Amryt Pharma PLC Lojuxta to be reimbursed in France (2678E)
October 17 2018 - 2:00AM
UK Regulatory
TIDMAMYT
RNS Number : 2678E
Amryt Pharma PLC
17 October 2018
17 October 2018
AIM: AMYT
ESM: AYP
Amryt Pharma plc
("Amryt" or the "Company")
Lojuxta to be reimbursed in France
Amryt's lead commercial product now available in all five of the
EU's largest markets
Amryt, a revenue generating orphan drug company focused on
acquiring, developing & commercialising products that help
improve the lives of patients where there is a high unmet medical
need, is pleased to announce that it has reached agreement with
France's CEPS (Comité économique des produits de santé), to
reimburse Lojuxta(R) (lomitapide) for the treatment of adult
patients with Homozygous Familial Hypercholesterolaemia ("HoFH") in
France.
From the first quarter of 2019, adult HoFH patients suffering
with this ultra-rare, life-threatening genetic condition can
receive a 'first in class' medicine to reduce low density
lipoprotein (LDL) cholesterol, often referred to as 'bad
cholesterol', when used as an adjunctive therapy to other lipid
lowering medications and where available, apheresis. The clinical
value of Lojuxta in managing adult HoFH has been demonstrated in
clinical trials and in the real world (see previously announced
study results on Amryt's website, here).
This approval now means that Lojuxta is available across all
five of the EU's major markets (France, the UK, Italy, Germany and
Spain), either by responding to named patient requests or on a
fully reimbursed basis and is in line with Amryt's strategy to make
Lojuxta available to more patients across Amryt's licensed
territories.
Joe Wiley, CEO of Amryt Pharma, commented: "A clear aim in
continuing the positive momentum in Lojuxta revenues is to ensure
reimbursement in our core territories. Following closely on from
our recent approval with the NHS in England, where we have already
started treating patients, we are now very pleased to be able to
make Lojuxta available to adult HoFH patients in France."
- Ends -
Enquiries:
Amryt Pharma plc +353 (1) 518 0200
Joe Wiley, CEO
Rory Nealon, CFO/COO
Stifel +44 (0) 20 7710 7600
Joint Broker
Jonathan Senior, Ben Maddison
Shore Capital +44 (0) 20 7408 4090
NOMAD and Joint Broker
Edward Mansfield, Mark Percy, Daniel
Bush
Davy +353 (1) 679 6363
ESM Adviser and Joint Broker
John Frain, Anthony Farrell
Consilium Strategic Communications +44 (0) 20 3709 5700
Amber Fennell, David Daley, Matthew
Neal
About Amryt
Amryt is a revenue generating orphan drug company focused on
acquiring, developing & commercialising products that help
improve the lives of patients where there is a high unmet medical
need.
Lojuxta is an approved treatment for adult patients with the
rare cholesterol disorder - Homozygous Familial
Hypercholesterolaemia ("HoFH"). This disorder 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 narrowing and blocking of blood vessels,
heart attacks and strokes, even at a very young age if not properly
diagnosed or receiving adequate treatment. Lojuxta is indicated as
an adjunct to a low-fat diet and other lipid-lowering medicinal
products with or without LDL apheresis in adult patients with
HoFH.
Amryt holds an exclusive licence to sell Lojuxta (lomitapide)
across the European Economic Area, Middle East and North Africa,
Switzerland, Turkey, Israel, Russia, the Commonwealth of
Independent States and the non-EU Balkan states.
Amryt's lead drug candidate, AP101, is a potential treatment for
Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin
disorder affecting young children for which there is currently no
treatment. It is currently in Phase 3 clinical trials. The European
and US market opportunity for EB is estimated to be in excess of
EUR1 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.
In March 2018, Amryt in-licensed a pre-clinical gene-therapy
platform technology, AP103, which offers a potential treatment for
patients with Recessive Dystrophic Epidermolysis Bullosa, a subset
of EB, and is also potentially relevant to other genetic
disorders.
For more information on Amryt, please visit amrytpharma.com
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END
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