The European Investment Bank will lend up to €20 million to PAION AG, a German pharmaceutical company specialised in anaesthesia and sedation drugs.
Luxembourg, 28 June 2019
Fresh funds will support European development programme of remimazolam drug
EIB financing provided under Investment Plan for Europe, or Juncker Plan
The
European Investment Bank (EIB)
will lend up to €20 million 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/anaesthetic drug candidate for use in procedural sedation, general anaesthesia and intensive care unit (ICU) sedation.
The EU bank’s loan will support PAION’s research and development 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 anaesthesia.
In 2018, PAION started an EU Phase III clinical trial for the induction and maintenance of general anaesthesia. 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 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.
About European Investment Bank
The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.
About the Investment Plan for Europe
The
Investment Plan for Europe
, known as the Juncker Plan, is one of the European Commission’s top priorities. It focuses on boosting investment to generate jobs and growth by making smarter use of new and existing financial resources, removing obstacles to investment, and providing visibility and technical assistance to investment projects.
The European Fund for Strategic Investments (EFSI) is the main pillar of the Juncker Plan and provides first loss guarantees, enabling the EIB to invest in more projects that often come with greater risks. EFSI has already yielded tangible results. The
projects and agreements
approved for financing under EFSI are expected to mobilise almost €410bn in investments and support 952 000 SMEs in the 28 Member States. More information on the results of the Investment Plan for Europe is available
here
.
About PAION
PAION AG is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs for out-patient and hospital-based sedation, anesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic drug candidate for which PAION has completed the clinical development for use in procedural sedation in the U.S. and its local licensee Cosmo Pharmaceuticals submitted a New Drug Application in April 2019. In Japan, licensee Mundipharma filed for market approval for remimazolam in general anesthesia in December 2018. In China, licensee Yichang Humanwell filed for market approval for remimazolam in procedural sedation in November 2018.
In Europe, PAION is currently focused on the development of remimazolam for general anesthesia, but is also evaluating the possibility of submitting a Marketing Authorization Application in procedural sedation based on the U.S. development program.
Development of remimazolam for intensive care unit (ICU) sedation is part of the longer-term life-cycle plan for remimazolam.
PAION’s vision is to become an acknowledged “PAIONeer” in sedation and anesthesia. PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
Press contact
EIB: Christof Roche,
c.roche@eib.org, tel.: +352 4379 89013, mobile: +32 479 65 05 88 Website: – Press Office: +352 4379 21000 – press@eib.org
PAION:
Ralf Penner Vice President Investor Relations/Public Relations, phone: +49 2414453-152, E-mail: r.penner@paion.com Website:
Disclaimer:
This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG’s management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company’s assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.