rns non-dilutive finding2 Dec 2016 07:42
Amryt, the clinical-stage specialty pharmaceutical company focused on best-in-class treatments for rare and orphan diseases, is pleased to announce that it has entered into a €20m facility agreement ("Facility") 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.
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"). The Phase 3 clinical trial in EB is expected to be initiated in Q1 of 2017 with top-line data anticipated to be available in mid-2018 and commercial launch expected in 2019.
EB is a rare and inherited skin disorder that causes the skin to become very fragile and for which there is currently no available treatment. The Company 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 c. US$1.5 billion per annum.
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:
"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 c