and long-ambient stability combined with excellent and sustained LDL-C efficacy of lerodalcibep, if approved, will increase the treatment options for patients, including the 30 million individuals with more severe inherited high-cholesterol, called familial hypercholesterolemia (FH). LIB Therapeutics expects to submit a biologics license application (BLA) with FDA in Q1 2024 and marketing authorization application (MAA) with EMA in Q2 2024.

About Phase 3 LIBerate Program

LIBerate is a large, comprehensive global Phase 3 program composed of 5 key studies with lerodalcibep in over 2,500 patients in patients with cardiovascular (CVD), very high and high-risk for CVD, heterozygous familial hypercholesterolemia (He-FH) and homozygous FH (Ho-FH). The Phase 3 studies LIBerate-HoFH (LIB-003-003, n=65) and LIBerate-HeFH (LIB-003-004, n=479) have completed and met their primary endpoints. The final two Phase 3 pivotal trials, LIBerate-CVD (LIB-003-005, n=923) and LIBerate-HR (LIB-003-006, n=923), added to maximally tolerated oral lipid-lowering therapies to assess LDL-lowering in CVD, very high and high-risk for CVD patients are anticipated to complete in early November.

About LIB Therapeutics

LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing novel, safe and convenient subcutaneous and oral PCSK9 inhibitors to the millions of patients with cardiovascular disease, and the 30 million individuals with familial hypercholesterolemia (FH), who require additional large reductions in low density lipoprotein-cholesterol (LDL-C) despite maximally tolerated statins and other lipid lowering agents.

About Hasten Biopharmaceutical Company

Hasten Biopharmaceutical Co., Ltd., which integrates R&D, production and commercial promotion and covers the whole industrial chain, was established in 2020. Hasten is committed to becoming a leader in the healthcare industry. Through joining hands with the stakeholders such as relevant government institutions, medical and health professionals and industry partners, Hasten provides high-quality medicines and solutions to benefit patients and create social value.

Contacts

For further information please contact:

LIB Therapeutics Inc.
Kate Caldwell, Senior Director of Clinical Development
Email: kcaldwell@libtherapeutics.com
www.libtherapeutics.com

Hasten Biopharmaceutical Co., Ltd.
Angela Zhou, Head of Corporate Communication
Email: angela.zhou@hastenpharma.com
https://www.hastenpharma.com/en/

Resource:- Businesswire