TIDMAMYT
Amryt Pharma PLC
23 September 2020
AMRYT PHARMA PLC
("Amryt" or the "Company")
AMRYT SUPPORTS GLOBAL FH AWARENESS DAY - SEPTEMBER 24, 2020
DUBLIN, Ireland, and Boston MA, September 23 2020, Amryt
(Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage
biopharmaceutical company dedicated to developing and
commercializing novel therapeutics to treat patients suffering from
serious and life-threatening rare diseases , announces its support
today for Global FH Awareness Day 2020 which will take place on
Thursday, September 24, 2020.
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".
Magdalena Daccord, CEO of FH Europe, commented: "FH Awareness
Day in year 2020 is not just another awareness campaign aimed at
making as much noise as possible. It is an absolute opportunity and
a necessity to make common Familial Hypercholesterolemia (FH) and
its severe and rare form, Homozygous FH, a public health priority.
The Global Call to Action on FH equips us with 9 actionable
recommendations to make it happen. The COVID pandemic, on the other
hand, highlights the urgency and the gravity of the inherited high
cholesterol directly impacting over 30 million people
worldwide...starting from birth. #FHaware2020 is the time to come
together and make seriously good things happen!".
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]
Amryt Pharma plc +353 (1) 518 0200
Joe Wiley, CEO
Rory Nealon, CFO/COO
LifeSci Advisors, LLC +1 (212) 915 2564
Tim McCarthy
Consilium Strategic Communications +44 (0) 20 3709 5700
Amber Fennell, Matthew Neal, Ashley Tapp
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.
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 (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.
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)) 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.
Amryt's lead development candidate, FILSUVEZ (R) is a potential
treatment for the cutaneous manifestations of EB, a rare and
distressing genetic skin disorder affecting young children and
adults for which there is currently no approved treatment. In
September 2020, Amryt reported positive top line results from its
pivotal global phase 3 trial of FILSUVEZ(R) in EB. The primary
endpoint of the trial was met (p-value = 0.013). FILSUVEZ (R) has
been granted Rare Pediatric Disease Designation and has also
received a Fast Track Designation from the U.S. Food and Drug
Administration. The global market opportunity for EB is estimated
by the Company to be in excess of $1.0 billion.
In March 2018, Amryt in-licenced a preclinical 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 .
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
Statements in this announcement with respect to Amryt's
business, strategies, timing for completion of and announcing
results from the EASE trial, the potential impact of closing
enrollment in the EASE trial, as well as other statements that are
not historical facts are forward-looking statements involving risks
and uncertainties which could cause the actual results to differ
materially from such statements. 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.
[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
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