Big picture - Why invest in Amryt Pharmaceuticals
Amryt Pharmaceuticals Snapshot
Amryt is a commercial stage 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 address some of these rare and debilitating illnesses.
The Company holds an exclusive licence to sell Lojuxta (lomitapide) for adults, across the EU and other territories including the Middle East, North Africa, Turkey and Israel. Lojuxta is used to treat a rare life-threatening disease called Homozygous Familial Hypercholesterolemia, which impairs the body's ability to remove LDL cholesterol ("bad" cholesterol) from the blood. This typically results in extremely high blood LDL cholesterol levels leading to aggressive and premature narrowing and blocking of arterial blood vessels. If left untreated, heart attack or sudden death may occur in childhood or early adulthood.
Amryt's lead drug candidate, AP101 (Episalvan), is a potential treatment for Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children for which there is currently no treatment. It is currently in Phase 3 clinical trials.
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.
The Company joined AIM and Dublin's ESM in April 2016 following the reverse takeover of Fastnet Equity PLC.
Rare Diseases and Pipeline
Amryt’s Products are Targeting Multiple Orphan Diseases
Epidermolysis Bullosa is a rare, distressing and painful genetic skin disorder characterised by blistering, erosion or poorly healing ulceration of the skin, and, in some cases, the epithelial lining of other organs. Mutations in the genes of patients with the disorder mean proteins such as collagen and keratin, which are involved in the structure and function of their skin, do not function properly. As a result, patients’ skin is subject to severe blistering, open wounds and scarring in response to minor friction. EB is chronic, debilitating and potentially disfiguring and fatal. In the severest forms of the disease, patients are diagnosed in infancy.
Patients with EB have painful wounds and blisters affecting a substantial percentage of their bodies that can also lead to infection and scarring. There are four main types of EB of differing severity of disease. The type of disorder is dependent on the genetic mutations a patient has.
EB Simplex is typically the mildest form of the disease where blistering is frequently restricted to just the hands and feet.
Dominant dystrophic and recessive dystrophic forms of the disease are more severe than EB Simplex. Dystrophic EB derives its name from the tendency of the blisters to heal with scarring. This process can lead to contraction of the joints, fusion of the fingers and toes, contraction of the mouth membranes and narrowing of the oesophagus. There is a high chance of recessive dystrophic EB sufferers developing squamous cell carcinoma of the skin (a form of skin cancer) before the age of 35.
Junctional EB in its generalised severe form (Herlitz-subtype) is the most severe form of EB and most children born with it do not survive beyond the age of three.
All types of EB share the common symptom of fragile skin that blisters and tears from the slightest friction or trauma.
Acromegaly is a rare endocrine disorder that most commonly results from an adenoma, a benign tumour of the pituitary gland that secretes excessive growth hormone (GH) and leads to excess production of the hormone IGF-1. A common criterion for the successful treatment of acromegaly is normalisation of IGF-1 levels, since reduction of excess IGF-1 correlates closely with relief of clinical symptoms. The progression of acromegaly is typically slow, and acromegaly often is not clinically diagnosed for 10 years or more. As the disease advances, patients typically exhibit abnormal growth throughout the body. Acromegaly most commonly affects middle-aged patients with the mean age of onset being 40 to 45 years. The symptoms associated with acromegaly typically include the effects seen with growth hormone over-production. In some instances, the tumour compressing and injuring the normal pituitary gland and optic nerves also causes symptoms. Untreated acromegaly results in marked bone and soft tissue changes including altered facial appearance, enlargement of the hands and feet, sleep apnoea, and carpal tunnel syndrome. More serious problems may include accelerated cardiovascular disease, hypertension, diabetes mellitus and possibly an increased risk of colon cancer. If the tumour develops before bone growth is completed in adolescence, the result will be gigantism. Because of the serious systemic changes resulting from growth hormone excess, treatment is essential, typically with surgery. However, a significant number cases, surgery is either not appropriate or not effective. In these patients, a somatostatin analogue is typically used. These mimic the effects of somatostatin, a hormone produced by the hypothalamus and some other tissues such as the pancreas and the gastrointestinal tract. Somatostatin inhibits the release of growth hormone from the pituitary gland. However, it also inhibits the release of insulin and glucagon from the pancreas, which is why somatostatin analogues, which retain these peripheral activities, are also associated with causing diabetes.
In addition to acromegaly, somatostatin analogues have also been approved for the treatment of neuroendocrine tumours and Cushing’s disease. Cushing’s disease is typically caused by a benign pituitary tumour that secretes adrenocorticotrophin (ACTH). This in turn stimulates cortisol secretion from the adrenal gland. These patients are believed to have a mortality risk five times that of the general population, with cardiovascular events being the primary cause of death. According to Strongbridge BioPharma, an estimated 25,000 patients in the US and 40,000 patients in Europe are currently diagnosed with Cushing’s syndrome of which 70-80% have Cushing’s disease. Patients are most commonly adults aged 20 to 50 and five times more women than men are affected. However, endogenous Cushing’s syndrome is believed to be underdiagnosed due to lack of disease recognition by the treating physician, which often leads to a delay in diagnosis of six years on average.
HoFH (homozygous familial hypercholesterolemia) is an uncommon genetic condition that is inherited from both parents and leads to high levels of cholesterol in your blood. People with HoFH have blood cholesterol levels that are exceptionally high, usually between 10 and 20 mmol/L and possibly even higher. At these levels, the cholesterol accumulates in the arteries much faster than in the normal population leading to premature heart disease. People with HoFH do not always respond to usual lipid lowering drugs such as statins and so need other therapies to lower their cholesterol levels.
Lojuxta® (lomitapide) capsules is a prescription medicine used along with diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL (“bad”) cholesterol, total cholesterol, a protein that carries bad cholesterol in the blood (apolipoprotein B), and non-high-density lipoprotein cholesterol (non-HDL-C).
Episalvan® is a prescription pharmaceutical product which has been demonstrated to accelerate wound healing in adult patients with partial thickness wounds (PTW). It’s approved in Europe for the treatment of PTWs in adults. Such wounds include burns, split thickness skin graft (STSG) donor sites, dermatological and aesthetic procedures, decubitus ulcers (stage II), toxic epidermal necrolysis and radiation and drug side effects.
Episalvan® is a topical product which is formulated to contain two ingredients, its betulin-based active ingredient and sunflower oil as the only excipient.
Many people suffer from dry, itching and allergic skin or face trouble with atopic dermatitis and psoriasis that affects daily life. These conditions require special care.
The Imlan® products’ regenerative and anti-inflammatory properties have transformed skin care. Betulin is the active ingredient in the Imlan® products and also functions as the stabilizer of the creams and lotions. This eliminates the use of emulsifiers and preservatives that are usually found in skin care products and that are for many a cause of skin irritation. Imlan® is a 100-percent natural skin care line that contains no colorants, fragrances, paraffin or lanolin. Imlan® Creme Pur contains just three ingredients: Betulin, oil and water.
Board of Directors
Harry Stratford – Non-Executive Chairman
Harry Stratford, Non-Executive Chairman, 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.
Joe Wiley – CEO
Joe Wiley, CEO, 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. 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 is also a Member of the Royal College of Physicians in Ireland and also has an MBA from INSEAD.
Rory Nealon – CFO/COO
Rory Nealon, CFO/COO, 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 Stafford – Non-Executive Director
Ray Stafford, Non-Executive Director, 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 multi-channel sales, marketing and distribution service providers approved by the Irish Medicines Board to service the wholesale and retail trade.
James Culverwell – Non-Executive Director
James Culverwell, Non-Executive Director, 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, including NASDAQ-listed Innocoll AG.
Mr Culverwell has an MSc from the University of Aberdeen.
Markus Ziener - Non - Executive Director
Markus Ziener joined Software AG Stiftung in 2013 as a Director of Asset Management before becoming Chief Financial Officer in August 2014. Prior to joining Software AG Stiftung, a 20.9% shareholder in Amryt, Mr Ziener worked in a number of senior roles across a broad range of industries including as Managing Director of Handelskontor Willmann für Naturprodukte and as CEO of GeckoGroup AG wetzlar Vorstand
For information on the Senior Management team, please click here
Total number of shares issued: 208,339,631
Number of shares (if any) held in treasury: Nil
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