AMYT Amryt Pharma Plc

 
TIDMAMYT 
 
   Amryt and Medison Pharma Sign Multi-Regional Distribution Agreements in 
Canada and Israel 
 
   DUBLIN, Ireland, and Boston MA, February 4, 2021, Amryt (Nasdaq: AMYT, 
AIM: AMYT), a global, commercial-stage biopharmaceutical company 
dedicated to acquiring, developing and commercializing novel 
therapeutics to treat patients suffering from serious and 
life-threatening rare diseases, today announces the signing of 
multi-regional distribution agreements with Medison Pharma ("Medison") 
to distribute Juxtapid(R) (lomitapide) in Canada and Lojuxta(R) 
(lomitapide) and Myalept(R) (metreleptin) in Israel. 
 
   Dr Joe Wiley, CEO of Amryt Pharma, commented today: "Today's 
announcement is another positive development as we continue to grow our 
commercial assets in existing and new territories and we further 
progress towards our goal of becoming a global leader in rare and orphan 
diseases. We are excited to be working with Medison to leverage their 
expertise and presence in these territories." 
 
   About Amryt 
 
   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. 
 
   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.  Filsuvez(R) has been selected as the brand name for the 
product. Amryt does not have regulatory approval for Filsuvez(R) to 
treat EB. In September and October 2020, Amryt reported positive results 
from its pivotal global Phase 3 trial in EB. 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. 
 
   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)) as an adjunct to diet 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. 
 
   Juxtapid(R)/ Lojuxta(R) (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(R)) and in the EU, Israel and Brazil (under the 
trade name Lojuxta(R)). 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. 
 
   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.  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. 
 
   About Medison 
 
   Medison is one of the world's largest commercial partners of leading 
global biotech companies. Medison is uniquely qualified to provide the 
complete spectrum of integrated services for biotech companies looking 
to enter or expand their presence in Israel, Canada, and Central Eastern 
Europe. Medison runs a corporate venture arm with a dedicated research 
and evaluation team boasting deep scientific and commercial backgrounds. 
Medison also operates a scouting program to cater its partners and is an 
active investor in life science projects around drug development and 
digital health. For more information, visit www.medison.co.il. 
 
   Financial Advisors 
 
   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. 
 
   Forward-Looking Statements 
 
   This press release may contain forward-looking 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. 
 
   Contacts 
 
   Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, 
ir@amrytpharma.com 
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   Edward Mansfield, Shore Capital, NOMAD, +44 (0) 207 468 7906, 
edward.mansfield@shorecap.co.uk 
 
   Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, 
tim@lifesciadvisors.com 
 
   Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700, 
fennell@consilium-comms.com 
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