AMRYT PHARMA PLC
(“Amryt” or the “Company”)
VIRTUAL ANALYST AND INVESTOR EVENT - TUESDAY NOVEMBER 3, 2020 -
AMRYT TO PRESENT FULL DATA FROM EASE TRIAL AND LAUNCH PLANS FOR FILSUVEZ® AS A POTENTIAL TREATMENT FOR EB
DUBLIN, Ireland, and Boston MA, October 9 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, announces that the Company will host a virtual Analyst and Investor Event on Tuesday, November 3 2020 from 0830 EST (1330 GMT) - 1030 EST (1530 GMT) to present full data from its pivotal EASE Phase 3 trial of FILSUVEZ® (previously AP101 /Oleogel-S10) for the potential treatment of dystrophic and junctional Epidermolysis Bullosa (“EB”).
This virtual event will take place shortly after Amryt presents EASE top line trial data at the 29th EADV (European Association of Dermatology and Venereology) Virtual Congress 2020 on October 31. At the Virtual Analyst and Investor event on November 3, Amryt will address the following topics:
EASE Phase 3 full trial data
Regulatory agency engagement and timelines
Commercialization and launch plans
Amryt management will be joined at the event by Professor Jemima Mellerio (Consultant Dermatologist & Honorary Professor of Paediatric Dermatology, Chief St John’s Institute of Dermatology, Guy’s and St Thomas’ Hospital, London) who will discuss the EASE data. The group will also be joined by Brett Kopelan (Executive Director, debra of America and President, DEBRA International) and Jimmy Fearon (CEO, DEBRA Ireland and VP, DEBRA International) who will be available to answer questions from participants.
Prof Jemima Mellerio trained in dermatology in South London at St John’s Institute of Dermatology and King’s College Hospital. Undertaking her MD at St John’s Institute on Genotype-Phenotype Correlations in EB sparked an interest in genetic skin fragility disorders that has endured. She has been a consultant dermatologist since 2003 and is based at St John’s Institute of Dermatology, Guy’s and St Thomas’ Hospital, London where she is Chief of Dermatology and leads the Adult EB Service which provides clinical care for around 500 individuals with EB. She also worked as the dermatologist to the Paediatric EB Service at Great Ormond Street Hospital for almost 15 years until recently. Jemima’s clinical interests are EB, Mendelian genodermatoses, and general paediatric dermatology. She has established a large tertiary referral service at St John’s for both adults and children with genetic skin disease, overseeing the care of a large cohort of patients with ichthyosis, palmoplantar keratodermas, other disorders of keratinisation and ectodermal dysplasias. She has active clinical and laboratory research interests in many different aspects of genetic skin disease including gene discovery and phenotyping, a longitudinal prospective study in recessive dystrophic EB, and translational research of new therapies for genodermatoses including cell and gene therapy. She has published widely and lectured nationally and internationally on these areas.
Brett Kopelan was initiated into the world of rare diseases ten years ago when his daughter was born with a severe form of Recessive Dystrophic Epidermolysis Bullosa (“RDEB”). Shortly after her birth, Brett was elected to the board of directors of the Dystrophic Epidermolysis Bullosa Research Association of America (debra of America). Upon returning to New York City after his daughter was the 8th child in the world to undergo a stem cell transplant in hopes of treating her RDEB, he became the Executive Director of debra of America, the only national not-for-profit providing all-inclusive support to the EB community. He currently serves as: President of the board of directors of the Coalition of Skin Diseases; Treasurer on the board of directors of debra international (a consortium of 55 nongovernmental organizations dedicated to curing EB); and, Secretary on a 50-year old financial services firm's board of directors. Brett also formerly served as both the Chairman of the board of directors, and as the treasurer of the National Organization for Rare Disorders (“NORD”). Prior to his rare disease work, Brett was an accomplished entrepreneur, starting three different companies raising more than $30 million in venture financing, where he led business development and marketing. He has a graduate degree from Columbia University and an undergraduate degree from New York University.
Jimmy Fearon is CEO of DEBRA Ireland and Vice President of DEBRA International. Jimmy has worked for ten years as CEO of DEBRA Ireland. From an organisational perspective, his focus is simply - what does really good look like? How do we get there? In DEBRA's case good looks like closing the gap between what the patients need and what they receive from the state. The gap is wide. To this end DEBRA has established the EB Community Care Programme to create a high standard of support in the home and community. Good also looks like finding a cure and better treatments for the people currently living with EB. To this end, DEBRA has invested in numerous research projects partnering with other DEBRA’s around the world through DEBRA International. Jimmy has worked hard to create an organisation that is in constant pursuit of excellence, and one that identifies opportunities and converts them to outputs for patients and their families. His ability to bring about improvement is based on his previous work experience with KPMG and their blue chip client base and with Dataconversion Direct where he provided long-term business solutions to organisations like Paddy Power, Unilever, Bank of Ireland, Sky, Dell and Tesco. His board experience includes IDMA, IPOSSI, DEBRA International and Dataconversion Direct. Prior to joining the charity sector Jimmy worked as a volunteer for Irish Cancer Society, St Vincent De Paul Homeless Shelter and Rotary.
About EASE and FILSUVEZ®
The EASE trial is the largest ever global Phase 3 trial conducted in patients with EB, performed across 58 sites in 28 countries. FILSUVEZ® is a potential treatment for the cutaneous manifestations of EB. In September 2020, Amryt announced that the EASE trial achieved its primary endpoint. FILSUVEZ® has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration.
EB is a rare, chronic and distressing genetic skin disorder that causes the skin layers and internal body linings to separate and affects infants, children and adults. The global incidence of EB is estimated to be approximately 1 in 20,000, which implies that there are as many as 30,000 affected individuals in the US and over 500,000 worldwide. There are currently no approved treatments.
Amryt Pharma plc
+353 (1) 518 0200
Joe Wiley, CEO
+1 (212) 915 2564
+44 (0) 20 3709 5700
Amber Fennell, Matthew Neal, Ashley Tapp
Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.
Amryt’s commercial business comprises two orphan disease products.
Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan (under the trade name Juxtapid®) and in the EU (under the trade name Lojuxta®). 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.
Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) 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®) 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. Metreleptin is also approved for lipodystrophy in Japan. 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.
Amryt's lead development candidate, FILSUVEZ® is a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. In September 2020, Amryt reported positive top line results from its pivotal global phase 3 trial of FILSUVEZ® in EB. FILSUVEZ® has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration.
In March 2018, Amryt in-licenced a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders.
For more information on Amryt, including products, please visit www.amrytpharma.com.
This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014.
The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary.
Shore Capital (Edward Mansfield, Daniel Bush, John More) are NOMAD and Joint Broker to Amryt in the UK. Stifel (Ben Maddison) are Joint Broker to the company in the UK. Davy (John Frain, Daragh O’Reilly) act as Joint Broker to the company.
Statements in this announcement with respect to Amryt's business, strategies, timing for completion of and announcing results from the EASE trial, the potential impact of closing enrollment in the EASE trial, as well as other statements that are not historical facts are forward-looking statements involving risks and uncertainties which could cause the actual results to differ materially from such statements. Statements containing the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. 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. 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. These statements are not guarantees of future performance or the ability to identify and consummate investments. 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. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. 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. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.