Bone Therapeutics SA
Bone Therapeutics SA
11/29/2021 | Press release | Distributed by Public on 11/29/2021 00:02
11/29/21 - Bone Therapeutics and Link Health sign a non-binding term sheet for the global rights of ALLOB
Gosselies, Belgium, 29 November 2021, 7:00 am CET - BONE THERAPEUTICS
(Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, and Link Health Pharma Co., Ltd ("Link Health"), today announce the signing of a non-binding term sheet for the global rights for ALLOB, Bone Therapeutics' allogeneic bone cell therapy. Subject to the fulfillment of customary condition precedents, Bone Therapeutics and Link Health aim to complete the final agreement and to fully execute it by the end of 2021. This new partnership is separate and independent from the existing license agreement signed on October 5, 2020, for the rights to develop, manufacture and commercialize ALLOB in China for Pregene, and in Hong Kong, Macau, Singapore, Taiwan, Thailand and South Korea for Link Health. Bone Therapeutics will continue to work closely in partnership with Link Health and Pregene on all development activities. Link Health will be responsible for all future development, including the ongoing ALLOB TF2 Phase IIb trial and costs related to development, process development (scale up) and manufacturing of ALLOB. The deal will have no immediate direct cash impact, other than support of all development costs, since no upfront payment is foreseen, however, Bone Therapeutics will receive commercial milestone payments of up to €60 million in total and tiered royalties on net sales of up to 25%. "The existing collaboration between Bone Therapeutics, Link Health and Pregene for the development of ALLOB in Asia has progressed swiftly and fully in line with the anticipated schedule. Bone Therapeutics expanding its collaboration with Link Health will allow for the development and potential availability of ALLOB globally for the benefit of patients with high orthopedic unmet medical needs," said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. "This deal now enables Bone Therapeutics to concentrate resources and focus more fully on its iMSC platform. We are now utilizing our extensive cell therapy expertise to develop cell and gene therapy products that have strong anti-inflammatory and immunomodulatory properties, for the treatment of acute life-threatening diseases."
"Link Health has now broadened its therapeutic portfolio to address orthopedic unmet medical needs, aiming to be a global leader in this area. We have already several assets in clinical trial and next generation drug-material combo will also part of our efforts. For ALLOB, we believe that the evidence that Bone Therapeutics has already generated supports its potential clinical value for patients in various indications including spinal fusion and difficult fractures." saidYan Song, PhD, Chief Executive Officer of Link Health. "Our extended collaboration with Bone Therapeutics will further support the global development of ALLOB. This will enable us to progress in delivering novel disease modifying solution for unmet medical needs for orthopedic patients worldwide." ALLOB is currently being evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures. This study will assess and compare against placebo, in association with standard of care stabilization surgery, the potential for ALLOB to accelerate fracture healing after 3-months follow-up and prevent late-stage complications. ALLOB will be applied by a single percutaneous injection 24-96 hours post-definitive reduction surgery in patients with fresh tibial fractures at risk of delayed or non-union.
(Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, and Link Health Pharma Co., Ltd ("Link Health"), today announce the signing of a non-binding term sheet for the global rights for ALLOB, Bone Therapeutics' allogeneic bone cell therapy. Subject to the fulfillment of customary condition precedents, Bone Therapeutics and Link Health aim to complete the final agreement and to fully execute it by the end of 2021. This new partnership is separate and independent from the existing license agreement signed on October 5, 2020, for the rights to develop, manufacture and commercialize ALLOB in China for Pregene, and in Hong Kong, Macau, Singapore, Taiwan, Thailand and South Korea for Link Health. Bone Therapeutics will continue to work closely in partnership with Link Health and Pregene on all development activities. Link Health will be responsible for all future development, including the ongoing ALLOB TF2 Phase IIb trial and costs related to development, process development (scale up) and manufacturing of ALLOB. The deal will have no immediate direct cash impact, other than support of all development costs, since no upfront payment is foreseen, however, Bone Therapeutics will receive commercial milestone payments of up to €60 million in total and tiered royalties on net sales of up to 25%. "The existing collaboration between Bone Therapeutics, Link Health and Pregene for the development of ALLOB in Asia has progressed swiftly and fully in line with the anticipated schedule. Bone Therapeutics expanding its collaboration with Link Health will allow for the development and potential availability of ALLOB globally for the benefit of patients with high orthopedic unmet medical needs," said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. "This deal now enables Bone Therapeutics to concentrate resources and focus more fully on its iMSC platform. We are now utilizing our extensive cell therapy expertise to develop cell and gene therapy products that have strong anti-inflammatory and immunomodulatory properties, for the treatment of acute life-threatening diseases."
"Link Health has now broadened its therapeutic portfolio to address orthopedic unmet medical needs, aiming to be a global leader in this area. We have already several assets in clinical trial and next generation drug-material combo will also part of our efforts. For ALLOB, we believe that the evidence that Bone Therapeutics has already generated supports its potential clinical value for patients in various indications including spinal fusion and difficult fractures." saidYan Song, PhD, Chief Executive Officer of Link Health. "Our extended collaboration with Bone Therapeutics will further support the global development of ALLOB. This will enable us to progress in delivering novel disease modifying solution for unmet medical needs for orthopedic patients worldwide." ALLOB is currently being evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures. This study will assess and compare against placebo, in association with standard of care stabilization surgery, the potential for ALLOB to accelerate fracture healing after 3-months follow-up and prevent late-stage complications. ALLOB will be applied by a single percutaneous injection 24-96 hours post-definitive reduction surgery in patients with fresh tibial fractures at risk of delayed or non-union.