Novo Nordisk and Heartseed Announce $598 Million Global Collaboration for iPSC-Derived Cell Therapy HS-001 Targeting Heart Failure

On June 1, Novo Nordisk and Heartseed announced that they have entered into a global exclusive collaboration and license agreement for the HS-001 stem cell therapy, with a total transaction value of up to $598 million.

Under the agreement, Novo Nordisk will pay a $55 million upfront payment, followed by near-term milestone payments, and high-single-digit to low-double-digit royalties on annual net sales outside Japan. Novo Nordisk will obtain exclusive global rights to develop, manufacture, and commercialize HS-001 outside Japan, along with the right to co-commercialize the product in Japan with Heartseed on a 50/50 profit- and cost-sharing basis. Heartseed will retain exclusive rights to develop HS-001 in Japan.

HS-001 is an experimental cell therapy developed by Heartseed, Inc., utilizing purified cardiomyocytes derived from induced pluripotent stem cells (iPSCs) for the treatment of heart failure. iPSC therapy involves first reprogramming a patient's own cells into iPSCs, followed by inducing their differentiation into specific cell types for therapeutic application.

In the second half of 2021, Heartseed plans to initiate a Phase I/II clinical trial (the LAPiS study) in Japan to evaluate the safety and efficacy of HS-001 for the treatment of heart failure caused by ischemic heart disease. Currently, the PMDA has approved Heartseed, Inc.'s clinical trial application.

Heartseed Chief Executive Officer Keiichi Fukuda said: “We are delighted to have a company like Novo Nordisk, with its expertise and resources, as a partner for the development and commercialization of HS-001, and we are honored that Novo Nordisk recognizes the innovation and high potential of this technology. We believe that our collaboration with Novo Nordisk is highly valuable and will enable the early global commercialization of this innovative Japanese technology.”

Marcus Schindler, Executive Vice President and Head of Research & Early Development and Chief Scientific Officer at Novo Nordisk, stated, “This collaboration with Heartseed will open new treatment options for patients with cardiovascular disease. The innovative clinical asset we are acquiring—featuring foundational technology and deep expertise in iPSC biology and cardiac cell transplantation—can be integrated with our knowledge and capabilities in stem cell biology and manufacturing. Novo Nordisk is uniquely positioned to accelerate the development of this potential therapy, and this significant transaction aligns with our focus on cardiovascular disease, a leading cause of death.” (Bioon.com)