Danish multinational pharmaceutical company Novo Nordisk and Japanese cardiac regenerative medicine specialist Heartseed have confirmed an exclusive global partnership and license agreement for the development, production, and commercialization of Heartseed’s key asset cell-based therapy, HS-001.
Cell therapy for the treatment of heart failure caused by ischemic heart disease
Heartseed is actively developing HS-001, an experimental cell therapy for the treatment of heart failure that uses refined cardiomyocytes produced from induced pluripotent stem cells (iPSC). In the second half of 2021, Heartseed plans to start a phase 1/2 clinical study in Japan (LAPiS Study) to assess the safety and effectiveness of HS-001 for the treatment of heart failure caused by ischemic heart disease. Heartseed’s Clinical Study Application to conduct the clinical trial has been authorized by Japan’s Pharmaceutical and Medical Devices Agency.
Terms of the agreement
Except in Japan, Novo Nordisk will have exclusive rights to develop, manufacture, and market HS-001 under the terms of the deal. Heartseed will retain the exclusive right to develop HS-001 in Japan, while Novo Nordisk is entitled to co-commercialize the product with Heartseed in Japan at a 50/50 profit and cost split. Heartseed has the potential to collect up to $598 million in payments, including $55 million in upfront and near-term milestone payments. Outside of Japan, Heartseed is also eligible for tiered royalties ranging from the high single digits to the low double digits of yearly net sales.
Keiichi Fukuda, CEO of Heartseed stated:
“We are delighted to have a company with the expertise and resources of Novo Nordisk as our partner for development and commercialisation of HS-001, and are also honoured that Novo Nordisk has recognised the innovativeness and high potential of our technology. We believe that the partnership with Novo Nordisk is very valuable as we seek to disseminate our Japan-origin innovation globally as early as possible.”
Marcus Schindler, chief scientific officer, EVP Research and Early Development at Novo Nordisk commented:
“Through this important collaboration with Heartseed, we aim to pioneer novel treatment solutions for people with cardiovascular disease. We gain access to an innovative clinical asset, underlying technology and deep expertise within the field of iPSC biology and cardiac cell transplantation, which can be combined with our knowledge and capabilities in stem cell biology and manufacturing. Novo Nordisk Stem Cell R&D is uniquely placed to accelerate the development of this potential therapy, and this exciting deal fits with our increased focus on cardiovascular disease which is the world’s leading cause of death.”
About the heart failure cell therapy HS-001
Allogeneic iPSC-derived highly purified ventricular cardiomyocyte spheroids are Heartseed’s main pipeline, HS-001. The retention rate and viability of cell transplants are increased by creating micro-tissue-like spheroids. Spheroids are implanted into the myocardial layer of the heart using a specific administration needle (SEEDPLANTER®) and guide adapter. The transplanted cardiomyocytes are predicted to increase cardiac output by electrically coupling with the patient’s myocardium, as well as secrete angiogenic factors to build new blood vessels surrounding the transplant site (neovascularisation). Japan’s Pharmaceutical and Medical Devices Agency has completed the analysis of the Clinical Study Application of a phase I/II clinical trial (LAPiS Study) examining the safety and effectiveness of HS-001 for the treatment of heart failure caused by ischemic heart disease in March 2021.
Heartseed Inc. was founded in 2015 to develop and commercialize cardiac remuscularization therapy developed by Professor Keiichi Fukuda and his group at the Department of Cardiology, Keio University, Tokyo, Japan. Heartseed has proprietary technologies throughout the entire manufacturing process of the cardiomyocyte-cell product, including purification, cell delivery and iPSC production. Heartseed was named “Healthcare Company of the Year 2020” by Healthcare Magazine and “Top 10 Startup in Japan” by Startup City and “Minister of Science and Technology Policy Award” at Japan Venture Awards 2021.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. The company’s purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. Novo Nordisk does so by pioneering scientific breakthroughs, expanding access to its medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,800 people in 80 countries and markets its products in around 170 countries.