Dr Joe Wiley, CEO of Amryt Pharma, said the positive outcome of the Phase 3 EASE trial marks another significant milestone for Amryt as it seeks approval for Filsuvez. AP103 is based on Amryt's gene-therapy platform technology and offers a potential treatment for patients with DEB, a subset of EB. Prior to Aegerion, he was at Bristol-Myers Squibb, where he led a large US medical affairs team within the cardiovascular and metabolics area. Dr Joe Wiley, CEO of Amryt Pharma, commented today: “We are very excited to report NICE’s approval of Myalepta® which will now give all England and Wales based patients suffering from … Mr.Wills also serves on the boards of: Caliper Corporation, since 2016; MediWound Ltd., since 2017; and Gamida Cell Ltd., since 2019. Dr Joe Wiley, CEO of Amryt Pharma, commented today: " We are pleased that ANVISA has recognised the significant unmet medical need of patients in Brazil suffering from HoFH and have … He has a Masters of Business Administration from INSEAD and is also a Member of the Royal College of Physicians in Ireland. Amryt Receives Reimbursement Approval from NICE for Myalepta® (metreleptin) in England and Wales DUBLIN, Ireland, and Boston MA, January 20, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, … Gerry has over 25 years’ experience in the pharmaceutical sector. This includes roles of increasing responsibility in sales, marketing and operations at G.D. Searle, Abbott, (now AbbVie), Amylin and Horizon Pharmaceuticals. Dr.Wiley will continue as Chief Executive Officer of the Enlarged Group for no less than two years after Closing, unless he resigns or is removed from the position by a vote of a majority of the Board. AP103 is based on a new gene therapy delivery platform, in-licensed by Amryt in March 2018, that utilises a non-viral delivery vector, HPAE (Highly Branched Poly B-Amino Ester), designed to deliver the correct collagen VII gene into skin cells. He serves on the board of IMAC (NASDAQ: IMAC) regeneration centers, public regenerative medicine centers. The MarketWatch News Department was not involved in the creation of this content. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. He has a PhD in Neuropharmacology from the University of Wales, Cardiff. by. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. Orphan drug designation may allow Amryt to be eligible for a seven-year period of U.S. Marketing exclusivity upon approval of AP103 and a waiver of the Prescription Drug User Fee Act ("PDUFA") filing fees, subject to certain conditions. For more information on Amryt, including products, please visit www.amrytpharma.com. View Joseph Wiley’s professional profile on Relationship Science, the database of decision makers. DUBLIN, Ireland, and Boston MA, December 23, 2020, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, is pleased to announce today that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation for AP103 for the treatment of Dystrophic Epidermolysis Bullosa ("DEB"). He has a Masters of Business Administration from INSEAD and is also a Member of the Royal College of Physicians in Ireland. Dr. Joe Wiley Chief Executive Officer (CEO). Mr. Stern was previously a director of Novelion until September 2019, and previously a member of Aegerion’s board of directors from September 2015 through to October 2016.Mr. Myalept(R) / Myalepta(R) (metreleptin) is approved in the US (under the trade name Myalept(R)) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta(R)) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. FILSUVEZ(R) has been selected as the brand name for the product. He has been a member of the Scientific Committee of the French drug agency. He is an independent board member of Hybrigenics S.A., Auris Medical Holding AG and Zealand Pharma A/S. Dr. Munoz worked with the Fournier Group, as Research and Development director and then Senior Vice President of the Pharmaceutical Division. Prior to joining, she was Medical Director EMEA at Aegerion Pharmaceuticals, where she was responsible for the medical activities supporting Lojuxta (lomitapide), a treatment for Homozygous Familial Hypercholesterolaemia (HoFH). Dr. Wiley trained in general medicine at Trinity College Dublin, specialising in neurology. A Fellow of the Chartered Institute of Personnel and Development Julie holds a Master’s Degree in Administration and Law. Prior to joining Currax, Mr. Hampton served as executive vice president, primary care business unit for Horizon Pharmaceuticals (HZNP), a public biopharmaceutical company. By continuing to surf this website you explicitly agree to the use of cookies on this website. Prior to that, he was the Chief Financial Officer (from 2003), Chief Operating Officer (from November 2007) and Board Member of Trinity Biotech plc, a diagnostic company listed on Nasdaq. ... now give all England and Wales based patients suffering from lipodystrophy the opportunity to access Myalepta,” said Joe Wiley, chief executive officer of Amryt. Joe Wiley, CEO of Amryt Pharma, commented: "Receiving an orphan drug designation from the FDA for our gene-therapy candidate, AP103, is a significant development for patients … See the complete profile on LinkedIn and discover Joseph’s connections and … The FDA's Office of Orphan Products Development ("OOPD") grants orphan drug designation to support the development of medicines for rare diseases, that affect fewer than 200,000 people in the United States. Julie has over 25 years’ experience in HR. Myalepta® received marketing authorisation from the European Medicines Agency (“EMA”) in 2018. He holds a BSc. Dr. Wiley founded Amryt and has over 20 years of experience in the pharmaceutical, medical and venture capital industries. Gerry has a PhD in Chemistry, Black belt in Lean/ Quality Systems and most recently became a certified Business Coach. Dr Joe Wiley, CEO of Amryt Pharma, commented today: “We are very excited to report NICE’s approval of Myalepta® which will now give all England and Wales based patients suffering from … Amryt Granted Orphan Drug Designation by the FDA for AP103. She joined Amryt in June 2019. Dr. Helen Phillips Head of Medical Affairs. Such forward-looking statements reflect the Company's current beliefs and assumptions and are based on information currently available to management. Mr. Stafford retired in 2014 following the sale of Forest Laboratories, Inc. to Actavis Plc (now Allergan Plc) in a US $28 billion transaction where Mr. Stafford was Executive Vice President of Global Marketing. Rory Nealon Chief Financial Officer and Chief Operating Officer (CFO & COO), Chief Financial Officer and Chief Operating Officer (CFO & COO). Many of these risks and uncertainties relate to factors that are beyond each of Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Dr Joe Wiley, CEO of Amryt Pharma, commented today: “We are very excited to report NICE’s approval of Myalepta® which will now give all England and Wales based patients suffering from … While there, he had clinical development, medical affairs and pharmacovigilance responsibility for the global approval and launch of a new treatment, Lojuxta®▼(lomitapide), for the serious and rare genetic disease, Homozygous Familial Hypercholesterolemia. (C) Copyright 2020 GlobeNewswire, Inc. All rights reserved. Dr.Vink has significant experience as a senior executive having worked in the pharmaceutical industry for more than 30 years. He led the clinical and scientific interactions with global health authorities, including the US Food and Drug Administration. The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary. Dr Helen Phillips joined Amryt Pharma in December 2016. Mr. Wills also served as the lead director of Derma Sciences, Inc. until December 2015 and as Chief Financial Officer from 1997 to 2000. Mr. Stern has served as the United States Attorney for the District of Massachusetts, the Chief Legal Counsel to Governor Michael S. Dukakis and the Chief of the Government Bureau in the Massachusetts Attorney General’s office. Tosara was integrated into the US based NYSE listed company Forest Laboratories, Inc. in 1988. Is there a problem with this press release? While serving at these companies, Dr. Vink has been involved in initial public listings, geographic expansions and contributed to the achievement of meaningful development and commercial milestones. Gerry Gilligan Head of Manufacturing Supply Chain. Mr. Stafford held numerous senior positions within that corporation including Chief Executive Officer of Forest UK and Ireland as well as Chief Executive Officer of Forest Laboratories Europe since 1999. Dr. Vink also serves as Chairman of venture capital backed NMD Pharma ApS, a neurology biopharma company in Denmark and F2G Ltd, a rare fungal disease UK- and Austria-based company. He also previously worked at Ethicon, a Johnson & Johnson medical device company, where he was responsible for the clinical group. He joined the Fournier Group from Sanofi Group, where he started as director in the cardiovascular and anti-thrombotic products department and then asVice President international development. He is advisor to Kurma Partners and serves on the scientific advisory board of Valneva SA. In this role he was tasked with leading the forward-looking strategy, as well as establishing operational goals for the business. He was Chairman, Chief Executive Officer and majority shareholder of the Tosara Group who owned, manufactured and marketed the successful international brand Sudocrem. During this time, he played a pivotal role in multiple product launches, redefining portfolio and brand strategies, and multiple organisational change projects, whilst contributing to development of a new operating model for the EMEA region. Joe Wiley, CEO of Amryt Pharma, commented: “Receiving an orphan drug designation from the FDA for our gene-therapy candidate, AP103, is a significant development for patients … Prior to joining Amryt, Derval was Senior Director of Regulatory Affairs for the NASDAQ‐listed rare diseases company Retrophin Inc., where she provided regulatory, strategic and operational input to product teams managing Retrophin’s development‐stage and commercial products. Kieran Rooney VP, Strategic Alliances and Licensing. Prior to joining Amryt, he was President Europe, Middle East and Africa (EMEA) at Aegerion Pharmaceuticals, where he was responsible for the commercialisation of Lojuxta (lomitapide), a treatment for Homozygous Familial Hypercholesterolemia (HoFH) recently in-licensed by Amryt Pharma. Hampton earned his Bachelor of Science from Miami University in Oxford, Ohio. Lucy Parsons. Amryt Pharma PLC (LON:AMYT) (NASDAQ:AMYT) noted that support groups for people suffering from eating disorder leptin deficiency said they were 'ecstatic' after its treatment for the condition, Myalepta, … Mr. Hampton joined Currax Pharmaceuticals in April of 2019 as Chief Executive Officer and serves on its board of directors. Mr. Wills is a certified public accountant and earned his Bachelor of Science in accounting from West Chester University and a Master of Science in taxation from Temple University. She has a degree in Medicine from Bristol University Medical School and spent six years in the NHS in General Practice. Joseph has 9 jobs listed on their profile. These statements are not guarantees of future performance or the ability to identify and consummate investments. Dr. Wiley founded Amryt and has over 20 years of experience in the pharmaceutical, medical and venture capital industries. His experience has spanned Supply chain, API, Development, Solid Oral dosage, Semi Solid formulations, Bulk Manufacturing and Aseptic fill finish. Joe Wiley, CEO of Amryt Pharma, commented:"Receiving an orphan drug designation from the FDA for our gene-therapy candidate, AP103, is a significant development for patients suffering from EB and provides additional momentum to our development pipeline. Amryt’s Myalepta scores NICE backing for rare lipid disorder. He has also been a Board Member and Chief Financial Officer of Conduit plc, an Irish directory services provider with operations in Ireland, the UK, Austria and Switzerland, as well as an Associate Director at AIB Capital Markets, a subsidiary of AIB Group plc, the Irish banking group. He graduated as a medical doctor from the University of Leiden, Netherlands in 1988 and obtained his Masters of Business Administration in 1992 at the University of Rochester. Dr Joe Wiley, CEO of Amryt Pharma, commented today: “ We are very excited to report NICE’s approval of Myalepta® which will now give all England and Wales based patients suffering from … Stern is Managing Director of Corporate Monitoring & Consulting Services at Affiliated Monitors Inc., a consulting firm providing independent integrity monitoring services and compliance services across a wide range of regulated industries and professions. He has almost 20 years’ experience across the pharmaceutical, medical devices and biotech industries, both in the US and UK. Joe Wiley, CEO of Amryt Pharma, commented:“Receiving an orphan drug designation from the FDA for our gene-therapy candidate, AP103, is a significant development for patients suffering … Metreleptin is also approved for lipodystrophy in Japan. David Allmond Chief Commercial Officer (CCO). To configure permissions in more detail please click here. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease. Unlike other gene therapies that rely on viral vectors, AP103 is based on a novel polymer-based topical delivery platform, which we believe offers potential advantages in the gene-therapy field and has potential to be used in other genetic skin conditions.". He has more than 25 years of experience as a successful executive in the pharmaceutical and biotech field on both a national and international scale including specific expertise in rare disease (ACTIMMUNE, RAVICTI, PROCYSBI), autoimmune (HUMIRA), primary care, orthopedic (CELEBREX), diabetes (BYETTA), anti-infectives and cardiovascular spaces. Now my brother wants half, COVID-19 may accelerate these 3 trends in real estate, Nasdaq touches record high but Dow lags in Monday morning trade as investors brace for busiest week of earnings. Mr. Stern holds a Masters in Laws from University of Pennsylvania Law School, a Juris Doctor degree from Georgetown University Law Center and a Bachelor of Arts from Hobart College. Her former experience has included working as HR Director in Total mobile, TV3 and Oxigen. View Joseph Wiley’s profile on LinkedIn, the world’s largest professional community. Dr. Vink serves as Chairman at Acacia Pharma Group plc and Targovax ASA, both publicly listed biopharma companies based in the UK and Norway. Before that, Derval worked for 11 years as a Managing Consultant at Real Regulatory Ltd, a consultancy specialising in European regulatory affairs, quality management systems and supply chain operations compliance. He has been a partner at three major law firms including Cooley LLP, Bingham McCutchen LLP, and Hale & Dorr LLP (now Wilmer Cutler Pickering Hale and Dorr LLP). His most recent rolls have included Director of Manufacturing, Director of Operations and Site Lead at LEO Pharma. Kieran Rooney joined Amryt Pharma as VP, Strategic Alliances and Licensing, in August 2017. Dr Joe Wiley, CEO of Amryt Pharma, commented today: “We are very pleased that the Ministry of Health in the Kingdom of Saudi Arabia has approved the reimbursement of Lojuxta® which … Supreme Court calls emoluments lawsuits against Trump moot, Supreme Court dismisses as moot emoluments suits against Trump, Apple price target gets a boost at Raymond James, ‘I’m tired of being the only one with moral values’: My mother put me on the deed of her home. HoFH is a rare genetic disorder which impairs the body's ability to remove low density lipoprotein ("LDL") cholesterol ("bad" cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth - often ten times more than people without HoFH - and subsequent aggressive and premature cardiovascular disease. Rory Nealon co-founded Amryt Pharma in August 2015. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. He was also responsible for EMEA marketing and market access. Amryt's lead development candidate, FILSUVEZ(R) (Oleogel-S10) is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Prior to joining Astellas Pharma Limited, he held investment roles at Spirit Capital SA, Inventages Venture Capital Investment Inc. and Aberdeen Asset Managers Private Equity Limited. Prior to that, Dr. Rooney worked as a consultant to the UK Government and held business development roles at Smith & Nephew, F2G Limited, Pharsight Corporation, and MDS Pharma Services, among others. Dr Mark Sumeray joined Amryt Pharma in September 2016. To see what cookies we use and set your own preferences please review the cookie notice in our Privacy Policy. In addition, Dr. Vink is a board member at Santhera AG and Spero Therapeutics Inc and since 2019 began working with Athyrium as a Senior Advisor. Previously, Mr. Hampton served as executive vice president, global orphan business unit and international operations for Horizon Pharmaceuticals. Dr Joe Wiley, CEO of Amryt, commented: “2019 was a truly transformational year for Amryt. He spent nine years in clinical practice in the NHS, specialising in cardiovascular surgery and physiology, having qualified as a medical doctor at the University of London. Joe Wiley, CEO of Amryt Pharma, commented: “Receiving an orphan drug designation from the FDA for our gene-therapy candidate, AP103, is a significant development for patients suffering from EB and … Contact the source provider Comtex at editorial@comtex.com. He has led organisations through significant operational transformation and been involved in acquisitions of companies and product portfolios. This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014. She has significant experience in Employee Relations, Employee Engagement, Training and Development, Recruitment and Selection and in Acquisitions. Dr Joe Wiley, CEO of Amryt Pharma, commented today: “We are very pleased that the Ministry of Health in the Kingdom of Saudi Arabia has approved the reimbursement of Lojuxta® which … Amryt comprises a strong and growing portfolio of commercial and development assets. In a statement, Joe Wiley, Amryt Pharma’s chief executive, said: “We are very excited to report NICE’s approval which will now give all England and Wales based patients suffering from … He was previously a medical director at Astellas Pharma Limited where he liaised with the marketing team and was involved in the launch of a number of specialty pharmaceutical products. About AmrytAmryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Her experience has been in multiple sectors in the UK and Republic of Ireland including Construction, Television, Technology and Waste Management. Dec 23, 2020 (GLOBE NEWSWIRE via COMTEX) -- Amryt's commercial business comprises two orphan disease products. Most recently Stephen was General Manager, Switzerland at Astellas Pharmaceuticals AG, and prior to that he was Area Marketing & Market Access Director at Astellas Pharma EMEA. Mr. Stafford has worked in the pharmaceutical industry for thirty years. Dr. Joe Wiley Chief Executive Officer (CEO) Dr. Wiley founded Amryt and has over 20 years of experience in the pharmaceutical, medical and venture capital industries. In March 2018, Amryt in-licensed a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders. He 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. The product has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration. Joe Wiley, CEO of UK-based Amryt Pharma, is steering a road-less-traveled path from the small-pharma playbook—building a sustainable, commercial infrastructure first, with the hopes of … Please confirm you wish to follow this link. Derval O’Carroll Head of Regulatory Affairs, Derval has over 25 years’ experience in pharmaceutical industry regulatory affairs. Most recently, he spent five years as Chief Medical Officer at Aegerion Pharmaceuticals, a US-based orphan disease biotech company. He has had a diverse and distinguished legal career, evenly split between private practice and public service. The link you have selected is not under the review or control of Amryt Pharma and, as such, the company does not endorse the content, its accuracy, or any practices or standards contained within it. Dr. Wiley trained in general medicine at Trinity College Dublin, specialising in neurology. Amryt Chief Executive Officer Joe Wiley said the Phase III readout represents an important advancement for patients and families living with EB, a genetic skin disorder that causes the … Prior to joining Amryt, he was Managing Director of Halo BioConsulting, a global healthcare advisory services firm he founded in 2007, which focused on business alliances and management consulting. Dr. Phillips has over 20 years’ experience in Medical Affairs, working in UK, European and Global roles for AstraZeneca, GSK and Hospira, as well as biotech start-up companies, Aspreva and Vanda. He was previously a medical director at Astellas Pharma Limited where he liaised with the marketing team and was involved in the launch of a number of specialty pharmaceutical products. Between 2007 and 2017, he worked with over 30 pharmaceutical, biotechnology and professional service companies, including, most recently, Amakem Therapeutics and PwC. Mr.Wills serves as the Chief Financial Officer, since 1997, and Chief Operating Officer, since 2011, of Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Joe Wiley is CEO/Co-Founder at Amryt Pharma Ltd. See Joe Wiley's compensation, career history, education, & memberships. Joe Wiley, CEO of Amryt Pharma, commented: “Lomitapide is an important contributor to Amryt’s commercial performance and growth and today’s announcement demonstrates the progress we are … Stephen joined Amryt Pharma as VP, Global Marketing in December 2018 with over 15 years’ experience in the pharmaceutical industry across multiple therapy areas. Dr Joe Wiley, CEO of Amryt Pharma, commented today: “We are very excited to report NICE’s approval of Myalepta® which will now give all England and Wales based patients suffering from … Dr Joe Wiley, CEO of Amryt Pharma, commented today: "We are very pleased that the Ministry of Health in the Kingdom of Saudi Arabia has approved the reimbursement of Lojuxta® which … You can also contact MarketWatch Customer Service via our Customer Center. Joseph Wiley is Chief Executive Officer & Executive Director at Amryt Pharma Plc. Dr Joe Wiley, CEO of Amryt Pharma, commented today: “We are very excited to report NICE’s approval of Myalepta® which will now give all England and Wales based patients suffering from … Over 20 years of experience in pharmaceutical industry regulatory Affairs, derval has over 20 ’... 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