(AOF) – Theranexus is up 8.65% to 1.85 euros after announcing with the Beyond Batten Disease Foundation (BBDF) that it has obtained the positive opinion of the European Medicines Agency (EMA) on the design of the pivotal phase 3 study of their drug candidate Batten-1 in Batten disease. This biopharmaceutical company specializing in the treatment of rare neurological diseases specifies that the EMA’s response is aligned with the terms of the agreement obtained from the Food and Drug Administration in early May 2023 on the design and efficacy criteria of the phase 3 study of Batten-1.
“We are very pleased to have obtained the agreement of the EMA, after that of the FDA, on the design and criteria of the pivotal phase 3 study of our drug candidate Batten-1, a study which will be carried out in Europe and the United States”, explains Mathieu Charvériat, CEO of Theranexus. “We are actively preparing the launch of the study by the end of 2023, aiming for registration in these territories and then the first sales of the product as early as 2027”.
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Loss of speed in European research
European research is losing ground to American and Chinese research. In twenty years, Europe’s share has fallen from 41% to 31% in global R&D. China’s share jumped from 1% to 8%. As for the United States, which supplanted Europe, in 2001 it devoted only 2 billion euros per year more than Europe to R&D, whereas now this gap has reached 25 billion! Some experts accuse the European authorities of not having deployed effective policies. The financing of pharmaceutical research should therefore have been better targeted via the “Horizon 2020” programme. France only comes in eighteenth position in European funding despite the quality of its research. Conversely, the United States concentrates funding on Boston and a few centers of excellence.