Bone Therapeutics S.A., a biotechnology company located in Gosselies, Belgium, was accused by Belgium’s Financial Services and Markets Authority of failing to communicate an adverse event in a timely way. As a result, Bone Therapeutics agreed to pay a fine and enter into a settlement agreement.
It’s All About Timing. Interesting European Regulatory Story
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Bone Therapeutics is biologics company whose products address orthopedic and other disease treatments. In 2016, the company began to develop an “off-the-shelf, allogeneic cell therapy platform” brand named ALLOB.
Bone Therapeutics also developed PREOB. According to Bone Therapeutics, PREOB is “an autologous osteoblastic cell therapy product.” The company was developing PREOB for the treatment of osteoporosis (OP), non-union fractures (NU), and hip osteonecrosis (ON).
During that time, Bone Therapeutics encountered difficulties with product clinical development. Specifically, according to the company, management experienced a “lack of external partners, recruitment delays and failures of acceleration programs.” The difficulties, which Bone Therapeutics identified in February 2016 and December 2016, affected the commercial prospects for ALLOB-OP (ALLOB for the treatment of osteoporosis), PREOB-NU (PREOB for the treatment non-union fractures), and PREOB-ON (PREOB for the treatment of hip osteonecrosis). Bone Therapeutics stopped developing the products.
That, in turn, triggered the Financial Services and Markets Authority to begin a market abuse investigation. The investigation found that “Bone Therapeutic did not clearly communicate this information until the press releases announcing the discontinuation of the clinical development of these three programs respectively in January 2017, December 2017 and November 2018.”
In July 2021, the Financial Services and Markets Authority Executive Committee accepted a settlement from Bone Therapeutics in the amount of €500,000. Bone Therapeutics does not admit any guilt in the matter and the settlement does not affect its future programs.
In addition to the settlement, Bone Therapeutics has made changes to its board and management. The company has also “taken a number of initiatives to strengthen its market communication procedures.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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