AMYT Amryt Pharma Plc

 
TIDMAMYT 
 
 
 
   Amryt Announces FDA Acceptance of New Drug Application for Oleogel-S10 
for the Treatment of Epidermolysis Bullosa 
 
   DUBLIN, Ireland, and Boston MA, June 2, 2021, Amryt (Nasdaq: AMYT, AIM: 
AMYT), a global, commercial-stage biopharmaceutical company dedicated to 
acquiring, developing and commercializing novel treatments for rare 
diseases, today announces that the U.S. Food and Drug Administration 
("FDA") has accepted for filing Amryt's New Drug Application ("NDA") for 
Oleogel-S10 for the treatment of Epidermolysis Bullosa ("EB"). 
Oleogel-S10 is a potential treatment for the cutaneous manifestations of 
Junctional and Dystrophic EB, a rare and distressing genetic skin 
disorder affecting young children and adults for which there is 
currently no approved treatment. 
 
   The FDA has informed Amryt that notification of any filing review issues, 
including priority review determination and the Prescription Drug User 
Fee Act ("PDUFA") target action date for the NDA will be provided by 
June 12, 2021 (Day 74 post submission date). 
 
   The NDA is supported by positive results from Amryt's pivotal global 
Phase 3 trial in EB ("EASE") reported in September, 2020.  EASE was the 
largest ever global Phase 3 study conducted in patients with EB and is 
the first Phase 3 trial ever to demonstrate positive results in EB. 
 
   Joe Wiley, CEO of Amryt Pharma, commented: "We are very pleased with the 
FDA's acceptance of our NDA for Oleogel-S10 as a potential treatment for 
EB and we look forward to continuing to work closely with the FDA 
throughout the review process. Today's news is also significant for 
patients.  If approved, Oleogel-S10 could potentially be an important 
treatment option for those suffering from this devastating condition." 
 
   About Amryt 
 
   Amryt is a global commercial-stage biopharmaceutical company focused on 
acquiring, developing and commercializing innovative 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 -- 
metreleptin (Myalept(R)/ Myalepta(R)) and lomitapide (Juxtapid(R)/ 
Lojuxta(R)). 
 
   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.  For additional information, please follow this 
https://www.globenewswire.com/Tracker?data=n2mgutjiVwD9jrov5ojXSYgiTQqppJfC3aal9RG6iOBwnxamC5VMSJbgCPS-k8OQid86YKqvtcMfHTLvpy7Ar-_TEQemCBicaZHAxRxFc6zpvL8IdBCDD1MviSCzFc0E1tVgi_0tPVEQIfjgIJ0rEJZsmrfQrRi6LFRtQrFxFDg= 
link. 
 
   Juxtapid(R)/Lojuxta(R) (lomitapide) is approved as an adjunct to a 
low-fat diet and other lipid-lowering medicinal productsfor adults with 
the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia 
("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the 
trade name Juxtapid(R)) and in the EU, Israel and Brazil (under the 
trade name Lojuxta(R)). For additional information, please follow this 
https://www.globenewswire.com/Tracker?data=n2mgutjiVwD9jrov5ojXSWseOrIR5BdX4Fvg2DnFXic7T07KurRulAE2MZ7pelB6fcc6WEn8nMa6b_vOTpkfW_-19EnVW-Ib_zHLJJPlhJQ= 
link. 
 
   Amryt's lead development candidate, Oleogel-S10 (Filsuvez(R)) is a 
potential treatment for the cutaneous manifestations of Junctional and 
Dystrophic 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 Oleogel-S10. The product does not currently have 
regulatory approval to treat EB. 
 
   Amryt's pre-clinical gene therapy platform, AP103, offers a potential 
treatment for patients with Dystrophic EB, and is also potentially 
relevant to other genetic disorders. 
 
   For more information on Amryt, including products, please visit 
https://www.globenewswire.com/Tracker?data=_UY2YETJQg4d_qCwBjZ4A0kBD2nxx5Ec-RFQDDFSmv-7ngLC9Ilu2QoQCcUCiYJS1KDlAqvirhUrHRtHaLQkjUBZrelMUaJaBr3zoTVQiOY= 
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. 
 
   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. 
 
   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, 
https://www.globenewswire.com/Tracker?data=Os-bhxoGvx-vgvrGKef01UwgcbwVsDIhs2NoADgyhdfD1eJcKSGL7f7O1koN8R7ZDX4QLmpQzDLcR4_-9BwkEkQD52U3kG7Se8efgbTPZaE= 
ir@amrytpharma.com 
 
   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 
 
 
 
 
 
 

(END) Dow Jones Newswires

June 02, 2021 08:30 ET (12:30 GMT)

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