Amryt Pharma has secured a €20 million ($21 million) loan from the European Investment Bank (EIB) to fund a pivotal trial of its lead candidate in epidermolysis bullosa. The specialty pharma, which is chaired by Shire founder Harry Stratford, is set to start the phase 3 clinical trial early next year.
EIB is making €10 million available to Amryt immediately. Amryt will get the rest in two €5 million tranches when it hits certain milestones. The size and structure of the facility is designed to ensure Amryt has the cash to take its lead candidate Episalvan through to a phase 3 data drop in mid-2018. And have enough left over to hustle acromegaly candidate AP 102 through preclinical development and into human trials.
Amryt picked up Episalvan and AP 102 in a pair of acquisitions earlier this year. The takeovers were part of a flurry of activity that outlined the strategy being overseen by Stratford and managed by CEO Joseph Wiley, formerly of Sofinnova Ventures and Astellas Pharma. With Shire’s former European commercial head Michele Bellandi running that side of Amryt’s business, the team is set up on paper to buy in assets, push them to the regulatory finish line and turn them into profitable franchises.
Episalvan will serve as a proving ground for the model. Birken, one of the company’s Amryt bought in March, has already won approval for the betulin-based product as a way to speed healing of partial thickness wounds. Amryt thinks this gives it a shot of also being effective in epidermolysis bullosa, a group of rare, inherited conditions characterized by such wounds. And, as a rare, genetic disorder, epidermolysis bullosa could prove to be a profitable indication.
Amryt joins a growing list of European drug developers to turn to EIB for money to support their R&D activities. Over the past 18 months, EIB has provided €100 million to support Alzheimer’s research at Grifols, €50 million to bankroll Ebola and immunotherapy programs at Bavarian Nordic and €130 million to enable Imperial Innovations and Malin to invest in startups. EIB plans to continue with the direct support approach it took to Amryt.
“This represents the EIB's first-ever direct support for investment by an Irish pharma company and I am pleased to confirm the EIB's intention to increase support for private sector innovation in Ireland in the years ahead,” EIB VP Andrew McDowell said in a statement.
With EIB securing the financial future of Episalvan and AP 102, Amryt is stepping up the search for other assets that fit with its development and business model.