TIDMAMYT
Amryt Provides Update on Regulatory Review Process for
Oleogel-S10
FDA PDUFA goal date extended by three months to February 28,
2022
EMA CHMP opinion now expected in January 2022
DUBLIN, Ireland, and Boston MA, November 23, 2021, Amryt
(Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage
biopharmaceutical company dedicated to acquiring, developing and
commercializing novel treatments for rare diseases, today announces
that the US Food and Drug Administration ("FDA") has extended the
review period for the New Drug Application ("NDA") for Oleogel-S10
for the treatment of 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.
The FDA extended the Prescription Drug User Fee Act ("PDUFA")
goal date to allow time to review additional analyses of data
previously submitted by Amryt. The submission of this additional
information has been determined by the FDA to constitute a Major
Amendment to the NDA, resulting in an extension of the PDUFA goal
date by three months to February 28, 2022. This is a standard
review extension period to allow the FDA additional time to review
information already submitted by Amryt. At the same time, the FDA
also issued a new Information Request regarding existing study data
in order to continue the FDA's evaluation of Amryt's NDA.
In June 2021, Amryt received confirmation from the FDA that its
NDA for Oleogel-S10 had been accepted and granted priority review.
The PDUFA goal date extension has no impact on the priority review
status of Oleogel-S10.
The European Medicines Agency ("EMA") review process for
Oleogel-S10 in EB is ongoing and Amryt is in the process of
responding to the remaining Major Objections in the List of
Outstanding Issues sent by the EMA. The Committee for Medicinal
Products for Human Use ("CHMP") opinion is now expected in January
2022.
Dr Joe Wiley, CEO of Amryt Pharma, commented: "We are well
positioned to address these regulatory requests from our existing
data within the time periods required and we look forward to our
continued productive discussions as the regulatory agencies
complete their review. If approved, we are confident in the
potential for Oleogel-S10 to be an effective therapy for patients
suffering from this terrible condition and are ready to launch what
will be the first to market novel therapy in EB."
Amryt's previously issued revenue guidance for FY 2021 in the
range of $220M - $225M which represents growth of 20% to 23% on FY
2020 is unaffected by the new regulatory timelines.
About Epidermolysis Bullosa
Epidermolysis Bullosa (EB) is a rare and devastating group of
hereditary disorders of the skin, mucous membranes, and internal
epithelial linings characterized by extreme skin fragility and
blister development. Patients with severe forms of EB suffer from
severe, chronic blistering, ulceration and scarring of the skin,
mutilating scarring of the hands and feet, joint contractures,
strictures of the esophagus and mucous membranes, a high risk of
developing aggressive squamous cell carcinomas, infections and risk
of premature death. The global market opportunity for EB is
estimated by the Company to be in excess of $1.0 billion.
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)); oral 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=wdf6r_y8Ionpq2AP8dKrH051aXI0Rf1SDRVi2uWe8jOQzvWradcj96jsrdM5r3fTs9bb57aOVVPR5FLuo4GuMUu8loyMaKrm8mtrqSk3xkst3K-xHjstACV3SLJOo8dqBkNDtGsYg-LMqHmarguHHGG-05wBrTLMLmaXyQUjy7M=
.
Mycapssa(R) (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(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
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.
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.
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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
and is under review by the FDA and EMA.
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.
This announcement contains inside information for the purposes
of article 7 of the Market Abuse Regulation (EU) 596/2014. The
person making this notification on behalf of Amryt is Rory Nealon,
CFO/COO and Company Secretary.
Financial Advisors
Shore Capital (Daniel Bush, Mark Percy, 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
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Daniel Bush, Shore Capital, NOMAD +44 (0) 207 408 4090,
amrytcorporate@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
November 23, 2021 07:00 ET (12:00 GMT)
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