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Novo Nordisk enters agreement with Heartseed

Marcus Schindler

Heartseed Inc. and Novo Nordisk A/S have entered into an exclusive worldwide collaboration and license agreement for development, manufacturing and commercialization of Heartseed’s HS-001.

HS-001 is an investigational cell therapy using purified cardiomyocytes derived from induced pluripotent stem cells (iPSC), which is currently under development by Heartseed for the treatment of heart failure.

“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,” says Marcus Schindler, chief scientific officer, EVP Research and Early Development at Novo Nordisk. “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.”

Phase 1/2 clinical trial

Heartseed is planning to initiate a phase 1/2 clinical trial in Japan (LAPiS Study) in the second half of 2021 evaluating the safety and efficacy of HS-001 for the treatment of heart failure caused by ischemic heart disease. Japan’s Pharmaceutical and Medical Devices Agency has approved Heartseed’s Clinical Trial Application to carry out the clinical trial.

Heartseed is eligible to receive payments totalling up to 598 million USD

Under the terms of the agreement, Novo Nordisk gains exclusive rights to develop, manufacture and commercialise HS-001 worldwide except in Japan. Heartseed will maintain the rights to solely develop HS-001 in Japan and Novo Nordisk has the rights to co-commercialise the product in Japan with Heartseed with 50/50 profit and cost sharing.

Heartseed is eligible to receive payments totalling up to 598 million US dollars including 55 million dollars in upfront and near-term milestone payments. Heartseed is also eligible to receive tiered high single-digit to low double-digit royalties of annual net sales outside of Japan.

“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,” said Keiichi Fukuda, CEO of Heartseed. “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.”

Photo of Marcus Schindler: Novo Nordisk