Amryt Pharma PLC Grant of patent in Japan for AP101 (Episalvan) (1687W)
February 07 2017 - 1:00AM
UK Regulatory
TIDMAMYT
RNS Number : 1687W
Amryt Pharma PLC
07 February 2017
AIM: AMYT, ESM: AYP
Amryt Pharma plc
("Amryt" or the "Company")
Grant of patent in Japan for lead drug candidate, AP101
(Episalvan)
for Treatment of Epidermolysis Bullosa
Amryt, the pharmaceutical company focused on best-in-class
treatments for rare and orphan diseases, is pleased to announce
that it has been granted a patent in Japan by the Japanese Patent
Office for its lead drug candidate, AP101 (Episalvan), for the
treatment of Epidermolysis Bullosa ("EB"), a rare genetic skin
disorder which causes exceptionally fragile skin.
Amryt expects AP101 (Episalvan), which has already successfully
demonstrated accelerated healing in partial thickness wounds
compared to standard therapy, to enter a pivotal Phase 3 clinical
trial in late Q1 2017. The patent grant for AP101 (Episalvan) in
Japan follows similar grants secured in the US in September 2016
and in Europe in March 2016 as well as other patent grants in other
territories, including Canada and Australia. The global EB market
is estimated to be worth c. EUR 1.3 billion per annum.
EB is a chronic and debilitating condition for which there is
currently no known cure. Those born with the disorder are often
referred to as 'butterfly children' reflecting the extremely
fragile nature of their skin. There are approximately 500,000
people living with EB worldwide, with some 35,000 in Europe and
30,000 in the US.
Joe Wiley, Chief Executive Officer of Amryt, commented:
"We are delighted to announce that AP101 (Episalvan) has been
granted a patent in Japan for the treatment of EB, widening the
scope of our potential marketplace. It follows similar patent
grants in the US and Europe as well as other territories which we
have secured over the past 10 months or so.
EB is a rare and potentially disfiguring hereditary skin
disorder with no available treatment option today. There are
approximately 30,000 patients in the US and 35,000 patients in
Europe and we believe that our product, AP101 (Episalvan), could
potentially offer a compelling therapy in this disease. We are
preparing for and look forward to starting our pivotal Phase 3
clinical trial over the coming months."
Enquiries:
c/o KTZ Communications
Amryt Pharma plc +44 (0)20 3178 6378
Joe Wiley, CEO
Rory Nealon, CFO/COO
Shore Capital +44 (0) 20 7408 4090
Nomad and Joint Broker
Bidhi Bhoma, Edward Mansfield
Davy +353 (1) 679 6363
ESM Adviser and Joint Broker
John Frain, Anthony Farrell
Stifel +44 (0) 20 7710 7600
Joint Broker
Jonathan Senior, Ben Maddison
KTZ Communications +44 (0) 20 3178 6378
Katie Tzouliadis, Emma Pearson
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.
It recently acquired an exclusive licence to sell LOJUXTA
(lomitapide), across the EU and other territories including the
Middle East, North Africa, Turkey and Israel. LOJUXTA is used to
treat a rare life-threatening disease called Homozygous Familial
Hypercholesterolemia.
Amryt's lead development product, AP101 (Episalvan), received
marketing approval for the treatment of partial-thickness wounds
from the European Commission in January 2016. Amryt intends to
develop AP101 (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.
The Company is currently planning a Phase 3 study of AP101
(Episalvan) in EB, which has been granted US and EU orphan drug
designation. The market opportunity for EB is estimated to be circa
EUR 1.3 billion.
Amryt's earlier stage product AP102 is 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, including acromegaly and
Cushing's disease. AP102 was recently granted orphan designation in
the US in acromegaly by the FDA.
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
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