TIDMAMYT
Amryt Virtual Capital Markets Event - September 13, 2021 --
1000-1200 EDT
DUBLIN, Ireland, and Boston MA, August 9, 2021, Amryt (Nasdaq:
AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical
company dedicated to acquiring, developing and commercializing
novel treatments for rare diseases, will host a Virtual Capital
Markets Event for Analysts and Investors on Monday, September 13,
2021, from 1000 -- 1200 (EDT).
Presentations will include an update on Amryt's long-term
strategy, the global market opportunity for Amryt's three
commercial products and Amryt's growth plans for Mycapssa(R) post
its recent acquisition of Chiasma, Inc. Mycapssa(R) is the first
and only FDA-approved oral somatostatin analog (SSA) for acromegaly
patients who have responded to and tolerated treatment with
octreotide or lanreotide. Mycapssa(R) also has the potential to
expand into the neuroendocrine tumor (NET) market and has a
confirmed modified 505(b)(2) regulatory pathway.
Leading KOL, Dr. Maria Fleseriu, FACE (Oregon Health &
Science University) will join the event to discuss the current
treatment landscape in acromegaly.
Amryt management will also provide an update on their lead
development candidate, Oleogel-S10, including a discussion on the
regulatory pathway for Oleogel-S10 and their global
commercialization and launch readiness plans for Oleogel-S10, if
approved. Oleogel-S10 is a potential treatment for Epidermolysis
Bullosa (EB), for which there is currently no approved
treatment.
A question and answer session will follow the presentations.
Registration
To register for the event, please go to:
https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MTM1Mw==
A detailed schedule will be sent to those registered before the
event.
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
https://www.globenewswire.com/Tracker?data=ryy3aL9-rymARzhp2XCVQw8RNHea8ELTWH8MJ9ZIjOdGywRC0RvBzVZ25qBo-jWZlDB8E0NfcZ326qJe13hQ1eUsKiMtyW6rKCf5zfw60PehZRDp1U8jxRd89mY9mPNQgTkwq72kt3V8QO1yAtqBgNhWhzGax5rIagzNECFec0M=
.
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
https://www.globenewswire.com/Tracker?data=ryy3aL9-rymARzhp2XCVQ__Ezz4zre7YG814sNE89prS238mXySNSeQpIx-h8Rkd5ZM595BCumJqXBZMPriK9A==
.
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
https://www.globenewswire.com/Tracker?data=ryy3aL9-rymARzhp2XCVQ6DhQFOg3_BwEWMfxp6VTIs6XJDUaR4uuTvLhXBeCB9ov7rFyYVXMUsyNwLGLubK2TTB51TnNYaLi_8QCbIKimg=
.
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.
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 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,
ir@amrytpharma.com
https://www.globenewswire.com/Tracker?data=YEQ_8SAb9j-ZPQHZwJO2gRBwe5y9KP6bEsntZEjURVZ3wKE098FrZy90iy_BLh1pFE3PRh0i3_Nbg2BjE7mtaxFWnSF8RIyJlAM6SFrKEis=
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, fennell@consilium-comms.com
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(END) Dow Jones Newswires
August 09, 2021 07:00 ET (11:00 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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