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Treatment of rare skin disorder by Amryt gets EUR 20 m backing from European Investment Bank’s first ever pharma loan in Ireland Lead asset, Episalvan, now fully funded for pivotal Phase 3 study

Sufferers of rare skin disorders will benefit from new treatment being developed by Amryt Pharma to be supported by the European Investment Bank’s first direct backing for pharmaceutical investment by an Irish company. The agreement for the new EUR 20 million loan was formally agreed at the European Investment Bank’s Luxembourg headquarters by Joe Wiley, Chief Executive Officer of Amryt and Andrew McDowell, European Investment Bank Vice President.
Epidermolysis Bullosa is a rare and inherited skin disorder that causes the skin to become very fragile and for which there is currently no available treatment. Amryt Pharma 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 Epidermolysis Bullosa.  The Epidermolysis Bullosa treatment market in the US and Europe is estimated to be worth around EUR1.5 billion a year.
Amryt, the clinical-stage specialty pharmaceutical company focused on best-in-class treatments for rare and orphan diseases, has entered into a €20m facility agreement with the EIB on highly attractive terms for the Company. The Facility is significant because it provides non-dilutive funding that secures the Company’s near and mid-term funding needs for its lead product, Episalvan. It also provides the funding required to progress the Company’s orphan designated acromegaly drug compound, AP 102, through pre-clinical development and into the clinic.
“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.” said Andrew McDowell, European Investment Bank Vice President.
As previously announced, the Company has submitted its protocol for the pivotal phase 3 study for Episalvan, to demonstrate its efficacy and safety for the treatment of Epidermolysis Bullosa (“EB”).  First patient enrolment is set to commence in the first quarter of 2017 with top-line data anticipated in mid 2018 and commercial launch expected in 2019.
Key terms of the Facility
The Facility has a five-year term from drawdown and the associated repayment schedule is expected to present a minimal cash burden to the Company during the term, ahead of repayment. 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, commented that “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.
We remain very excited about the potential of Episalvan to treat Epidermolysis Bullosa, a rare and distressing hereditary skin disorder that affects about 500,000 patients worldwide. Currently, there is no available treatment for EB and we believe that Episalvan, a topical gel, has a compelling clinical profile. EB is one of the many rare diseases where sufferers currently have no treatment options – there are 7,000 known rare diseases but only circa 550 orphan drugs have been approved to date. Having now fully funded our Episalvan program, we will look for further opportunities to fill the incredibly high unmet need in the orphan drugs market.”
Over the last decade the European Investment Bank has provided more than EUR 130 billion to support innovation investment across Europe.
The new European Investment Bank loan to Amryt is supported by the InnovFin – EU Finance for Innovators’ Midcap Growth Finance programme, with the financial backing of the European Union under Horizon 2020 Financial Instruments.