TIDMAMYT
Amryt Pharma PLC
23 September 2021
Amryt Supports Global FH Awareness Day - September 24, 2021
DUBLIN, Ireland, and Boston MA, September 23, 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 today for Global FH Awareness Day 2021 which will take
place on Thursday, September 24, 2021.
Dr Joe Wiley, CEO of Amryt Pharma, commented: "All of the Amryt
team are pleased to support the great work of the FH Foundation in
the US and FH Europe as they seek to raise awareness of FH and HoFH
amongst patients, clinicians and the wider community. For our part,
we are collaborating with all stakeholders to continue to deliver
therapies to patients in desperate need."
About FH and HoFH
Familial Hypercholesterolaemia ("FH") is an inherited genetic
condition that leads to levels of cholesterol that are much higher
than that of the general population.[i] FH is the most common
genetic condition leading to early heart disease.[ii] Millions of
people around the world do not know that they and their families
are at severe risk for early heart disease, heart attacks, and even
death. Nine out of ten people born today with familial
hypercholesterolemia are undiagnosed. Yet, with early diagnosis and
treatment, individuals diagnosed with FH can reduce their risk for
heart disease by 80%.[iii]
Homozygous Familial Hypercholesterolaemia ("HoFH") is a rare and
severe form of FH, causing excessive levels of low-density
lipoprotein cholesterol ("LDL-C") or 'bad cholesterol' to
accumulate in the body from conception. People with HoFH are at a
continued risk of progressive atherosclerotic disease and
life-threatening cardiac events, for example, heart attack, stroke,
major cardiac surgery and premature cardiac death. Untreated, most
patients with markedly elevated LDL-C levels develop overt
cardiovascular disease before the age of 20 years, and generally do
not survive past 30 years.[iv]
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 has been submitted to 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
[i] https://fheurope.org
[ii] https://rarediseases.info.nih.gov/news/663
[iii]
https://thefhfoundation.org/fh-awareness-day/about-fhad
[iv] Cuchel M, et al. Eur Heart J 2014;35:2146-57
This information is provided by Reach, the non-regulatory press
release distribution service of RNS, part of the London Stock
Exchange. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
Reach is a non-regulatory news service. By using this service an
issuer is confirming that the information contained within this
announcement is of a non-regulatory nature. Reach announcements are
identified with an orange label and the word "Reach" in the source
column of the News Explorer pages of London Stock Exchange's
website so that they are distinguished from the RNS UK regulatory
service. Other vendors subscribing for Reach press releases may use
a different method to distinguish Reach announcements from UK
regulatory news.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
NRABLLFLFKLXBBQ
(END) Dow Jones Newswires
September 23, 2021 06:59 ET (10:59 GMT)
Amryt Pharma (LSE:AMYT)
Gráfico Histórico do Ativo
De Jan 2025 até Fev 2025
Amryt Pharma (LSE:AMYT)
Gráfico Histórico do Ativo
De Fev 2024 até Fev 2025
