November 30, 2021 -- Bone Therapeutics and Link Health Pharma have signed a nonbinding agreement for the global rights regarding the development, manufacturing, and commercialization of ALLOB, Bone Therapeutics' off-the-shelf, human, allogeneic bone cell therapy derived from bone marrow mesenchymal stromal cells. The two companies plan to sign a binding license agreement by the end of 2021.
Depending on the final agreement, Bone Therapeutics will receive reimbursement for R&D costs, commercial milestone payments of up to 60 million euros (nearly $68 million), and up to 25% in tiered royalties of net sales.
The new partnership is separate and independent from the existing license agreement that was signed on October 5, 2020, between Bone Therapeutics, Link Health, and Shenzhen Pregene Biopharma for the rights to develop, manufacture, and commercialize ALLOB by Link Health in Hong Kong, Macau, Singapore, Taiwan, Thailand, and South Korea and by Pregene in China.
Bone Therapeutics will continue to work closely with Link Health and Pregene on all development activities. Link Health is responsible for all future development, including the ongoing ALLOB-TF2 clinical trial, as well as costs related to development, scale up, and manufacturing of the product.
The ALLOB-TF2 clinical trial is a randomized, double-blind, placebo-controlled phase IIb study in patients with high-risk tibial fractures to assess ALLOB's ability to accelerate fracture healing alongside standard-of-care stabilization surgery at three months and to assess the prevention of late-stage complications.
ALLOB is also being evaluated for uses in other orthopedic areas, including spinal fusion, osteotomy, and oral maxillofacial applications.
Link Health is a biopharmaceutical company based in Guangzhou, southern China. It conducts clinical development, business, and marketing in China, several Asian territories, and the Netherlands.
Bone Therapeutics is a biotech company based in Gosselies, Belgium, that is focused on the development of products to address unmet needs in orthopedics and related fields.