Publication date: 22/09/2017
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces it has signed an exclusive, royalty-bearing license agreement with one of Japan’s leading industrial companies, Asahi Kasei Corporation (Tokyo: 3407). The license agreement covers the development and commercialisation of Bone Therapeutics’ autologous bone cell therapy product, PREOB®, in Japan.
Under the terms of the agreement, Asahi Kasei will obtain exclusive rights to develop, register and commercialise PREOB® for the treatment of osteonecrosis of the hip with the potential for other orthopaedic and bone applications in Japan. Bone Therapeutics will share its patented proprietary manufacturing expertise for the expansion and differentiation of stem cells into bone-forming cells in preparation for continued clinical development by Asahi Kasei in Japan. In addition, Bone Therapeutics has also granted Asahi Kasei an option to negotiate an exclusive license for the development and commercialization of PREOB® in Korea, China and Taiwan.
Bone Therapeutics will receive an upfront payment of €1.7 million from Asahi Kasei and is eligible to receive up to €7.5 million from development and commercial milestone payments, as well as tiered royalties based on annual net sales of PREOB® in Japan.
Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented:
“This agreement is an important additional validator of our innovative regenerative technology in the field of orthopaedics and bone diseases and of its global, commercial potential. With its world-class research and development capabilities, its strong network and specific knowledge of the Japanese market, we believe Asahi Kasei is the ideal partner to develop and commercialize PREOB® in Japan and bring this promising therapy to patients in Asia. We look forward to working with the team at Asahi Kasei as we bring our platform closer towards commercialisation.”
Hideki Kobori, President & Representative Director of Asahi Kasei Corporation, said:
“We are delighted to be collaborating with Bone Therapeutics to develop and commercialize its unique autologous cell therapy product, PREOB®, in Japan. The field of orthopaedics is a major area of focus for Asahi Kasei and we believe PREOB® has the potential to add significant value to our current pipeline and has the potential to be a first-in-class treatment for patients suffering from debilitating bone conditions, such as osteonecrosis of the hip.”
PREOB® is Bone Therapeutics’ cell-based medicinal product derived from autologous (derived from the patient) bone marrow mesenchymal stem cells. The active part of the product comprises human autologous osteoblastic cells, which are specialized cells that have the ability to restore a healthy bone environment and promote bone regeneration. Local implantation of these biologically active osteoblasts at the bone defect site is intended to mimic the natural process of bone formation and repair.
Today, PREOB® is being developed as a first in-line conservative treatment for early stages of osteonecrosis of the hip. Based on the promising results from an earlier Phase IIB study, which have shown clinically and radiologically relevant benefits, PREOB® is currently being evaluated in a pivotal Phase III study in Europe in the treatment of this debilitating disease. Key interim efficacy results are expected in Q3 2018 and could lead to a premature termination of patient recruitment.
About Asahi Kasei Corporation
Asahi Kasei, headquartered in Tokyo, Japan, is one of Japan’s leading industrial companies, with a combined revenue of €15 billion and more than 33,000 employees, and a global leader in a diverse range of markets, including pharmaceuticals, medical devices and bioprocess consumables. Through its pharmaceutical core operating company, Asahi Kasei Pharma, the group is growing as a specialty pharmaceutical firm with a global presence by focusing on the development of new world-class drugs in the fields of orthopaedics, circulatory, urology, the immune system, and the central nervous system. For more information, please visit the company’s website at www.asahi-kasei.co.jp/asahi/en/.
About Bone Therapeutics
Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.
Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.
Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis.
Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.