The rise of Bone Therapeutics06/10/2020

The Walloon biotech company specialising in the development of innovative cell therapies in orthopaedics and other serious pathologies soared on the stock market on Monday morning following the announcement of a licensing agreement in Asia. Under the terms of this agreement, the Chinese companies Link Health and Pregene will be able to develop and market the ALLOB technology developed by Bone Therapeutics in China and several Southeast Asian countries, resulting in the Charleroi-based biotech company receiving up to €55 million.

The announcement of this agreement has visibly reassured the markets, as the biotech's stock soared by more than 32 % when markets opened on Monday morning and closed up 23.32 % at €2.40.

Link Health Pharma and the Shenzhen Pregene Biopharma Company have been granted the exclusive licence to manufacture, clinically develop and market ALLOB, Bone Therapeutics' ready-to-use allogeneic bone cell therapy platform in China (including Hong Kong and Macau), Taiwan, Singapore, South Korea and Thailand.

Under the terms of the agreement, in addition to royalties on sales, Bone Therapeutics may receive up to €55 million in milestone payments, €10 million of which are expected within the next 24 months. Furthermore, the Walloon biotech retains the development and marketing rights to ALLOB in all other geographical areas outside those covered by this agreement. Accordingly, Bone Therapeutics will continue to develop and market ALLOB in the US and Europe and, more broadly, to develop new innovative cell therapy products.

"As well as expanding our geographic reach, this collaboration between Bone Therapeutics, Link Health and Pregene demonstrates the strong commercial potential of ALLOB," said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics.

"This collaboration and the securing of a licensing agreement for Bone Therapeutics' ALLOB platform mean that we can now add another major asset to our product portfolio. ALLOB has already demonstrated its ability to reduce recovery time and stimulate bone growth in a wide range of bone conditions and has had a major impact on patients' quality of life," commented Yan Song, PhD, CEO of Link Health.

The ready-to-use allogeneic cell therapy product, ALLOB, consists of human bone-forming cells derived from cultured mesenchymal stem cells, themselves derived from the bone marrow of healthy adult donors. In preclinical studies, ALLOB showed a 50% reduction in healing time in delayed healing fractures, as well as good tolerance levels.

The product has also showed signs of efficacy in two Phase IIa studies conducted in two different indications. The randomised, placebo-controlled, double-blind Phase IIb clinical Bone Therapeutics trial in patients with difficult tibia fractures has received regulatory approval in six of the seven planned European countries.

The first patient is due to be recruited before the end of the year.

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