TIDMFAST
RNS Number : 6263T
Fastnet Equity PLC
31 March 2016
Fastnet Equity plc
("Fastnet" or the "Company")
31 March 2016
Proposed Acquisition of Amryt Pharmaceuticals Designated
Activity Company
Approval of a waiver of obligations under Rule 9 of the City
Code
Capital Reorganisation
Placing of 41,673,402 New Ordinary Shares at 24 pence
per New Ordinary Share and issue of Placing Warrants
Change of name to Amryt Pharma plc
Changes to the Articles of Association
Readmission of the Enlarged Group to trading on AIM and ESM
Notice of General Meeting
Creating a specialty pharmaceutical company focused on best in
class drugs in a US$176bn orphan drug market, with a lead product
addressing a $1.5bn market opportunity
Following its announcement on 22 February 2016, Fastnet (AIM:
FAST, ESM: FOI) today publishes an Admission Document detailing its
conditional agreement to acquire the entire issued share capital of
Amryt Pharmaceuticals DAC ("Amryt") for a consideration of GBP29.6
million to be satisfied by the issue of the Consideration Shares,
(the "Acquisition"). The Company is also proposing to raise GBP10.0
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.
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 GBP10 million in new funds will enable us to
accelerate the development of Episalvan(R) 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(R) 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(R) , 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 EUR150 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(R) 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
EXPECTED TIMETABLE OF PRINCIPAL EVENTS
Publication and despatch of the 31 March 2016
AIM Admission Document
Latest time and date for receipt noon on 14 April 2016
of Proxy Forms for the General Meeting
General Meeting noon on 18 April 2016
Record Date for the Capital Reorganisation close of business on
18 April 2016
Admission, completion of the Acquisition, 19 April 2016
the Placing and commencement of
dealings in New Ordinary Shares
CREST accounts credited 19 April 2016
Despatch of definitive share certificates 26 April 2016
in respect of New Ordinary Shares
(MORE TO FOLLOW) Dow Jones Newswires
March 31, 2016 02:01 ET (06:01 GMT)
STATISTICS RELATING TO THE PROPOSALS
Number of Existing Ordinary Shares 345,369,071
Number of New Ordinary Shares following the
Capital Reorganisation and prior to Admission 43,171,134
Number of Consideration Shares to be issued 123,495,096
Number of Placing Shares to be issued 41,673,402
Enlarged Share Capital following the Acquisition
and Placing 208,339,632
Number of existing warrants, Warrants and
Placing Warrants on Admission 23,401,463
Number of outstanding options on Admission 4,946,162
Fully diluted enlarged issued share capital* 236,687,257
Placing Price 24p
Gross proceeds of the Placing GBP10.0 million
Market capitalisation of the Company at the GBP50.0 million
Placing Price on Admission
Consideration Shares expressed as a percentage
of the Enlarged Share Capital 59.3%
Placing Shares expressed as a percentage of
the Enlarged Share Capital 20.0%
EPIC / TIDM AMYT
ESM Symbol AYP
ISIN following the Capital Reorganisation GB00BDD1LS57
SEDOL following the Capital Reorganisation BDD1LS5
Irish SEDOL following the Capital Reorganisation BDFYJ11
Exchange rate GBP:EUR 1.26
Exchange rate GBP:US$ 1.41
Exchange rate US$:EUR 0.89
*Note: On the basis that all existing warrants, Warrants,
Placing Warrants and outstanding options in issue on Admission are
exercised
Enquiries:
Fastnet Equity plc C/o FTI Consulting
Harry Stratford, Non-Executive
Director
+44 (0) 20 7408
Shore Capital 4090
Lead Manager, Nomad and Joint
Broker
Bidhi Bhoma, Edward Mansfield
Davy +353 (1) 679 6363
ESM Adviser and Joint Broker
John Frain, Anthony Farrell
+44 (0) 20 7710
Stifel 7600
Co-lead Manager
Jonathan Senior
+44 (0) 20 3727
FTI Consulting 1000
Simon Conway, Brett Pollard
1. Introduction
The Company announces that it has, in line with the Company's
Investing Policy adopted in August 2015, entered into a conditional
agreement with the Vendors to acquire the entire issued share
capital of Amryt for consideration of GBP29.6 million to be
satisfied by the issue of the Consideration Shares. In addition,
the Company is proposing to raise GBP10.0 million (before expenses)
through a conditional placing of 41,673,402 New Ordinary Shares at
the Placing Price and issue of Placing Warrants on the basis of one
Placing Warrant for every two Placing Shares subscribed. Further
details of the terms of the Acquisition and the Placing are set out
below under the headings "Principal Terms of the Acquisition" and
"Details of the Placing and the use of proceeds". 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.
Since incorporation, Amryt has received investment totaling EUR2.0
million to finance due diligence on potential target businesses and
as working capital. In line with its strategy, Amryt has entered
into agreements, conditional, inter alia, on Admission, to acquire
the entire issued share capital of each of Birken and Som under the
Birken SPA and Som SPAs respectively. Further information on Birken
and Som is set out below.
The Acquisition constitutes a reverse takeover under the AIM
Rules and ESM Rules. As a consequence, the Current Directors are
seeking Shareholder approval for the Proposals at the General
Meeting.
Irrevocable undertakings to vote in favour of the Resolutions
have been obtained from the Current Directors and certain
Shareholders.
Following Admission and the implementation of the Proposals, the
Vendors, taking into account their holdings in Existing Ordinary
Shares and following their participation in the Placing, will hold
interests in 139,579,380 New Ordinary Shares representing 67.0 per
cent. of the Enlarged Share Capital.
As part of the Proposals the Company intends to effect a Capital
Reorganisation whereby every Existing Ordinary Shares will be
consolidated into one New Ordinary Share and one Deferred
Share.
The nature of the Company's business will be transformed by the
Acquisition and, in order to reflect its new activities, it is
proposed to change the Company's name to Amryt Pharma plc.
The proposed Acquisition, Waiver and Placing are conditional,
inter alia, on the passing of the Resolutions and on Admission. It
is expected that Admission will become effective and dealings in
the Enlarged Share Capital will commence on AIM and ESM on 19 April
2016.
The Admission Document sets out the reasons for, and details of,
the Proposals, to explain why the Current Directors consider that
they are in the best interests of the Company and its Shareholders
as a whole, and to recommend that you vote in favour of the
Resolutions to be proposed at the General Meeting, notice of which
forms part of the Admission Document.
2. Background information on Amryt
Amryt was incorporated in August 2015 as a platform to acquire,
build, develop and subsequently monetise a commercially attractive
pipeline of drug candidates focused on treating orphan diseases.
The founders of Amryt believe the Orphan Drug sector is a growing
and commercially attractive segment of the pharmaceutical market as
described further below.
Amryt was founded by Cathal Friel, Joseph Wiley and Rory Nealon.
The New Board has extensive relevant healthcare and public company
experience. Joseph Wiley, the proposed CEO of the Enlarged Group,
has spent over 20 years in the healthcare sector, having initially
trained as a medical doctor and subsequently worked in both
healthcare investment and operational roles in the pharmaceutical
industry. Most recently, he opened and led the European office of
Sofinnova Ventures, a venture capital firm focused on the Life
Science sector, where he was responsible for identifying and
managing a number of investments in the biopharmaceutical space.
Prior to this, Joseph Wiley was a Medical Director with Astellas
where he liaised with the marketing team and was involved in the
launch of a number of specialty pharmaceutical products. He is
currently on the board of NASDAQ listed Innocoll AG, a specialty
biopharmaceutical company.
Rory Nealon, the proposed CFO/COO of the Enlarged Group, is a
qualified chartered accountant. He spent the last 13 years as both
CFO and then COO of Trinity Biotech plc, a NASDAQ listed company
that specialises in the development, manufacture and marketing of
diagnostic test kits. Rory Nealon is a member of the Institute of
Chartered Accountants in Ireland, the Institute of Taxation in
Ireland and the Institute of Corporate Treasurers in the UK. The
proposed New Board of the Enlarged Group also includes:
-- Harry Stratford, the founder of Shire plc, now a FTSE 100
specialty biopharmaceutical company, and ProStrakan Group plc;
-- Ray Stafford, previously Executive Vice President of Global
Marketing for Forest Laboratories which was listed on NYSE prior to
being acquired for approximately US$28 billion; and
-- James Culverwell, previously head of European pharmaceutical
equity research at Merrill Lynch in London until 2005.
Michele Bellandi, the proposed CCO of the Enlarged Group, most
recently was the Head of Commercial Europe for Shire AG
International where he was responsible the entire portfolio
representing over US$1.0 billion in revenues and over 600
employees. Before becoming Head of Europe he was General Manager of
France, Spain and Portugal for the rare disease business and
conducted multiple pricing negotiations of rare disease products.
Prior to joining Shire AG International he was Global Marketing
Director for the Neurology franchise at Serono (now Merck) where he
was responsible for Rebif and led the international launch
preparation of oral Cladribine. Previously he worked with Eli Lilly
as Cymbalta Global Marketing Manager and in several other global
marketing/sales management roles in the US, Italy and Japan.
Since incorporation Amryt has received EUR2.0 million in
investment (via the issue of B Ordinary Shares and Convertible
Debenture Securities) in order to complete the due diligence on
potential target businesses and as working capital. In line with
its strategy, Amryt has entered into agreements, conditional on
Admission, to acquire the entire issued share capital of each of
Birken and Som under the Birken SPA and Som SPAs respectively.
Following the Acquisition and Admission, each of Amryt, Birken and
Som will be wholly owned subsidiaries of the Company.
The New Board has a broad network of industry contacts. This is
exemplified by the experienced advisers engaged by Amryt while it
conducted its due diligence on Birken and Som, whose experience
includes Pfizer and the US FDA. These contacts should also provide
the Enlarged Group with access to additional prospective projects
going forward and ensure a continuous pipeline of opportunities and
further potential acquisitions, which will be assessed as they
arise.
3. Key Strengths of the Enlarged Group
The New Board believes that following completion of the
Acquisition, the Enlarged Group will have the following key
strengths:
(MORE TO FOLLOW) Dow Jones Newswires
March 31, 2016 02:01 ET (06:01 GMT)
-- An approved drug - Birken's lead drug, Episalvan, received
formal marketing approval from the European Commission on 14
January 2016.
-- Significant market upside in Epidermolysis Bullosa ("EB") -
Episalvan has successfully completed a Phase IIa study in ten EB
patients (data from 12 wounds), in which 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 New Board intends to pursue a label
extension for Episalvan in Europe and seek FDA approval for
Episalvan to treat EB in the US. The New Board estimates the global
EB market to be worth approximately US$1.5 billion per annum.
-- Highly experienced management team - the New Board and senior
management is comprised of experienced industry participants.
-- Attractive opportunity in Acromegaly/Cushing's disease - The
New Board estimates the Acromegaly and Cushing's disease markets to
be in excess of US$1.15 billion per annum in aggregate.
-- Business model offers an attractive risk/reward profile - the
recent approval of Episalvan together with Birken's existing Imlan
product line should appreciably lower the risk profile of the
Enlarged Group whereas the opportunity in the EB and
Acromegaly/Cushing's disease markets offers significant upside
potential. Furthermore, the risks associated with obtaining
regulatory approval in EB have been reduced following the recent
approval of Episalvan for the indication of partial thickness
wounds ("PTWs") in adults in Europe.
4. The Orphan Drug market
The New Board believes that the Orphan Drug market represents a
significant opportunity. Worldwide orphan drug sales are forecast
to total US$176bn (CAGR 2014 to 2020:+10.5%) with Orphan Drugs set
to be 19.1% of worldwide prescription sales by 2020. There are
currently 7,000 orphan diseases with 1 in 10 of the world's
population suffering from an orphan disease.
The US Orphan Drug Act of 1983, which was followed by
legislation implementing similar provisions in Europe, introduced a
number of financial incentives (including a period of market
exclusivity after approval, as well as R&D grants and tax
credits) to promote R&D in these typically under-served patient
populations. In the US an Orphan Drug benefits from seven years of
market exclusivity post approval for an orphan indication, while in
Europe an Orphan Drug benefits from a ten year period of
exclusivity. In addition to the financial incentives offered by
regulators, the market for Orphan Drugs often has a number of
attractive characteristics including:
-- free scientific advice and the waiver of regulatory fees,
with Phase III trials costing, on average, 50% less;
-- a limited range of alternative drugs enabling companies to
charge sustainable premium prices justified by the need to recoup
development costs; and
-- small patient populations that are generally accessed through
a limited number of channels enabling companies to use a specialty
pharma model to market their products.
From 1983 to 2014 the number of approved Orphan Drugs in the US
has increased from 38 to 373. The New Board believes this is a
consequence of the regulatory support and incentives in place. The
increase of approved Orphan Drugs is reflected in sales growth and
share of the prescription drug market.
5. Birken
Birken is a revenue generating pharmaceutical development and
manufacturing company based in Germany that has developed a new
therapy for the treatment of PTWs. Birken was founded by Dr. Armin
Scheffler and has to date received EUR54 million of investment from
the Software AG Stiftung Foundation, one of the largest charitable
foundations in Germany. Birken's operations are based in the state
of Baden Württemberg.
Birken's lead products are Episalvan (for the treatment of PTWs)
and Imlan (a derma cosmetic range) which both use a betulin rich
dry extract as their Active Pharmaceutical Ingredient ("API"). The
API is believed to act via promoting the migration of keratinocytes
(skin cells with wound repair capabilities) as well as transiently
increasing the level of pro inflammatory mediators (which also
promote healing). The nature of the API also enables formation of
the emulsion that is used in the commercial production of gels and
creams (without the need for additional emulsifiers or
surfactants). Episalvan has completed three positive Phase III
studies (two in the indication of split thickness skin graft donor
sites (219 patients) and one in the indication of burn wounds
(Grade 2a) (61 patients)) and one positive Phase IIa study (in the
indication of EB). On 19 November 2015 it was recommended for
approval by the CHMP of the EMA as a treatment for PTWs in adults.
Marketing approval was subsequently received from the European
Commission on 14 January 2016.
Episalvan has Orphan Drug Designation ("ODD") as a treatment for
the hereditary skin disorder Epidermolysis Bullosa in both Europe
and the US.
5.1. Active Pharmaceutical Ingredient ("API")
Birken has developed patented technology around the discovery
that its API can be readily and simply formulated as ointments
(oleogels) and creams (emulsions) without the need for excipients
or surfactants. Consequently, Birken's products have potential as
topical medications as its API can be utilised to formulate topical
products, with limited other ingredients. The API for both
Episalvan and Imlan is a highly characterised extract that
naturally occurs in birch bark. It is obtained through a patented
process in which birch bark (cortex) is processed under carefully
controlled conditions to yield a dry extract that contains c.80%
betulin and other structurally related compounds account for
another c.20% of the extract.
Betulin and the other components of the API have a number of
different pharmacological properties. They are known to have
antibacterial and antiinflammation effects to enhance keratinocyte
migration which are believed to be important features for the
acceleration of the healing process in PTWs.
Birken has important patent protection relating to the
extraction, formulation and most importantly the method of use of
betulin in the treatment of PTWs in Europe (including EB) and EB in
the USA.
5.2. Episalvan
Birken's lead product, which incorporates its API, is Episalvan,
a pharmaceutical product which has been shown in clinical studies
to accelerate wound healing in PTWs. Episalvan was recommended for
approval by the CHMP of the EMA in November 2015 and received
formal marketing approval from the European Commission on 14
January 2016.
The New Board believes that this product, when applied to
wounds, offers a significant number of practical benefits to
patients over other commercially available preparations containing
betulin. These include the fact that it is occlusive, providing an
air and watertight barrier for wounds, as well as additionally
providing a shield against potential microbial infection. In
addition, the New Board believes that the absence of excipients
reduces the propensity for skin irritation. The formulation also
forms a barrier between the wound and the dressings thereby
reducing the opportunity for dressings to stick to the wound. The
product is also stable for two years and requires no special
storage conditions.
Birken has conducted a number of clinical trials using Episalvan
that have demonstrated its efficacy and safety for the treatment of
PTWs. These include two Phase III studies for the treatment of
split thickness skin graft donor sites and a further Phase III
study for the treatment of second degree burns. Across all studies
Episalvan was both well tolerated and demonstrated accelerated
wound healing compared with standard of care therapy. In addition,
better long term outcomes across a number of parameters were
demonstrated with Episalvan.
In these studies Episalvan was rated superior over Standard of
Care by both physicians and patients as well as demonstrating
better long term outcomes.
Episalvan also has an excellent safety profile, with fewer
adverse events noted in the Episalvan treated side of the wounds (4
out of 280) against Standard of Care (18 out of 280).
5.3. Epidermolysis Bullosa
Birken's API also obtained ODD for the treatment of EB (a
hereditary skin disorder) from the EMA in February 2011 and the FDA
in July 2014.
EB is a rare multi gene chronic connective tissue disorder with
varying degrees of severity. EB leads to mechanical fragility of
skin, characterised by the presence of recurrent blisters and PTWs
as a result of mutations in structural proteins (e.g. keratins,
laminins, collagens and integrins). Diagnosis of EB normally occurs
in infancy and is classified into one of three major EB subtypes
(junctional, dystrophic or simplex) according to the layer of
cleavage within the skin. Although all forms of EB are considered
serious, the most severe can be disfiguring, excruciatingly painful
and lead to a number of complications including heightened risk of
sepsis, skin cancer, severe anaemia, heart failure, cardiomyopathy,
renal failure and can ultimately be fatal. To date, no drug has
been approved to treat this condition and there therefore remains a
substantial unmet need for drugs that can either cure or address
the symptoms.
(MORE TO FOLLOW) Dow Jones Newswires
March 31, 2016 02:01 ET (06:01 GMT)
Birken has demonstrated positive data in EB in a Phase IIa
clinical trial in 10 EB patients, with 12 wounds included. The
trial compared the intra individual efficacy and tolerability of
Episalvan versus non adhesive wound dressing alone in accelerating
the healing of skin lesions in patients. In summary, the study
demonstrated that Episalvan, combined with a non-adhesive wound
dressing, significantly accelerated the skin healing (8 of 8
decided cases; p=0.0078, binomial test) of wounds in inherited EB
compared to the use of non-adhesive wound dressing only (0 of 8
decided cases). Episalvan was also safe and well tolerated
throughout the trial. It is the New Board's intention to conduct a
Phase III confirmatory study in EB and thereafter seek marketing
approval for this indication in both the EU and US.
5.4. Imlan
Birken currently markets a range of derma cosmetics under the
Imlan brand which are also based on the API betulin and a betulin
emulsion. It comprises a range of skin care products to alleviate
symptoms associated with dry and irritated skin such as eczema,
psoriasis, atopic dermatitis, as well as treating damaged skin
barriers and allergy prone skins. The products may also relieve
itching and offer regenerative and anti-inflammatory properties.
The cream formulation is suitable for use by babies, children and
adults.
The Imlan range is currently sold exclusively through pharmacies
in Germany and generated sales of EUR879,821 in the financial year
ended 31 December 2014. As a derma cosmetic skin range, products
are regulated under food legislation, including cosmetic GMP with
registration at the BVL as well as requiring notification under the
Cosmetic Product Notification Portal. The New Board intends to
undertake a strategic review of the Imlan range in 2016, with
opportunities being explored to develop Imlan as a registered
medical device.
6. Som
SomPharmaceuticals S.A. is a Swiss based biopharmaceutical
company focused on developing novel somatostatin analogue ("SSA")
peptide medicines for patients with rare neuroendocrine diseases
with high unmet need. These disorders are caused by pituitary brain
tumours that either over produce growth hormone ("GH"), leading to
a disease known as Acromegaly or adrenocorticotropic hormone
("ACTH"), causing a disease known as Cushing's disease. Further
opportunities in other neuroendocrine tumours ("NETs") may also be
explored by the Enlarged Group in the future. First line treatment
for these patients is surgical removal of the tumour. However, in
many patients, surgery is non-curative and they have persistent
disease that requires an alternative pharmaceutical therapy such as
SSAs.
Acromegaly is a rare condition which affects approximately
62,000 people globally. Acromegaly has a distinct phenotype, with
sufferers having enlarged hands and feet and coarsened, enlarged
facial features. Joint paint and muscle fatigue can also be
observed and internally, organs such as the liver, heart, kidneys
and spleen can become enlarged. Acromegaly is additionally often
associated with a number of health problems if left untreated,
including Type 2 diabetes, colon polyposis, osteoarthritis,
cardiovascular disease, high blood pressure, uterine fibroids, and
sleep apnoea.
Cushing's disease is characterised by a variety of symptoms,
which can develop rapidly and be very severe, or present more
gradually and be milder in nature. Symptoms include weight gain and
fat deposition and skin changes such as thinning and bruising.
Musculoskeletal weakness in the hips, shoulders, arms and legs are
also common, as are mental health issues such as depression and
rapid mood swings.
Somtherapeutics Inc, the predecessor to Somtherapeutics Corp,
was founded by Dr Alan Harris in 1999 to develop the next
generation SSAs. Dr Harris was the clinician at Sandoz (now
Novartis) responsible for the successful development of the first
approved SSA, octreotide (Sandostatin(R)) for the treatment of
Acromegaly patients who have persistent disease post-surgery.
However, a large number of Acromegaly patients are resistant to
octreotide and require an alternative treatment. AP102 is a new SSA
developed by Som that targets not only the somatostatin receptor 2
("SSTR2"), but unlike octreotide, also receptor 5 ("SSTR5") which
is known to have an additional effect in reducing the effect of GH.
Novartis has developed a drug, pasireotide (Signifor(R)) that also
targets both SSTR2 and SSTR5 but the drug can also raise blood
glucose levels, which can contribute to the development of
diabetes.
Octreotide was developed to mimic the natural hormone
Somatostatin-14. As such it selectively binds to SSTR2 and is
comparable to Somatostatin-14. Subsequently, Pasireotide was
developed by Novartis as a next generation drug to bind to both
SSTR2 and SSTR5 as it is known that binding to both increases the
effect on growth hormone. Pasireotide is particularly effective at
binding to SSTR5 and does reduce growth hormone, but one of its
side effects is a potential increase of blood glucose levels and
hence the risk of contributing to the development of diabetes.
AP102 targets both SSTR2 and SSTR5 and the relative binding
affinity to SSTR2 and SSTR5 is comparable. Initial pre-clinical
studies show that AP102 does not cause an increase in blood glucose
levels.
7. Market opportunity
The Enlarged Group will utilise the net proceeds of the placing
to focus on the opportunity presented within the EB market as
described below. Subject to securing additional capital, which may
come from alternative sources such as licencing deals or venture
debt, the Enlarged Group would have the ability to exploit its
other assets, Episalvan in respect of PTWs which has been approved
for use in Europe and its preclinical assets focused on Acromegaly
and Cushing's disease, each as described below.
7.1. Epidermolysis Bullosa
There are estimated to be c.35,000 patients in Europe and
c.30,000 in the U.S. with EB (Source: The Dystrophic Epidermolysis
Bullosa Research Association (DEBRA) and Stanford School of
Medicine, "Epidermolysis Bullosa Clinic"). The subtypes of the EB
population are estimated to be distributed as follows: i)
junctional subtype, the most severe/rare, occurring at c.8%, ii)
dystrophic (c.31%), and iii) simplex (c.61%) as the most
common/least severe.
There remains a significant unmet need in this disease with, as
of yet, no specific approved therapy available. Four approaches
have shown early promise in the treatment of EB: gene therapy,
fibroblast therapy, bone marrow therapy and protein therapy (Soro
et al. 2015). However, all of these approaches are still many years
away from the market and would need to undergo extensive evaluation
in clinical trials over a number of years. Episalvan has been
developed as a treatment for the symptoms of EB and, as such, will
not be curative but rather accelerate wound healing in these
patients, with potential additional benefits on pain, itch and long
term outcomes.
In September 2015, Amicus acquired Scioderm Inc for US$842
million (subject to the achievement of certain clinical, regulatory
and commercial milestones). Scioderm also has a topical product
(Zorblisa) in development for the treatment of the symptoms of EB.
JP Morgan's analyst report (8 September 2015) on Amicus estimates
the market potential for Zorblisa to be more than US$1 billion in
annual peak sales and noted that Amicus is currently recruiting
patients in a Phase III study in Europe and the US. If Zorblisa is
approved, Episalvan would be the second product to market in this
indication. The New Board expects to begin a Phase III study in EB
in Q1 2017, with headline data available at the end of H1 2018. In
this context, the New Board intends to follow the predefined
regulatory pathway which has been agreed by Amicus with the FDA and
EMA. However, unlike in the Zorblisa Phase III study, it is
expected that Episalvan will not require daily dressing changes,
which is considered by the New Board to be a burden for EB patients
and which, the New Board believes, could be a significant
competitive advantage.
7.2. Treatment of Partial Thickness Wounds in Adults
The wound care management market is a diverse and highly complex
landscape. Products are divided into traditional solutions, such as
tissue adhesives, seals and glues, anti infective dressings, basic
wound care (tapes, dry dressings, cleansing), therapeutic devices
or more advanced wound care which typically include films, foam
dressings, collagens, alginates, hydrocolloids, hydrogels, super
absorbers and biologicals (artificial skin and skin substitutes).
To date, treatment for PTWs has been addressed by the use of over
the counter ("OTC") antiseptic hydrogels such as octenidine or
polihexanide, anti infectant creams such as Flammazine(R) (active
ingredient silversulfadiazine), traditional wound care solutions
(e.g. dressings and cleansings) or more advanced wound care
dressings (e.g. silicone wound contact layers).
Subject to securing finance in addition to the net proceeds of
the Placing, it is the New Board's intention that Episalvan will be
a first in class prescription pharmaceutical treatment with proven
efficacy initially targeting wounds in surgical specialities, such
as second degree burns and split thickness skin graft donor sites.
Currently, Episalvan has a clearly defined competitive advantage by
incorporating an innovative formulation with a novel API to treat
an unmet need for the wide range of wound types .
7.3. Size of the total addressable market for PTWs
The global wound care market is expected to grow at a CAGR of 5%
from EUR18.6 billion in 2011 to EUR25.7 billion in 2018 (Wound Care
Management Market to 2018, GBI Research, Global Business
Intelligence, GBIME0066MR, June 2012).
(MORE TO FOLLOW) Dow Jones Newswires
March 31, 2016 02:01 ET (06:01 GMT)
The size of the total addressable PTWs market for Episalvan in
Europe has been assessed by the New Board to approximate 700,000
patients in the top 10 European markets given the broad label that
has been approved by the EU (that is the treatment of PTWs in
adults). The New Board has made an assessment of the value of this
addressable market in Europe at over EUR150 million. This is based
on assumptions around uptake of Episalvan. However, as a first in
class pharmaceutical product to accelerate wound healing, Episalvan
effectively represents a new category of advanced wound care
management.
7.4. Acromegaly and Cushing's disease
Acromegaly is prevalent in an estimated 62,000 patients
worldwide. The current treatment of choice is surgery with
approximately 16,000 patients in Europe and the US requiring
ongoing therapy, usually with an SSA such as Octreotide or
Lanreotide. The New Board estimates the market for SSAs at c.US$2.0
billion, with c.US$650 million for Acromegaly alone in the US and
EU. The remainder of the market includes use of SSAs for Cushing's
disease and the treatment of other NETs.
Notably, no other therapy currently in development other than
AP102 is targeting both SSTR2 and SSTR5.
Up to 70% of patients are resistant to Octreotide therapy and
therefore require some additional treatment. Novartis developed
Pasireotide (Signifor) to address this unmet need as it targets
SSTR2 and SSTR5, which, when combined are known to have a more
profound effect on growth hormone secretion (Octreotide mainly
targets SSTR2). However, pasireotide may contribute to the
development of diabetes which may consequently limit its usage in
clinical practice. Som has developed an SSA (AP102) that targets
both SSTR2 and SSTR5 without raising glucose levels in a
pre-clinical model and therefore it has the potential to have a
better side effect profile than Pasireotide as it may not cause
diabetes. The Enlarged Group intends to take AP102 into the clinic
and conduct a proof of concept study in resistant Acromegaly and/or
Cushing's disease, subject to having raised sufficient capital to
do so. The New Board estimates the market opportunity (assuming
successful clinical trials and a commercial launch) for AP102 to be
c.US$650 million in Acromegaly and c.US$500 million in Cushing's
disease.
8. Strategy
The New Board's strategy is for the Enlarged Group to acquire,
build, develop and commercialise a portfolio of medicines focused
on rare and orphan diseases. Following the recent approval of
Episalvan in the EU, demonstrating the efficacy and safety in PTWs
healing, the New Board believes the risk of obtaining regulatory
approval for Episalvan to treat EB is reduced. Consequently, the
New Board intends to use the net proceeds of the Placing to
progress 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 approval in the US.
8.1. Episalvan in respect of EB
As a product designed for the treatment of the symptoms of an
orphan disease, developing Episalvan in EB will require significant
involvement of patient advocacy groups such as DEBRA. Amryt has
been in active discussions with DEBRA and it is the New Board's
intention to involve EB patients at every level of its Episalvan
development plan. This will include conducting patient advisory, as
well as scientific advisory panels to assist in the design of
clinical studies so that patient feedback becomes fully integrated
into the design of the Phase III clinical studies. In the US,
Amryt's management has already begun the process of engaging with
specialty pharmacy groups who can provide a full service offering
to patients to ensure that all patients will have equal access to
this new therapy. There are 15 specialist EB centres in the USA and
a small number in each individual European country. In light of the
limited number of centres and Key Opinion Leaders ("KOLs"), the New
Board believes that establishing a strong partnership coupled with
an individualised approach based on projects/studies that meet the
Company's and KOL's shared needs and interests will be pivotal to
the success of the Company. The Enlarged Group's management has
good experience of developing these networks. Given the limited
number of patients affected by rare diseases and the limited number
of specialist centres the New Board believes it should also be
possible for the Enlarged Group to conduct the development and
commercialisation of Episalvan alone without the need for a local
partner. In Europe, given the diverse nature of healthcare
structures in place in different countries, the New Board's
strategy is to engage with the local authorities on a country by
country basis to ensure prompt availability of Episalvan once
approved.
The expected launch preparation will be based on four key
phases:
i. Seed phase - understanding the specific market requirements and needs;
ii. Shaping phase - key centre identification coupled with
development of relationships with and lobbying of patient
organisations;
iii. Key market launch - organisation established and set up
alongside the implementation of an early access programme; and
iv. Expansion - establishing organisational networks in second
tier countries. The New Board intends to leverage off the sales
infrastructure established as a result of commercialising Episalvan
in relation to PTWs to address the EB market in Europe.
8.2. Episalvan in respect of PTWs
Subject to securing finance in addition to the net proceeds of
the Placing, the New Board intends to commercialise Episalvan in
Europe as a specialty pharmaceutical product possibly utilising an
outsourced sales force model. Specialty pharmaceuticals can benefit
from more focused sales and marketing strategies as products are
limited to a small numbers of centres with specialty expertise that
are often tertiary referral centres. This requires a small sales
force and should enable the Enlarged Group to commercialise
products without the need for a commercial partner and/or a large
sales team. The New Board's intention is that, once additional
funding is secured, the marketing function could be performed via
the well validated outsourcing model using one of a number of
providers. The advantage of this model is that it provides
flexibility to small companies without a sizable increase in fixed
overheads. Once launched sales and marketing will be managed
centrally by Michele Bellandi, the Enlarged Group's Chief
Commercial Officer. Even though the indication for Episalvan is
wide (the treatment of PTWs in adults), the intention is to target
speciality hospitals including burns units as they treat the
patients with the highest unmet medical need. National
reimbursement will not be sought in this indication, as Episalvan
will only be available through hospitals and specialist centres and
not be made generally available in the community. Instead, addition
to hospital formularies only will be sought, with reimbursement at
the hospital level where price points are accepted, making pricing
simpler. The New Board will seek to enter into licencing deals in
relation to Episalvan for territories outside of the US and EU and
has already commenced early stage discussions in this regard.
9. Principal Terms of the Acquisition
Under the terms of the Acquisition Agreement, the Company has
conditionally agreed to acquire Amryt from the Vendors, for a
consideration of GBP29.6 million to be satisfied by the issue of
123,495,096 New Ordinary Shares (being the Consideration Shares)
representing 59.3 per cent. of the Enlarged Share Capital.
The Acquisition Agreement is conditional, inter alia, on the
passing of the Resolutions, Admission and all of the conditions
under the Birken SPA and Som SPAs being satisfied other than
Admission.
9.1. Birken SPA
On 16 October 2015, Amryt entered into the Birken SPA.
Completion under the Birken SPA is conditional, amongst other
things, on Admission. Under the terms of the Birken SPA, the Birken
Sellers will receive:
-- an initial payment of EUR1 million, which was settled on signature of the Birken SPA;
-- EUR150,000 on completion;
-- milestone payments totalling up to EUR50 million payable on
achieving certain regulatory approvals and sales targets in
relation to Episalvan, of which EUR10 million is payable on
Admission following the receipt of approval of Episalvan by the
European Commission; and
-- royalties of 6-9% on sales of Episalvan for ten years from first commercial sale.
Additionally, the Birken Sellers will be issued with new
ordinary shares in Amryt representing 30.0 per cent. of the fully
diluted issued share capital of Amryt following the issue of:
i) consideration shares issued in Amryt in relation to the Som
SPAs referred to below; and
ii) shares issued in Amryt as a result of the conversion of the
B Ordinary Shares and CDS, but prior to any dilution resulting from
the transaction.
These new ordinary shares in Amryt will be acquired by the
Company pursuant to the Acquisition Agreement.
9.2. Som SPAs
Amryt entered into conditional SPAs to acquire each of
SomPharmaceuticals S.A and Somtherapeutics, Corp on 15 December
2015 and 4 December 2015 respectively (together the "Som SPAs").
Under the terms of the Som SPAs, Amryt will:
-- pay a maximum sum of US$100,000 in cash in respect of the
acquisition of Somtherapeutics, Corp (of which Alan Harris is the
sole shareholder) less Somtherapeutics, Corp's liabilities to the
extent that these are more than $150,000; and
-- pay US$4.15 million in respect of the acquisition of
SomPharmaceuticals S.A in new ordinary shares in Amryt, in respect
of which the Som Sellers will receive 12,277,102 Consideration
Shares under the Acquisition Agreement.
These new ordinary shares in Amryt issued pursuant to the Som
SPAs will be acquired by the Company pursuant to the Acquisition
Agreement.
10. Patent Portfolio
(MORE TO FOLLOW) Dow Jones Newswires
March 31, 2016 02:01 ET (06:01 GMT)
The New Board has a proactive approach to obtaining and
enhancing intellectual property rights for products which it
acquires. These rights will be enhanced by actively seeking ODD in
both Europe and the USA, which grants marketing exclusivity for the
Enlarged Group's products of ten years and seven years respectively
in those jurisdictions.
Significantly the Enlarged Group has obtained patent approval in
the EU for the use of Episalvan in the treatment of PTWs and has
recently obtained a method of use patent in the USA for the use of
the product in the treatment of EB.
11. Current trading and prospects
On 28 August 2015, the Company became an investing company under
the AIM Rules and ESM Rules. As at 30 September 2015, the Company
had a cash balance of US$15.5 million (EUR13.8 million), having
incurred a loss of US$1.5m during the period. Subsequent to the
financial period, on 17 December 2015, the Company demerged its oil
and gas subsidiaries into a separate company, Fastnet Hydrocarbons
Limited. The shares of Fastnet Hydrocarbons Limited are held in
trust for the benefit of shareholders on the register of the
Company as at the close of business on 16 December 2015.
The Company's cash balance was EUR12.1 million as at 29 March
2016, which is subsequent to the grant in December of an unsecured
four year term loan to Fastnet Hydrocarbons Limited of EUR660,000
to finance residual running of the legacy oil and gas assets. The
Company no longer has any on-going interest or further cost
exposure in respect of its historic oil and gas assets other than
this loan.
12. Details of the Placing and use of proceeds
The Company is proposing to raise approximately GBP10.0 million
(before expenses) by the issue of 41,673,402 New Ordinary Shares at
the Placing Price and granting the Placing Warrants on the basis of
one Placing Warrant for every two Placing Shares subscribed. The
Placing Shares will represent approximately 20.0 per cent. of the
Enlarged Share Capital. The Placing Shares will rank pari passu in
all respects with the New Ordinary Shares including the rights to
all dividend and other distributions declared, made or paid
following Admission and will be issued credited as fully paid. The
Placing has not been underwritten.
The EIS Placing Shares will be issued to investors seeking to
benefit from the tax advantages pursuant to the VCT and/or EIS
legislation. The Company has obtained advance assurance from HMRC
that the EIS Placing Shares will satisfy the requirements for tax
relief under EIS.
The Placing Warrants are exercisable on or before 31 December
2018.
The proceeds of the Placing together with the existing cash
balance within the Enlarged Group will be used to:
-- satisfy 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.
The Placing is conditional, inter alia, on:
-- the Placing Agreement becoming unconditional and not having
terminated in accordance with its terms prior to Admission; and
-- Admission occurring by no later than 19 April 2016 (or such
later date as Shore Capital, Davy and the Company may agree, being
no later than 21 April 2016).
13. Capital Reorganisation
The mid-market price of the Existing Ordinary Shares as at the
close of business on 30 March 2016 was 2.85p which is below their
nominal (or par) value of 3.8p per Existing Ordinary Share. The
issue of new shares by an English company at a price below their
nominal value is prohibited by English company law and accordingly
the ability of the Company to raise funds by way of the issue of
further equity is restricted.
Consequently, the Company is proposing the Capital
Reorganisation to reduce the nominal (or par) value of the Existing
Ordinary Shares substantially below their market price in order to
provide the Company with the ability to make future share issues
(including the proposed Placing). In addition, the share price
levels at which the Existing Ordinary Shares have recently traded
means that small absolute movements in the share price represent
large percentage movements resulting in share price volatility. The
Current Directors believe that the bid offer spread at these price
levels can be disproportionate and to the detriment of
Shareholders. Accordingly, the Current Directors have decided to
implement a share reorganisation such that:
each holding of every 8 or more Existing Ordinary Shares
will be consolidated into one New Ordinary Share and one
Deferred Share.
Holders of fewer than 8 Existing Ordinary Shares will not be
entitled to receive a New Ordinary Share or Deferred Share
following the Capital Reorganisation. Shareholders with a holding
in excess of 8 Existing Ordinary Shares, but which is not exactly
divisible by 8, will have their holding of New Ordinary Shares
rounded to the nearest whole number of New Ordinary Shares
following the Capital Reorganisation. Fractional entitlements,
whether arising from holdings of fewer or more than 8 Existing
Ordinary Shares, will be sold in the market and the proceeds will
be retained for the benefit of the Company.
The Existing Ordinary Shares have been admitted to CREST.
Application will be made for the New Ordinary Shares to be admitted
to CREST, all of which may then be held and transferred by means of
CREST. It is expected that the New Ordinary Shares arising as a
result of the Capital Reorganisation in respect of Existing
Ordinary Shares held in uncertificated form, i.e. in CREST, will be
credited to the relevant CREST accounts on 19 April 2016 and that
definitive share certificates in respect of the New Ordinary Shares
arising as a result of the Capital Reorganisation from Existing
Ordinary Shares held in certificated form will be despatched to
relevant Shareholders within 10 business days of completion of the
Capital Reorganisation. No temporary documents of title will be
issued. Share certificates in respect of Existing Ordinary Shares
will cease to be valid at close of business on 18 April 2016 and,
pending delivery of share certificates in respect of New Ordinary
Shares will be certified against the register. The Capital
Reorganisation Record Date is 18 April 2016.
As a consequence of the Capital Reorganisation, each
Shareholder's holding of New Ordinary Shares will (ignoring
fractional entitlements) immediately following the Capital
Reorganisation becoming effective be one eighth of the number of
Existing Ordinary Shares held by them on the Capital Reorganisation
Record Date. However, each Shareholder's proportionate interest in
the Company's issued ordinary share capital will remain unchanged
as a result of the Capital Reorganisation.
The Deferred Shares created will be effectively valueless as
they will not carry any rights to vote or dividend rights. In
addition, holders of Deferred Shares will only be entitled to a
payment on a return of capital or on a winding up of the Company
after each of the holders of New Ordinary Shares have received a
payment of GBP10,000,000 on each such share. The Deferred Shares
will not be listed or traded on the Official List, AIM, the ESM or
any other investment exchange and will not be transferable save
that upon the death of any holder of the Deferred Shares such
shares will be permitted to be transmitted under the terms of the
deceased Shareholder's will provided that the persons to whom they
are to be transmitted are a Privileged Relation of the deceased
Shareholder. No share certificates will be issued in respect of the
Deferred Shares, nor will CREST accounts of shareholders be
credited in respect of any entitlement to Deferred Shares. In
addition, the directors of the Company may arrange for the Company
to effect a re purchase of the Deferred Shares, for a consideration
of GBP0.01 (1 pence) for all of the Deferred Shares in issue,
subject to due compliance with all relevant legislation.
The ISIN of the New Ordinary Shares will be GB00BDD1LS57
following the Capital Reorganisation.
14. Related Party Transaction
Cathal Friel, Nonexecutive Chairman of Fastnet, is a director
and, taking into account the proposed issue of shares by Amryt to
the Birken Sellers and Som Sellers, 22.8 per cent. shareholder of
Amryt prior to the acquisition by Fastnet and associated Placing
(including for these purposes shares held by Raglan Capital, a
company of which he is a director and shareholder). The Acquisition
is consequently a related party transaction under Rule 13 of the
AIM Rules and ESM Rules. The Independent Directors consider, having
consulted with Shore Capital in respect of the AIM Rules and Davy
in respect of the ESM Rules, that the terms of the Acquisition are
fair and reasonable insofar as Shareholders are concerned.
15. Information on the Current Directors, Proposed Directors,
Advisory Board and Senior Management
The directors of the Company as at the date of this announcement
comprise Cathal Friel, Harry Stratford, Michael Nolan and Michael
Edelson. On Admission, Michael Nolan and Michael Edelson will
resign as non-executive directors with immediate effect and Cathal
Friel and Harry Stratford will continue as non-executive directors
of the Company, with Harry Stratford becoming Non-Executive
Chairman.
On Admission, Joseph Wiley and Rory Nealon will join the New
Board as CEO and CFO/COO respectively, while Ray Stafford and James
Culverwell will be appointed as non-executive directors. Harry
Stratford will become Non-Executive Chairman and Rory Nealon will
become company secretary on Admission.
(MORE TO FOLLOW) Dow Jones Newswires
March 31, 2016 02:01 ET (06:01 GMT)
Under the Acquisition Agreement, the Birken Sellers may within
three months of completion nominate in writing a person to be
appointed as a non-executive director of the Company and the
Company shall make such appointment promptly following receipt of
such nomination, subject always to SCC and Davy having undertaken
and being satisfied with relevant due diligence to confirm that the
person so nominated is suitable to be a director of a company whose
share capital is admitted to trading on AIM and ESM.
Brief summaries of the biographies of each of the Current
Directors and Proposed Directors are set out below:
15.1. Current Directors
Cathal Martin Friel (aged 51), Non-Executive Chairman and
proposed Non-executive Director
Mr Friel is managing director and one of the founders of Raglan
Road Capital Limited (which trades as Raglan Capital), a Dublin and
London based corporate finance and merchant banking group. Mr Friel
has over 25 years of managerial, entrepreneurial and corporate
finance experience, as well as successfully advising major UK and
Irish companies on domestic and international transactions.
He was previously one of the founding directors of Dublin based
Merrion Corporate Finance, where he helped build Merrion to
becoming one of Ireland's top three corporate finance and
stockbroking firms in less than 6 years, before successfully
selling it for approximately EUR100 million in 2006.
Harry Thomas Stratford (aged 68), Non-executive Director and
proposed Non-Executive Chairman
Mr Stratford has over 40 years' experience in the pharmaceutical
industry and has built two successful publicly listed
pharmaceutical companies. Mr Stratford founded Shire Plc in 1986
and was CEO for almost a decade. Shire Plc grew from humble
beginnings to be one of Europe's largest specialty pharmaceutical
companies and its stock is a constituent of the FTSE100 index. Mr
Stratford then went on to be founder, CEO and Executive Chairman of
Prostrakan Plc, another international specialty pharmaceutical
company, which was subsequently acquired by Kyowa Hakko Kirin of
Japan in 2011.
Mr Stratford holds a BSc. in Chemistry from the University of
London and was awarded an OBE in the 2007 New Year's Honours list
for his contribution to the Scottish Life Sciences Industry.
John Michael Edelson (aged 71), Non-executive Director
Mr Edelson has been on the board of Fastnet Equity Plc in a
non-executive capacity since he founded the Company (then called
Hamilton Partners plc). Since 1990 he has founded and been on the
board of many listed companies, mostly on AIM, including ASOS
(formerly Brindle plc), Magic Moments plc, Knutsford Group plc,
Mercury Recycling Group plc, Prestbury Group plc and Singer &
Friedlander AIM 3 VCT plc.
He has been a member of the board of Manchester United Football
Club Limited since 1982.
Michael Henry Nolan (aged 54), Non-executive Director
Mr Nolan was a founding director of Terra Energy Limited which
was acquired by Fastnet in 2012. Mr Nolan is a Chartered Accountant
having worked in practice with Deloitte in Dublin. From 2009 to
2012 Mr Nolan was a director and member of the management team of
Cove Energy Plc which was sold to PTTEP of Thailand in August 2012.
He acts as a non-executive director of Vancouver based, Rathdowney
Resources Limited, a private natural resource company operating in
Europe and supported by the Hunter Dickinson group and listed on
TSXV. He is also a director of AIM companies, Tiger Resource
Finance plc and Orogen Gold plc. He acted as chief executive
officer of AIM listed, mining company, Minmet Plc from 1999 to
2007. He also serves on the board of several resource exploration
and investment companies.
15.2. Proposed Directors
Joseph Amrit Wiley (aged 45), CEO
Mr Wiley founded Amryt and is a non-executive director of NASDAQ
listed Innocoll AG. Mr. Wiley has over 20 years of experience in
the pharmaceutical, medical and venture capital industries. Mr
Wiley opened and led Sofinnova Ventures' European office. He was
previously a medical director at Astellas Pharma where he liaised
with the marketing team and was involved in the launch of a number
of speciality pharmaceutical products. Prior to joining Astellas,
he held investment roles at Spirit Capital, Inventages Venture
Capital and Aberdeen Asset Managers (UK). Mr Wiley trained in
general medicine at Trinity College Dublin, specialising in
neurology. He has an MBA from INSEAD and is also a Member of the
Royal College of Physicians in Ireland.
Rory Peter Nealon (aged 48), CFO/COO
Mr Nealon was previously a board member of Trinity Biotech Plc
joining as Chief Financial Officer in January 2003. He was
subsequently appointed Chief Operations Officer in November 2007.
Mr Nealon left Trinity in 2014. Prior to joining Trinity Biotech
Plc, he was Chief Financial Officer of Conduit plc, an Irish
directory services provider with operations in Ireland, the UK,
Austria and Switzerland. Prior to joining Conduit he was an
Associate Director in AIB Capital Markets, a subsidiary of AIB
Group plc, the Irish banking group. Mr Nealon holds a Bachelor of
Commerce degree from University College Dublin, is a Fellow of the
Institute of Chartered Accountants in Ireland, a member of the
Institute of Taxation in Ireland and a member of the Institute of
Corporate Treasurers in the UK.
Ray Thomas Stafford (aged 69), Non-executive Director
Mr Stafford has worked in the pharmaceutical industry for thirty
years, he was Chairman, CEO and majority shareholder of the Tosara
Group who owned, manufactured and marketed the successful
international brand Sudocrem. Following the integration of Tosara
into the U.S. based NYSE listed company Forest Laboratories in 1988
Mr Stafford held numerous senior positions within that corporation
including CEO Forest UK and Ireland, CEO Forest Europe and since
1999 to him retiring from the business in 2014 following the sale
of Forest to Actavis (Allergan) in a US$28bn transaction Mr
Stafford was Executive Vice President Global Marketing. Separately
Mr Stafford was founder of what is today one of Ireland's leading
multichannel sales, marketing and distribution service providers
approved by the Irish Medicines Board to service the wholesale and
retail trade.
Anthony James Culverwell (aged 59), Non-executive Director
Mr Culverwell is a non-executive director of NASDAQ listed
Innocoll AG and has over 30 years' experience in analysing and
valuing pharmaceutical companies. Mr Culverwell joined Hoare Govett
in 1982, and then moved to Merrill Lynch in 1995, where he became
head of European pharmaceutical equity research. In 2004, Mr
Culverwell set up Sudbrook Associates, a healthcare corporate
adviser. Mr Culverwell currently sits on the board of four
companies in the specialty pharmaceutical, drug development and
diagnostic fields. Mr Culverwell has an MSc from the University of
Aberdeen.
15.3. Senior Management
Michele Bellandi is joining the Enlarged Group as Chief
Commercial Officer and has accepted an offer of employment,
effective from 1 April 2016. Dr Tobias Zahn will become an employee
of the Enlarged Group on Admission and Alan Harris will take up the
role as Head of the scientific advisory board, following completion
of the Birken SPA and Som SPAs. Brief summaries and biographies are
set out below:
Michele Bellandi, Chief Commercial Officer
Mr Bellandi has over 20 years' experience in the pharmaceuticals
industry with a focus on rare diseases. He was most recently the
Head of Commercial Europe for Shire AG International Plc where he
was responsible for the entire portfolio representing over US$1.0
billion in revenues and over 600 employees. Before becoming Head of
Europe he was General Manager of France, Spain and Portugal for the
rare disease business and conducted multiple pricing negotiations
of rare disease products. Prior to joining Shire AG International
he was Global Marketing Director for the Neurology franchise at
Serono (now Merck & Co., Inc) where he was responsible for
Rebif and led the international launch preparation of oral
Cladribine. Previously he worked with Eli Lilly & Company as
Cymbalta Global Marketing Manager and in several other global
marketing/sales management roles in the US, Italy and Japan. Mr
Bellandi holds a Masters in Economics from Pisa University and a
Masters in Business Administration from CUOA Business School
(Italy).
Alan Harris, Chairman, Scientific Advisory Board
Mr Harris was chairman and founder of Som. Prior to founding
Som, Mr Harris headed Clinical Development of octreotide
(Sandostatin(R)) at Sandoz (Novartis) which was approved for the
treatment of malignant neuroendocrine tumors and Acromegaly which
remains 25 years later the leading treatment for these
diseases.
Dr. Tobias Zahn, Head of Clinical Operations
Mr Zahn joined Birken in 2009 and was responsible for the
development of Episalvan. Prior to that he worked from 2005 to 2008
as a consultant at The Boston Consulting Group and from 2003 to
2004 as postdoc at the Max Planck Institute for Molecular Cell
Biology and Genetics in Dresden. He holds a Masters degree in
Biochemistry and a PhD in Cell Biology both from Witten/Herdecke
University, Germany. He has conducted research at the University of
Colorado Health Sciences Center.
16. The City Code on Takeovers and Mergers
The Company is subject to the Code. Brief details of the Panel,
the Code and the protections they afford are described below.
The Code is issued and administered by the Panel. The Code
applies to all takeover and merger transactions, however effected,
where the offeree company is, inter alia, a listed or unlisted
public company resident in the United Kingdom, the Channel Islands
or the Isle of Man (and to certain categories of private limited
companies). The Company is a public company resident in the United
Kingdom and its shareholders are therefore entitled to the
protections afforded by the Code.
(MORE TO FOLLOW) Dow Jones Newswires
March 31, 2016 02:01 ET (06:01 GMT)
Under Rule 9 of the Code ("Rule 9"), where any person acquires,
whether by a series of transactions over a period of time or not,
an interest in shares (as defined in the Code) which (taken
together with shares already held by him and any interest in shares
held or acquired by persons acting in concert with him) carry 30
per cent. or more of the voting rights of a company which is
subject to the Code, that person is normally required to make a
general offer to all the holders of any class of equity share
capital or other class of transferable securities carrying voting
rights in that company to acquire the balance of their interests in
the company.
Rule 9 of the Code also provides that, among other things, where
any person who, together with persons acting in concert with him,
is interested in shares which in aggregate carry not less than 30
per cent. but does not hold shares carrying more than 50 per cent.
of the voting rights of a company which is subject to the Code, and
such person, or any person acting in concert with him, acquires an
additional interest in shares which increases the percentage of
shares carrying voting rights in which he is interested, then such
person is normally required to make a general offer to all the
holders of any class of equity share capital or other class of
transferable securities carrying voting rights of that company to
acquire the balance of their interests in the company.
An offer under Rule 9 must be in cash (or with a cash
alternative) and at the highest price paid within the preceding 12
months for any shares in the company by the person required to make
the offer or any person acting in concert with him.
Rule 9 of the Code further provides, among other things, that
where any person who, together with persons acting in concert with
him holds over 50 per cent. of the voting rights of a company,
acquires an interest in shares which carry additional voting
rights, then they will not generally be required to make a general
offer to the other shareholders to acquire the balance of their
shares.
For the purposes of the Code, persons acting in concert comprise
persons who, pursuant to an agreement or understanding (whether
formal or informal), actively co-operate, through the acquisition
by them of shares in a company, to obtain or consolidate control of
that company.
17. Concert Parties
Certain persons are considered to be acting in concert with each
other in relation to the Company for the purposes of the Code
following Admission. There are three such concert parties, being
the Amryt Concert Party, the Som Sellers and the Birken Sellers.
Following completion of the Proposals, the Birken Sellers will
hold, in aggregate, 43,656,955 New Ordinary Shares, representing
21.0 per cent. of the Enlarged Share Capital and the Som Sellers
will hold, in aggregate, 12,277,102 New Ordinary Shares,
representing 5.9 per cent. of the Enlarged Share Capital.
Following completion of the Proposals, the Amryt Concert Party
will hold, in aggregate, 83,645,323 New Ordinary Shares,
representing 40.1 per cent. of the Enlarged Share Capital. In
addition, certain members of the Concert Party will, on Admission,
hold 4,130,208 options and/or 2,225,728 warrants to subscribe for
New Ordinary Shares in the Company on Admission. Should these
options and/or warrants be exercised by those members of the
Concert Party and assuming no other New Ordinary Shares are issued,
the Concert Party's maximum holding would be 90,001,259 New
Ordinary Shares, representing 41.9 per cent. of the Company's then
enlarged share capital which, without a waiver of the obligations
under Rule 9, would oblige the Concert Party to make a general
offer to Shareholders under Rule 9. Following Admission, Rule 9
will continue to apply to the Amryt Concert Party, requiring a
general offer to be made on any further acquisition of interests in
New Ordinary Shares by the Amryt Concert Party (unless a waiver is
obtained or the Amryt Concert Party acquires more than 50 per cent.
of the voting rights in the Company).
Following an application by the Independent Directors, the Panel
has agreed, subject to the approval of the Waiver Resolution on a
poll by Independent Shareholders at the General Meeting, to grant
the Waiver. The effect of the Waiver, if the Waiver Resolution is
approved by Independent Shareholders, would be that the Amryt
Concert Party would not be subject to a requirement to make a
general offer under Rule 9 that might otherwise arise as a result
of the Proposals. The Amryt Concert Party or any member of the
Amryt Concert Party will not be restricted from making an offer for
the New Ordinary Shares which it will not own following
Admission.
The Waiver Resolution is subject to the approval of a simple
majority of the Independent Shareholders on a poll and each
Independent Shareholder will be entitled to one vote for each
Existing Ordinary Share held. To be passed, the Waiver Resolution
will require the approval of a simple majority of votes cast on
that poll.
Cathal Friel, Non-Executive Chairman of Fastnet and director and
shareholder of Amryt, holds (including holdings by Raglan Capital,
a company owned by him and his wife Pamela Iyer) 39,751,525
Existing Ordinary Shares (representing 11.51 per cent of the
Existing Ordinary Shares) and shares in Amryt and is a member of
the Amryt Concert Party and is therefore considered a
Non-Independent Director.
Following completion of the Proposals, the members of the Amryt
Concert Party will be interested in New Ordinary Shares which carry
more than 30 per cent. but would not hold more than 50 per cent. of
the Company's voting share capital and, in such circumstances, any
further increase in the number of New Ordinary Shares will be
subject to Rule 9 of the Code.
The Amryt Concert Party and other non-independent parties will
not vote on the Waiver Resolution.
18. Change of accounting reference date
It has been resolved to change the Company's accounting
reference date to 31 December, conditional on Admission. As such,
the first full reporting period of the Enlarged Group will be for
the period ending 31 December 2015.
19. Change of name
Subject to the Shareholders' approval by way of a special
resolution, it is proposed, pursuant to Resolution 7, that the name
of the Company be changed to Amryt Pharma Plc shortly after the
General Meeting. If Resolution 7 to approve the change of name of
the Company is passed at the General Meeting, the Company's AIM
symbol will be changed to AMYT, its ESM symbol to AYP and its
website address will be changed to www.amrytpharma.com as soon as
possible. Resolution 7 is conditional on Shareholder approval of
the Acquisition.
20. General Meeting
Contained within the Admission Document is a notice convening
the General Meeting to be held at noon at London Conrad St James,
2228 Broadway, London SW1H OBH on 18 April 2016, for the purposes
of considering and, if thought fit, passing the Resolutions. A
summary of the Resolutions is as follows:
-- Resolution 1 is an ordinary resolution to approve the
Acquisition for the purposes of the AIM Rules, ESM Rules and
section 190 of the Act, subject to the passing of resolution 2.
-- Resolution 2 is the Waiver Resolution described in paragraph
17 above. It is an ordinary resolution which is conditional on the
passing of resolution 1 which will be taken on a poll of the
Independent Shareholders to approve the waiver of the requirement
contained in Rule 9 of the City Code for the Amryt Concert Party to
make a general offer to Shareholders as a result of the
Acquisition.
-- Resolution 3 is an ordinary resolution to approve, subject to
the passing of resolutions 1 and 2, the consolidation of every 8
Existing Ordinary Shares into one ordinary share of GBP0.304 each,
and the subsequent subdivision of each ordinary share of GBP0.304
each into 1 New Ordinary Share and 1 Deferred Share, as described
in paragraph 13 above.
-- Resolution 4 is an ordinary resolution to authorise, subject
to the passing of resolutions 1, 2 and 3 and conditional on the
Placing Agreement becoming unconditional save for Admission, the
Directors under section 551 of the Act to allot equity securities
up to an aggregate nominal amount of (i) GBP1,234,950.96 for the
issue of the Consideration Shares; (ii) GBP416,734.02 for the issue
of the Placing Shares; (iii) GBP208,366.96 for the issue of the
Placing Warrants; (iv) GBP20,732.55 for the issue of the Warrants;
(v) GBP416,679.26 otherwise following Admission; and (vi)
GBP416,679.26 in connection with an offer by way of rights issue.
The Company does not intend to allot any shares by way of rights
issue at this time but is seeking this authorisation in order to
overcome any legal or practical problems which might arise relating
to matters such as fractional entitlement or the laws of other
territories in the event of such an issue. The Company is proposing
to raise the amount set out in paragraph 12 above in respect of the
Placing Shares, which the New Board intends to utilise for the
purposes set out in paragraph 12 above.
-- Resolution 5 is an ordinary resolution to approve, subject to
the passing of resolutions 1 and 2, the adoption by the Company of
the new share option plan.
-- Resolution 6 is a special resolution to approve, subject to
the passing of resolutions 1, 2, 3 and 4, the disapplication of
statutory pre-emption provisions to allot equity securities for
cash other than on a non pre emptive basis (i) in connection with
an offer by way of rights issue; (ii) up to an aggregate nominal
amount of GBP1,234,950.96 in connection with the issue of the
Consideration Shares; (iii) up to an aggregate nominal amount of
GBP416,734.02 in connection with the Placing; (iv) up to an
aggregate nominal amount of GBP208,366.95 pursuant to the issue of
the Placing Warrants; (v) up to an aggregate nominal amount of
GBP20,732.55 pursuant to the issue of the Warrants; and (vi) up to
an aggregate nominal amount of GBP208,339.63 otherwise following
Admission.
(MORE TO FOLLOW) Dow Jones Newswires
March 31, 2016 02:01 ET (06:01 GMT)
-- Resolution 7 is a special resolution to approve, subject to
the passing of resolutions 1 and 2, the change of the name of the
Company to "Amryt Pharma plc".
-- Resolution 8 is a special resolution to approve, subject to
the passing of resolutions 1, 2 and 3, the amendments to the
Company's articles of association to, inter alia, set out the
rights attached to the Deferred Shares and to remove provisions
which applied where the Company was not subject to the Code.
The attention of Shareholders is also drawn to the
recommendations by and voting intentions of the Directors as set
out in paragraph 23 below.
21. Irrevocable undertakings to approve the Proposals
The Independent Directors have irrevocably undertaken to vote in
favour of the Resolutions to be proposed at the GM, in respect of
their and their associated companies' holdings totalling 4,283,779
Existing Ordinary Shares in aggregate, which represent
approximately 1.24 per cent. of the Existing Ordinary Shares.
In addition, Cathal Friel has irrevocably undertaken to vote in
favour of the Resolutions (other than the Waiver Resolution on
which he is prohibited from voting), at the GM, in respect of his
holdings (including for these purposes the holdings of Raglan
Capital which he owns, together with his wife, Pamela Iyer)
totalling 39,751,525 Existing Ordinary Shares in aggregate, which
represent approximately 11.51 per cent. of the Existing Ordinary
Shares.
22. Action to be taken
A Form of Proxy is enclosed for use by Shareholders at the GM.
Shareholders are asked to complete, sign and return the Form of
Proxy to the Company's Registrars, Capita Asset Services, at PXS,
34 Beckenham Road, Beckenham, Kent, BR3 4TU, as soon as possible
but in any event so as to arrive no later than noon on 14 April
2016, being two business days before the time appointed for the
holding of the General Meeting. The completion and return of a Form
of Proxy will not preclude Shareholders from attending the GM and
voting in person should they wish to do so. Accordingly, whether or
not Shareholders intend to attend the GM they are urged to complete
and return the Form of Proxy as soon as possible.
23. Recommendation
The Independent Directors, who have been so advised by Shore
Capital and Davy, consider that the Proposals are fair and
reasonable and in the best interests of the Independent
Shareholders and the Company as a whole. Furthermore the
Independent Directors, who have been so advised by Shore Capital,
consider that the Waiver is fair and reasonable and in the best
interests of the Independent Shareholders and the Company as a
whole. In providing advice to the Independent Directors, Shore
Capital has taken into account the Independent Directors'
commercial assessment.
Accordingly, the Independent Directors recommend that
Shareholders vote in favour of the Resolutions (other than the
Waiver Resolution) to be proposed at the General Meeting, as they
have irrevocably undertaken to do in respect of their own
beneficial holdings of 4,283,779 Existing Ordinary Shares,
representing 1.24 per cent. of the Company's issued share capital.
Furthermore the Independent Directors recommend that Independent
Shareholders vote in favour of the Waiver Resolution. Accordingly,
the Independent Directors unanimously recommend that Shareholders
approve the Resolutions by signing and returning the Form of Proxy
to the Company's Registrars.
-Ends-
This information is provided by RNS
The company news service from the London Stock Exchange
END
ACQSDWEFSFMSELD
(END) Dow Jones Newswires
March 31, 2016 02:01 ET (06:01 GMT)
Fastnet Equity (LSE:FAST)
과거 데이터 주식 차트
부터 12월(12) 2024 으로 1월(1) 2025
Fastnet Equity (LSE:FAST)
과거 데이터 주식 차트
부터 1월(1) 2024 으로 1월(1) 2025