In its decision of 24 March, the AMF Executive Committee fined AB Science € 1 million for breaching its obligation to publish inside information regarding the high probability of receiving a negative opinion on an application for a marketing authorization for a medicinal product.
He also imposed on Mr. Olivier Hermine, co-founder of AB Science, and Mr. Grégory Pépin, one of its shareholders, fined 50,000 and 500,000 euros for transmitting and using the same information, as well as other inside information. also in connection with an application for a marketing authorization for another medicinal product. The Commission also exonerated another co-founder of the company, accused of using one of these inside information.
The Sanctions Committee received breaches of two inside information related to the high probability that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency would issue a negative opinion on the market for applications for marketing authorization from masitinib, AB Science. star product, in the treatment of mastocytosis for the first information and amyotrophic lateral sclerosis (ALS) for the second.
With regard to the first information, the Commission considered that it had acquired a precise character not from 7 March 2017, the date used in the allegations, but from 7 April 2017, the date on which AB Science had received the report. of the CHMP speakers who analyzed the latest answers provided by the company to their questions, and who concluded that the application for marketing authorization should be rejected. The Commission considered that this information had only been made public on 17 May 2017 and that it was likely to have a significant effect on the price of AB Science’s share. On this point, he first noted that financial analysts presented AB Science’s research on the treatment of mastocytosis as one of the key data to consider when evaluating the price of stocks, the communication of ‘AB Science with investors subscribing to this perspective. He went on to point out that the clinical study on the treatment of mastocytosis was then one of AB Science’s most advanced clinical studies, the aim of which was to obtain its first marketing authorization in human medicine. The Commission concluded that this information was privileged from April 7, 2017, and remained so until May 17, 2017, the date of its publication by AB Science.
With regard to the breaches of this information, the Commission considered, first, that AB Science had not shown that it had a legitimate interest in postponing its publication and that it had therefore failed to fulfill its obligation to publish as soon as possible. . He then considered that Mr. Hermine, co-founder of AB Science, co-chair of its scientific committee and director of its clinical strategy, had breached its obligation to refrain from disclosing this inside information, considering that it had been aware of it. in the performance of his duties, and had subsequently passed it on to Mr. Pépin, a shareholder in the company. He considered that the latter had breached its obligation to refrain from using this inside information, which is characterized by both self-employed and mutual fund transactions. The Commission, for its part, exonerated another co-founder of AB Science, accused of using this information before the date on which it had acquired its privileged status.
Regarding the second information, regarding the high probability that the CHMP will issue a negative opinion on the use of masitinib in the treatment of ALS, the Committee maintained its precise nature from 21 March 2018, date of the oral meeting. explanation with the CHMP, which is the last contradictory phase of the procedure for reviewing a marketing authorization application, and at the end of which the CHMP members unanimously adopted a negative voting trend. The Commission also noted that this information had only been made public on 19 April 2018. It also noted that the ALS-related clinical study was AB Science’s most advanced program at the time and that then the company did not have any marketing authorization for human medicine. In addition, a year earlier, the price of AB Science had dropped when the rejection of the application for marketing authorization for masitinib in the treatment of mastocytosis was announced. Therefore, this information is likely to have a significant influence on the course of AB science. For the Commission, it was privileged from March 21, 2018.
Based on a set of serious, accurate and consistent evidence, based on the existence of a plausible transmission circuit resulting from various exchanges between Mr. Hermine and Mr. Pepin, the appropriateness of the controversial interventions of Mr. Pépin, who began a few moments after the end of one of his telephone conversations, the atypical nature of his speeches, and the lack of convincing justification to explain them, the Commission considered that the breaches of the obligations to abstain from disclosure and use of inside information alleged to MM. Hermine and Pépin were characterized.
This decision can be appealed.