Bone Therapeutics and Link Health sign a non-binding term sheet for
the global rights of ALLOB
REGULATED INFORMATION
Link Health to be granted global rights for
development, manufacturing and commercialization of ALLOB
Bone Therapeutics to receive R&D cost
reimbursement, commercial milestone payments of up to €60 million
in total and tiered royalties on net sales of up to 25% upon
completion of final agreement
The two parties will immediately commence the
drafting of a binding License Agreement
Gosselies,
Belgium, 29 November 2021, 7am
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.” said Yan
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.
About ALLOB
ALLOB is Bone Therapeutics’ off-the-shelf
allogeneic cell therapy platform consisting of human allogeneic
bone-forming cells derived from cultured bone marrow mesenchymal
stromal cells (MSC) from healthy adult donors. To address critical
factors for the development and commercialization of cell therapy
products, Bone Therapeutics has established a proprietary,
optimized production process that improves consistency,
scalability, cost effectiveness and ease of use of ALLOB. This
optimized production process significantly increases the production
yield, generating thousands of doses per bone marrow donation.
Additionally, the final ALLOB product is cryopreserved, enabling
easy shipment and the capability to be stored at the point of care
for easy clinical use. The process will therefore substantially
improve product quality, reduce overall production costs, simplify
supply chain logistics, increase patient accessibility and
facilitate global commercialization. The Company has implemented
the optimized production process to produce clinical batches for
the ongoing Phase IIb clinical trial in patients with
difficult-to-heal tibial fractures.
About Link Health Pharma Co.,
Ltd
Link Health is a leading Chinese pharmaceutical
company based in Guangzhou, Southern China. Link Health has a
well-established team with solid track records in Licensing and
local development of innovative medicinal products in China and
Asia-Pacific. By its fully controlled subsidiary BioBone BV, Link
Health has created a pipeline including 8 assets for global
development in orthopedics and pain management. Link Health has its
own research laboratories and core technology to lead
drug-materials combo research and lead in the disease modifying
novel therapy for orthopedic complicated diseases. Link Health has
full team to execute registration, clinical development, business
and marketing in China, in several Asian territories and in
Netherlands in the Europe.
About Bone Therapeutics
Bone Therapeutics is a leading biotech company
focused on the development of innovative products to address high
unmet needs in orthopedics and other diseases. The Company has a
diversified portfolio of cell therapies at different stages ranging
from pre-clinical programs in immunomodulation to mid stage
clinical development for orthopedic conditions, targeting markets
with large unmet medical needs and limited innovation.
Bone Therapeutics’ core technology is based on
its cutting-edge allogeneic cell and gene therapy platform with
differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs)
which can be stored at the point of use in the hospital. Currently
in pre-clinical development, BT-20, the most recent product
candidate from this technology, targets inflammatory conditions,
while the leading investigational medicinal product, ALLOB,
represents a unique, proprietary approach to bone regeneration,
which turns undifferentiated stromal cells from healthy donors into
bone-forming cells. These cells are produced via the Bone
Therapeutics’ scalable manufacturing process. Following the CTA
approval by regulatory authorities in Europe, the Company has
initiated patient recruitment for the Phase IIb clinical trial with
ALLOB in patients with difficult tibial fractures, using its
optimized production process. ALLOB continues to be evaluated for
other orthopedic indications including spinal fusion, osteotomy,
maxillofacial and dental.
Bone Therapeutics’ cell therapy products are
manufactured to the highest GMP (Good Manufacturing Practices)
standards and are protected by a broad IP (Intellectual Property)
portfolio covering ten patent families as well as knowhow. The
Company is based in the BioPark in Gosselies, Belgium. Further
information is available at www.bonetherapeutics.com.
For further information, please
contact:
Bone Therapeutics SAMiguel
Forte, MD, PhD, Chief Executive OfficerLieve Creten, Chief
Financial Officer ad interimTel: +32 (0)71 12 10
00investorrelations@bonetherapeutics.com
For Belgian Media and Investor
Enquiries:BepublicCatherine HaquenneTel: +32
(0)497 75 63 56catherine@bepublic.be
International Media Enquiries:Image Box
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Media and Investor
Enquiries:NewCap Investor Relations &
Financial CommunicationsPierre Laurent, Louis-Victor
Delouvrier and Arthur RouilléTel: +33 (0)1 44 71 94
94bone@newcap.eu
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