Amryt Pharma PLC EUR20m Facility with European Investment Bank (7654Q)

TIDMAMYT

RNS Number : 7654Q

Amryt Pharma PLC

02 December 2016

AIM: AMYT

ESM: AYP

Amryt Pharma plc

("Amryt" or the "Company")

EUR20m facility agreed with European Investment Bank ("EIB")

Lead asset, Episalvan, now fully funded

for pivotal Phase 3 study

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 EUR20m 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 EUR10 million available immediately and two further tranches of EUR5 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 EUR20m 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."

Andrew McDowell, European Investment Bank Vice President, commented:

"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."

Enquiries:

 
 Amryt Pharma plc                 C/o KTZ Communications 
 Joe Wiley, CEO 
  Rory Nealon, CFO/COO 
 
                                  +44 (0) 20 
 Shore Capital                     7408 4090 
 Nomad and Joint Broker 
 Bidhi Bhoma, Edward Mansfield 
 
                                  +353 (1) 679 
 Davy                              6363 
 ESM Adviser and Joint 
  Broker 
 John Frain, Anthony Farrell 
 
                                  +44 (0) 20 
 Stifel                            7710 7600 
 Joint Broker 
 Jonathan Senior, Ben 
  Maddison 
 
                                  +44 (0) 20 
 KTZ Communications                3178 6378 
 Katie Tzouliadis, Emma 
  Pearson 
 

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 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.

This information is provided by RNS

The company news service from the London Stock Exchange

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December 02, 2016 02:01 ET (07:01 GMT)