TIDMAMYT
Amryt Pharma PLC
22 October 2021
Amryt Supports Global EB Awareness Week 2021
DUBLIN, Ireland, and Boston MA, October 22, 2021, Amryt (Nasdaq:
AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical
company dedicated to acquiring, developing and commercializing
novel treatments for rare diseases, announces its support for
Global Epidermolysis Bullosa (EB) Awareness Week which is taking
place October 25 - 31, 2021 .
Dr Joe Wiley, CEO of Amryt Pharma, commented: "Epidermolysis
Bullosa is a very distressing condition which severely impacts the
lives of those living with EB and also has a profound impact on
parents, families and all those involved in their care. The current
treatment paradigm focuses on wound care and dressing changes which
can take several hours each day and can be extremely painful, often
requiring the use of prescription pain medication. Our mission at
Amryt is to transform the lives of people affected by rare,
debilitating conditions by providing innovative medicines that
bring hope to those in greatest need and if approved, we aim to
bring the first approved treatment to the EB community in the near
future. EB Awareness Week is a great opportunity to show our
support for all those living with EB and to raise awareness of this
truly horrendous 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 three orphan disease
products - metreleptin (Myalept(R)/ Myalepta(R)); octreotide
(Mycapssa(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 link .
Mycapssa(R) (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(R)
is the first and only oral somatostatin analog approved by the FDA.
Mycapssa(R) has also been submitted to the EMA for regulatory
approval. For additional information, please follow this link .
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, 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 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
but has been submitted to the FDA for approval and in June 2021,
Amryt received confirmation from the FDA that its NDA for
Oleogel-S10 had been accepted and granted priority review. The FDA
also set a target PDUFA date of November 30, 2021. In Europe, a MAA
for Oleogel-S10 was accepted for assessment by the EMA in March
2021.
Amryt's pre-clinical gene therapy candidate, AP103, offers a
potential treatment for patients with Dystrophic EB, and the
polymer-based delivery platform has the potential to be developed
for the treatment of other genetic disorders.
Amryt also intends to develop oral medications that are
currently only available as injectable therapies through its
Transient Permeability Enhancer (TPE(R) ) technology platform. For
more information on Amryt, including products, please visit
www.amrytpharma.com .
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 announcement may 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 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
Edward Mansfield, Shore Capital, NOMAD +44 (0) 207 408 4090,
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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