GlobeNewswire Inc | Jan 18, 2022 07:00AM EST

January 18, 2022

Amryt Announces New Patents for Oleogel-S10

DUBLIN, Ireland, and Boston MA, January 18, 2022Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases,announces an update regarding the patents for its lead development candidate, Oleogel-S10.

Oleogel-S10The United States Patent and Trademark Office (USPTO) has issued to Amryt a notice of allowance for US Patent Application No. 17/393,171 Betulin-Containing Birch Bark Extracts and their Formulation with claims covering the Oleogel-S10 formulation. If Oleogel-S10 is approved by the FDA, the resulting patent will be listable in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by theUnited States Food and Drug Administration (FDA) and this patent will expire in January 2039.Together with four previously granted patents, if Oleogel-S10 is approved, Amryt will have 5 Orange Book-listed patents for Oleogel-S10 with patent protection throughJanuary 2039, without patent term extension.

Dr Joe Wiley, CEO of Amryt Pharma, commented:We are always working to develop and extend our IP portfolio and todays news further illustrates the robust IP protection enjoyed by our lead development asset, Oleogel-S10.Oleogel-S10 is a potential treatmentfor the cutaneous manifestations of Junctional and DystrophicEpidermolysis Bullosa(EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.

About AmrytAmryt 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.

Amryts commercial business comprises three orphan disease products metreleptin (Myalept/ Myalepta); oral octreotide (Mycapssa); and lomitapide (Juxtapid/ Lojuxta).

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) as an adjunct to diet for thetreatment 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 thislink.

Mycapssa (oral octreotide) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.Mycapssa is the first and only oralsomatostatin analogapproved by the FDA.Mycapssa has also been submitted to the EMA and is not yet approved in Europe.For additional information, please follow thislink.

Juxtapid/Lojuxta (lomitapide) is approvedas 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) and in the EU, Israel, Saudi Arabia and Brazil (under the tradename Lojuxta).For additional information, please follow thislink.

Amryt'slead developmentcandidate,Oleogel-S10 (Filsuvez)is a potential treatment for the cutaneous manifestations of Junctional and DystrophicEpidermolysis Bullosa(EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.Filsuvez has been selected asthe brand name forOleogel-S10.The product does not currently have regulatory approval to treat EB and is under review by the FDA and EMA.

Amryts pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, andthe polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders.

Amryt alsointends to develop oral medications that are currently only available as injectable therapies through itsTransient PermeabilityEnhancer (TPE) technology platform.For more information on Amryt, including products, please visitwww.amrytpharma.com.

Forward-Looking StatementsThis announcementmay contain forward-looking statements and 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 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 Companys 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

Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com