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.
Background information:
About EIB
The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.
About Amryt Pharma plc - see www.amrytpharma.com
Amryt Pharma is a specialty pharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare or ‘orphan’ diseases. The Company is building a diversified portfolio of commercially attractive, best-in-class, proprietary new drugs to help address some of these rare and debilitating illnesses for which there are currently no available treatments.
Amryt’s lead product, Episalvan, received marketing approval for the treatment of partial-thickness wounds from the European Commission in January 2016. Amryt intends to develop Episalvan as a new treatment for Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children for which there is currently no treatment. Amryt is currently planning a phase 3 study of Episalvan in EB, which has been granted US and EU orphan drug designation. The market opportunity for EB is estimated to be circa US$1.5 billion.
Amryt’s earlier stage product AP102 is focused on developing novel, next generation somatostatin analogue (“SSA”) peptide medicines for patients with rare neuroendocrine diseases, where there is a high unmet medical need, including acromegaly and Cushing’s disease. AP102 was recently granted orphan designation in the US in acromegaly by the FDA. The Company joined AIM and Dublin’s ESM in April 2016 following the reverse takeover of Fastnet Equity PLC.
About InnovFin
Under Horizon 2020, the EU research programme for 2014-20, the European Commission and the European Investment Bank Group (EIB and EIF) have launched a new generation of financial instruments and advisory services in 2014 to help innovative firms access finance more easily. Until 2020, “InnovFin – EU Finance for Innovators” offers a range of tailored products which will make available more than EUR 24bn of financing support for research and innovation (R&I) by small, medium-sized and large companies and the promoters of research infrastructures. This finance is expected to support up to EUR 48bn of final R&I investments.
Backed by funds set aside under Horizon 2020 and by the EIB Group, InnovFin financial products support R&I activities, which by their nature are riskier and harder to assess than traditional investments, and therefore often face difficulties in accessing finance. All are demand-driven instruments, with no prior allocations between sectors, countries or regions. Firms and other entities located in EU Member States and Horizon 2020 Associated Countries will be eligible as final beneficiaries.
