- Fresh funds will support European development program of remimazolam drug
- EIB financing provided under Investment Plan for Europe, or Juncker Plan
The European Investment Bank (EIB) will lend up to EUR 20m to PAION AG, a German pharmaceutical company specialised in anaesthesia and sedation drugs. The Aachen-based company is currently developing ‘remimazolam’, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic drug candidate for use in procedural sedation, general anaesthesia and intensive care unit (ICU) sedation.
The EU bank’s loan will support PAION’s R&D investment programme to bring remimazolam to market. The loan is backed by a guarantee from the European Fund for Strategic Investments (EFSI), the heart of the Investment Plan for Europe – the Juncker Plan – under which the EIB and the European Commission are working together as strategic partners and the EIB’s financing operations are boosting the competitiveness of the European economy.
EIB Vice-President Ambroise Fayolle, who is responsible for operations in Germany and for EFSI said: “Innovative and R&D-intensive companies are key ingredients for ensuring sustainable growth and creating high-value jobs. For the EIB, the EU Bank, this is a top priority. Our cooperation with PAION, supported by the Juncker-Plan, is an excellent example how Europe can boost innovation and competitiveness.”
European Commission Vice-President Jyrki Katainen, responsible for Jobs, Growth, Investment and Competitiveness, said: “The purpose of the European Fund for Strategic Investments is to allow the EIB to finance even more innovative companies, support their research and development activities and hopefully enable them to bring their products to market. This is precisely what this financing to PAION aims to do, with European patients the main beneficiaries.”
Dr. Wolfgang Söhngen, CEO of PAION AG, commented. “With three remimazolam submissions currently in the approval process, we have reached very important milestones with our employees, cooperation partners and licensees. Therefore, it is a great vote of confidence from the EIB and the European Fund for Strategic Investments to include us in the Juncker plan to fund innovative R&D companies and promising product candidates. It enables us to perform remimazolam’s European development program not only in general anaesthesia but also in procedural sedation. We very much look forward to bringing remimazolam to doctors and patients as quickly as possible.”
PAION performed a broad clinical programme and remimazolam demonstrated efficacy and safety with around 2,400 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile. In the last months, three of PAION’s licensees submitted for market approval in China and in the U.S. for procedural sedation and in Japan for general anesthesia.
In 2018, PAION started an EU Phase III clinical trial for the induction and maintenance of general anesthesia. Based on scientific advice obtained from the European Medicines Agency (EMA), PAION expects that a positive Phase III trial in combination with previously completed clinical studies in Europe and Japan should be sufficient to file for market approval for general anesthesia. The goal of the trial is non-inferiority of remimazolam and to show better hemodynamic stability than the current standard of care propofol. Patient recruitment is ongoing and data are expected in 2020. Additionally, PAION is currently evaluating the possibility of submitting a Marketing Authorization Application (MAA) for remimazolam in procedural sedation with the EMA based on the completed U.S. development program still in 2019.
MC Services AG served as financial advisor to PAION for the transaction.