Amryt Pharma PLC Orphan drug designation for Acromegaly Compound (4378O)
November 07 2016 - 1:00AM
UK Regulatory
TIDMAMYT
RNS Number : 4378O
Amryt Pharma PLC
07 November 2016
AIM: AMYT
ESM: AYP
Amryt Pharma plc
("Amryt" or the "Company")
FDA Orphan Drug Designation Received
for
Drug Compound with Potential to Treat Acromegaly
Amryt, a clinical-stage specialty pharmaceutical company focused
on best-in-class treatments for orphan diseases, is pleased to
announce that the U.S. Food and Drug Administration ("FDA") has
granted orphan drug designation to the Company's drug compound,
AP102, which has the potential to treat patients with acromegaly.
Acromegaly is a rare endocrine disorder in which the body produces
excessive growth hormone, leading to abnormal growth throughout the
body over time.
The FDA's Orphan Drug Designation program provides orphan status
to drugs and biologics that are being developed to address rare
diseases or disorders that affect fewer than 200,000 people in the
United States. With orphan designation, Amryt qualifies for various
incentives, including tax credits for qualified clinical trials and
market exclusivity upon regulatory approval.
Joe Wiley, CEO, commented:
"We are pleased that our drug compound, AP102, has received
orphan drug designation from the FDA. AP102 has the potential to
treat acromegaly, a rare disorder which is estimated to affect four
to 13 in every 100,000, and causes excess growth of body
tissue.
We believe that AP102 has the potential to improve outcomes for
patients facing this debilitating disease and receiving the FDA's
orphan drug designation marks an important regulatory milestone for
Amryt as we prepare to bring AP102 into the clinic next year."
Enquiries:
Amryt Pharma plc C/o KTZ Communications
Joe Wiley, CEO
Rory Nealon, CFO/COO
+44 (0) 20 7408
Shore Capital 4090
Nomad and Joint Broker
Bidhi Bhoma, Edward Mansfield
Davy +353 (1) 679 6363
ESM Adviser and Joint Broker
John Frain, Anthony Farrell
+44 (0) 20 7710
Stifel 7600
Joint Broker
Jonathan Senior, Ben Maddison
+44 (0) 20 3178
KTZ Communications 6378
Katie Tzouliadis
About Acromegaly
Acromegaly is a rare endocrine disorder that most commonly
results from an adenoma, a benign tumour of the pituitary gland
that secretes excessive growth hormone (GH) and leads to excess
production of the hormone IGF-1. The progression of acromegaly is
typically slow and diagnosis is often delayed by years. As the
disease advances, patients typically exhibit abnormal growth
throughout the body.
About Amryt Pharma plc - see www.amrytpharma.com
Amryt Pharma is a specialty pharmaceutical company focused on
developing and delivering innovative new treatments to help improve
the lives of patients with rare or 'orphan' diseases. The Company
is building a diversified portfolio of commercially attractive,
best-in-class, proprietary new drugs to help address some of these
rare and debilitating illnesses for which there are currently no
available treatments.
Amryt's lead product, Episalvan, received marketing approval for
the treatment of partial-thickness wounds from the European
Commission in January 2016. Amryt intends to further develop
Episalvan as a new treatment for Epidermolysis Bullosa ("EB"), a
rare and distressing genetic skin disorder affecting young children
for which there is currently no treatment. Amryt is currently
planning a phase III study of Episalvan in EB, which has been
granted US and EU orphan drug designation. The market opportunity
for EB is estimated to be circa US$1.5 billion.
Amryt's earlier stage products are focused on developing novel,
next generation somatostatin analogue ("SSA") peptide medicines for
patients with rare neuroendocrine diseases, where there is a high
unmet medical need. These include acromegaly and Cushing's
disease.
The Company joined AIM and Dublin's ESM in April 2016 following
the reverse takeover of Fastnet Equity PLC.
This information is provided by RNS
The company news service from the London Stock Exchange
END
REAFSFFAMFMSEFF
(END) Dow Jones Newswires
November 07, 2016 02:00 ET (07:00 GMT)
Amryt Pharma (LSE:AMYT)
Historical Stock Chart
From Apr 2024 to May 2024
Amryt Pharma (LSE:AMYT)
Historical Stock Chart
From May 2023 to May 2024