TIDMAMYT
RNS Number : 9696T
Amryt Pharma PLC
09 July 2018
9 July 2018
AIM: AMYT
Amryt Pharma plc
("Amryt" or the "Company")
NHS England approves funding for Lojuxta
Amryt, a biopharmaceutical company focused on rare and orphan
diseases, is pleased to announce that Lojuxta(R) (lomitapide) has
been approved for funding as an NHS treatment for adult patients
with Homozygous Familial Hypercholesterolaemia ("HoFH") in
England.
The decision means that, from this year, patients with this
ultra-rare, life-threatening genetic condition being treated on the
NHS in England can be prescribed a 'first in class' medicine able
to reduce the production and uptake of 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).
Lojuxta delivers significant reductions in LDL cholesterol,
enabling patients to reach target levels of cholesterol that they
have not otherwise been able to reach. The Company believes that
this outcome is a vital step in helping adults with HoFH across
England, who are in urgent need of alternative treatment options,
receive a better standard of care and has the potential to
transform their lives with one simple capsule a day.
The Company expects Lojuxta to be available to HoFH patients
treated by NHS England during the fourth quarter of 2018.
Joe Wiley, CEO of Amryt Pharma, commented:
"We are delighted that NHS England has recognised the
significant unmet need in the current treatment of HoFH in England
and the potential Lojuxta has to significantly improve the lives of
HoFH patients. Lojuxta has been shown to be an effective adjunctive
treatment for adult HoFH patients and has enabled many patients to
achieve the recommended target levels of cholesterol for the first
time, even stopping apheresis in some cases.
"This decision today is in line with our strategy to make
Lojuxta available to more patients across Amryt's territories and
it is estimated that funding approval will have a positive impact
on revenue from 2019 and beyond. We look forward to working with
the NHS to make this treatment available to patients in need of
this life changing therapy as soon as possible."
Dr Handrean Soran, Consultant Physician & Endocrinologist at
Manchester University Hospital NHS Foundation Trust, added:
"NHS England's decision is a vital step in ensuring patients
with HoFH have access to a new effective treatment option.
Lomitapide works differently to other available medicines for this
condition. Unlike currently available treatments, lomitapide lowers
cholesterol in adults with HoFH by switching off the release of
'bad cholesterol' from the liver and reduces the uptake from the
gut. The treatment has been shown it can enable more than half of
adults with this life-threatening condition to finally be able to
reach target cholesterol levels, previously thought not to be
possible with current available therapies, and to substantially
reduce their need for lipoprotein apheresis, a lengthy and
cumbersome 'dialysis for cholesterol', available only in six
specialist centres in the UK. This is very encouraging news for
patients, their families and clinicians."
- 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
Davy +353 (1) 679 6363
ESM Adviser and Joint Broker
John Frain, Anthony Farrell
Shore Capital +44 (0) 20 7408 4090
NOMAD and Joint Broker
Edward Mansfield, Mark Percy, Daniel
Bush
Consilium Strategic Communications +44 (0) 20 3709 5700
Amber Fennell, Matthew Neal, Nicholas
Brown
About Amryt
Amryt is a biopharmaceutical company focused on developing and
delivering innovative new treatments to help improve the lives of
patients with rare or orphan diseases.
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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