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A loan from the European Investment Bank will give BiondVax resources for Phase III trials and a manufacturing facility for its universal flu vaccine.
The European Investment Bank (EIB) and BiondVax Pharmaceuticals, developer of the universal flu vaccine candidate M-001, have entered into a €20 million (approximately $22 million) loan agreement, the company announced in a June 19, 2017 press release. The loan will give BiondVax the resources to launch Phase III trials and set-up a mid-sized commercial manufacturing plant.
BiondVax’s M-001 vaccine candidate, consisting of nine widely conserved flu epitopes, is designed to protect against current and future, seasonal and pandemic flu strains. Clinical and pre-clinical trials have shown that M-001 is safe and immunogenic and that it has the capacity to enhance and broaden coverage of current flu vaccines. M-001 has also shown potential to improve upon current seasonal flu vaccines and potential to serve as an immediate effective response to new flu pandemic strains. The vaccine candidate has been tested in a Phase IIb clinical trial in collaboration with UNISEC, which is funded by the European Union under the 7th Framework Programme for Research and Technological Development.
“A healthier population is a major priority for the EU, and preventing and treating the flu is becoming more and more important with the ageing of the European population. As the virus rapidly changes, we need to develop new ways to combat the disease. This €20 million loan agreement will help develop a more universal vaccine, effective in preventing a range of different types of flu,” said Carlos Moedas, European commissioner for Research, Science, and Innovation, in the press release.
The finance contract between BiondVax and the EIB has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe. kENUP chairman Holm Keller noted in the press release, “The State of Israel’s substantive and smart investments in fundamental research are an important catalyst for establishing globally leading industries in Europe. We are proud to be a liaison between the relevant European institutions and Israel’s leading research institutions.”
The EIB-BiondVax non-dilutive financing agreement will be structured as a zero-percent fixed interest loan, available for up to 36 months with a variable remuneration based on royalties of net sales of M-001 following commercialization. Funds will be advanced in three tranches. The tranches are available up to 12, 24, and 36 months following the date of the agreement and are dependent on achievement of certain specified milestones, with the ultimate milestone including authorization to launch a Phase III trial. The tranches are repayable five years after each drawdown. BiondVax retains the option to repay the loan and repurchase the royalties at any time.