On March 31, 2016 Following its announcement on 22 February 2016, Fastnet reported that it published an Admission Document detailing its conditional agreement to acquire the entire issued share capital of Amryt Pharmaceuticals DAC ("Amryt") for a consideration of £29.6 million to be satisfied by the issue of the Consideration Shares, (the "Acquisition"). The Company is also proposing to raise £10.0 million (before expenses) through a conditional placing of 41,673,402 New Ordinary Shares at the placing price of 24 pence per new Ordinary Share (equivalent to 3 pence per share before the Capital Reorganisation) and the issue of Placing Warrants on the basis of one Placing Warrant for every two Placing Shares subscribed.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Joe Wiley, Proposed CEO of Amryt Pharma plc, commented:
"Today’s announcement is an important step towards realising the Company’s vision of building a specialty pharmaceutical company focused on best in class treatments for Orphan Diseases. We are focused on building a portfolio of differentiated medicines, in therapeutic areas where there is large unmet medical need and which offer significant commercial potential.
"Importantly, the £10 million in new funds will enable us to accelerate the development of Episalvan as a treatment for epidermolysis bullosa, a rare, debilitating, genetic skin disorder and orphan condition that typically affects young children and for which there is currently no approved therapy. We believe the recent European approval of Episalvan for the treatment of Partial Thickness Wounds in adults and a successfully completed phase IIa trial in epidermolysis bullosa itself meaningfully de-risks the probability of approval in this indication."
The Acquisition constitutes a reverse takeover in accordance with Rule 14 of the AIM Rules for Companies and Rule 14 of the ESM Rules for Companies. Fastnet is seeking Shareholder approval for the Proposals at the General Meeting. Subject to approval of the Proposals, the Company will change its name to Amryt Pharma plc and begin trading under the new tickers "AMYT" (AIM) and "AYP" (ESM).
Amryt was incorporated in August 2015 as a platform to acquire, build, develop and subsequently monetise a pipeline of patent protected, commercially attractive, proprietary drug candidates targeting best in class performance chosen to meet the Orphan Drug Designation criteria. Where appropriate, the Enlarged Group will commercialise the drugs it successfully develops through its own salesforce. In line with this strategy, Amryt has entered into agreements, conditional, inter alia, on Admission to acquire both Birken AG ("Birken") and SomPharmaceuticals ("Som"). Birken is a revenue generating pharmaceutical development and manufacturing company based in Germany that has developed a recently approved drug for partial thickness wounds and promising potential orphan drug candidate for epidermolysis bullosa ("EB"). Som is a Swiss/US based biopharmaceutical company focused on developing novel somatostatin analogue peptide medicines for patients with rare neuroendocrine diseases with high unmet need, principally focused on additional orphan drug candidates to address acromegaly and Cushing’s disease.
The New Board intends to use the net proceeds of the Placing to initiate a Phase III clinical trial of Episalvan with a view to obtaining a label extension for Episalvan to include approval for the treatment of EB in Europe and seek regulatory approval in the US.
Highlights
The New Board believes that following completion of the Acquisition, the Enlarged Group will have the following key strengths:
An approved drug – Birken’s lead drug, Episalvan, is a potential treatment for the orphan condition epidermolysis bullosa ("EB"), already approved in Europe as a treatment in adults for accelerated healing of partial thickness wounds ("PTWs") following three successful phase III studies.
· EB is a rare and distressing genetic skin disorder typically affecting young children, where there is currently no approved treatment.
o EB leads to mechanical fragility of skin, characterised by the presence of recurrent PTWs and blisters as a result of mutations in structural proteins.
· Episalvan has been awarded Orphan Drug Designation ("ODD") in the US and EU for EB.
· The drug has successfully completed a Phase IIa study in ten EB patients (data from 12 wounds).
o Episalvan demonstrated significantly faster healing over 14 days of treatment for recent wounds and 28 days of treatment for chronic wounds compared with standard of care therapy.
· The global EB market is estimated to be worth approximately US$1.5 billion per annum.
· The drug received formal marketing approval from the European Commission on 14 January 2016 for the treatment in adults for accelerated healing of PTWs.
o PTWs involve loss of the epidermis and basement layers of skin extending into the dermis layer below.
o Episalvan effectively represents a new category of advanced wound care. management in PTWs and is targeting a market which the New Board assesses to be worth in excess of €150 million.
· The Company intends to seek approval for Episalvan in EB in Europe and the US and will embark on a phase III study in H2 2016 in this indication.
A highly experienced management team – The New Board and senior management is comprised of experienced industry participants including:
· Harry Stratford, Chairman, is the founder of Shire plc, now a FTSE 100 biopharmaceutical company, and ProStrakan Group plc
· Joseph Wiley, CEO, has over 20 years’ experience in healthcare investment and pharmaceutical operational roles
· Rory Nealon, CFO and COO, has spent the last 13 years as both CFO and then COO of Trinity Biotech PLC, a NASDAQ listed company
· Michele Bellandi, CCO, is the former Head of Commercial Europe for Shire AG International and has held senior marketing roles at Serono and Eli Lilly
· Ray Stafford, a Non-Executive Director, previously EVP of Global Marketing for Forest Laboratories which was listed on NYSE prior to being acquired for approximately US$28 billion
· James Culverwell, a Non-Executive Director, previously head of European pharmaceutical equity research at Merrill Lynch in London until 2005.
An attractive potential opportunity in Acromegaly/Cushing’s disease
· The Company estimates the Acromegaly and Cushing’s disease markets to be in excess of US$1.15 billion per annum in aggregate
A business model that offers an attractive risk/reward profile
· Recent approval of Episalvan together with Birken’s existing Imlan product line should appreciably lower the risk profile of the Company, whereas the opportunity in the EB and Acromegaly/Cushing’s disease markets offers significant upside potential
· The risks associated with obtaining regulatory approval in EB have been reduced following the European approval of Episalvan in PTWs in adults in Europe
Orphan Drug market represents a significant opportunity
· Worldwide orphan drug sales are forecast to total US$176bn (CAGR 2014 – 2020:+10.5%)
· Orphan Drugs are set to be 19.1% of worldwide prescription sales by 2020
· Currently there are 7,000 orphan diseases with 1 in 10 of the world’s population suffering from an orphan disease
Use of proceeds from the transaction include:
· Satisfying certain of the milestone payments now due as payable under the Birken SPA
· Fund the clinical trial costs associated with seeking approval of Epislavan as a treatment for EB
· Satisfy certain liabilities of Som under the Som SPAs; and
· For general working capital purposes for the Enlarged Group.
Unless the context otherwise requires, defined terms shall have the meaning ascribed to them in the Admission Document. The Admission Document is available on the Company’s website www.fastnetequity.com