Amryt, the clinical-stage specialty pharmaceutical company focused on fighting rare and orphan diseases, has raised a five-year €20m loan with the European Investment Bank (EIB), saying it was on highly attractive terms for the company.
Amryt said on Friday that the loan is significant because it secures fundings for its skin topical gel Episalvan, and for developing and testing the orphan designated acromegaly drug compound, AP 102.
As previously announced, Amryt has made first steps for the phase 3 study for Episalvan, to test it against a rare and hereditary skin disorder Epidermolysis Bullosa (EB), which affects half a million people worldwide. The Phase 3 clinical trial in EB is expected to be initiated in Q1 of 2017 with top-line data to be available in mid-2018 and commercial launch expected in 2019.
Amryt believes that Episalvan is a good candidate to be the first treatment for EB, as there is currently no available treatment for it. There are 7,000 known rare diseases but only circa 550 orphan drugs have been approved to date.
US and Europe market $1.5 billion
Amryt recently secured a US patent for the use of Episalvan in the treatment of EB, having previously obtained a patent in Europe for the treatment of all partial thickness wounds, including those from EB. The EB market in the US and Europe is estimated to be worth about $1.5 billion yearly.
About Amryt’s loan
The Facility is split into three tranches, with €10 million available immediately and two further tranches of €5 million available upon the achievement of certain milestones in relation to Episalvan.
The Facility has an interest rate of 3% over the Euro Interbank Offered Rate to be paid periodically, with a further 10% accruing and payable in a bullet together with the outstanding principal amount on expiry of the Facility.
Joe Wiley, CEO, said: “This €20m facility with the European Investment Bank is a significant milestone for Amryt and represents a material endorsement of our potential from a leading European investment body. We are delighted to have secured non-dilutive funding for the pivotal Phase 3 clinical trial of Episalvan, our lead asset. The facility also enables us to progress our acromegaly drug compound, AP 102, as well as consider other licensing opportunities as part of our ongoing strategy to acquire, develop and commercialise products for rare and orphan diseases.”
Andrew McDowell, European Investment Bank Vice President, said: “Continued investment in innovation is crucial to improve lives and build on European strengths to develop world-leading pharmaceutical products. The European Investment Bank is pleased to support innovation and development of new treatment of painful skin disorders by Amryt Pharma. 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.”