• Financing to boost late-stage development of novel therapy to treat life-threatening diseases, such as Sepsis Associated Acute Kidney Injury.
  • EUR 24 million transaction supported by the European Commission under the InnovFin EU-finance for innovators programme.

The European Investment Bank and AM-Pharma B.V. have signed a EUR 24m financing agreement to accelerate the development of the innovative Dutch clinical stage biopharmaceutical company’s recombinant alkaline phosphatase enzyme (recAP), used to treat acute kidney injury (AKI). The financing will support a multi-national ‘phase III trial’ of recAP in 1,400 patients with sepsis-associated-acute kidney injury (SA-AKI). It also allows the Company to fund the steps required to submit market authorization applications following the trial’s completion. The EIB’s financing is supported under the “Infectious Diseases Finance Facility” (IDFF) of the InnovFin programme under the EU’s research and innovation programme Horizon 2020.

Sepsis is the body’s response to infections, which can lead to tissue damage, organ failure and ultimately, death. Acute Kidney Injury (AKI) is one of the most frequent organ failures in septic patients, with high mortality rates. The product that AM-Pharma is developing has the potential to transform the treatment prospects for patients with Sepsis Associated Acute Kidney Injury (SA-AKI). Through the support of IDFF, the EIB can provide stable long-term funding with a flexible repayment and interest structure, limiting the cash outflow from the company and thereby enabling it to focus on investing in innovation and growth.

At AM-Pharma, we are undergoing a critical Phase III clinical trial for our recAP therapy in Sepsis Associated Acute Kidney Injury. The funding from the EIB, supported under the InnovFin program, will enable us to fully focus on investing in recAP as a life-saving treatment. We’d like to thank the EIB for its support for our clinical programme.” said Erik van den Berg, CEO of AM-Pharma.

Mariya Gabriel, European Commissioner for Innovation, Research, Culture, Education and Youth, said: “Through Horizon 2020, we invest in better health for all. Sepsis Associated Acute Kidney Injury is a very serious condition with no approved treatment. This deal is a good example of how EU-funded research and innovation can protect health and save lives.”

The EIB’s support for “recAP” under the InnovFin programme ensures that Europe fosters AM-Pharma’s growth and creates new highly skilled jobs in the EU.” said Ambroise Fayolle, EIB Vice-President in charge of Innovation. “Through this project, and all its R&D activities, AM-Pharma will be part of the competitive search and generation of new knowledge in Europe, in areas that are of the utmost importance to the health of its citizens. The Bank is glad that it can support the quest for enhanced understanding and treatment of infectious diseases and induced pathologies.”

Background Information:

Under Horizon 2020, the EU research and innovation framework programme for 2014-20, the ‘Infectious Diseases Finance Facility (IDFF)’ provides financial products ranging from standard debt to equity-type financing for amounts typically between EUR 7.5 million and EUR 75 million, to innovative players active in developing innovative vaccines, drugs, medical and diagnostic devices or novel research infrastructures for combatting infectious diseases. Project costs may include clinical trial costs, set-up of commercialization such as market access, development of prototypes or industrial roll out of novel equipment, pre-clinical R&D costs and working capital requirement. This facility is delivered directly by the EIB, which so far has made available EUR 241 million under the InnovFin IDFF.

AM-Pharma Holding BV is a late clinical-stage biopharmaceutical company with a mission to become the leader in the treatment for Acute Kidney Injury (AKI). The Company was founded in 2001 and is based in Utrecht, The Netherlands.