The Company

Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases.

OUR ASSETS

The Company has a number of assets that are potential near-term value drivers

LOJUXTA®▼, JUXTAPID®. (lomitapide) capsules
Lomitapide is approved in the EU, under the brand name LOJUXTA®, for the treatment of adult patients with Homozygous Familial Hypercholesterolaemia (HoFH). Lomitapide is approved, under the brand name JUXTAPID®, in US, Argentina, Canada, Colombia, Japan and a limited number of other countries. In the US, it is approved as an adjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein to reduce low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B and non-high-density lipoprotein cholesterol in adult patients with HoFH.

HoFH is a disorder that impairs the body’s ability to remove low density lipoprotein (LDL)  “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 with HoFH – and subsequent aggressive and premature narrowing and blocking of blood vessels.

See the LOJUXTA® Summary of Product Characteristics (EU audiences only) or JUXTAPID® Medication Guide (US audiences only)for further information.

MYALEPTA®, MYALEPT® (metreleptin) for injection – Metreleptin is approved in the EU, under the brand name MYALEPTA®, as a treatment for leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above, and familial or acquired PL in adults and children 12 or over for whom standard treatments have failed to achieve adequate metabolic control. See Myaleptainfo.eu/ for more information (EU audiences only).

Metreleptin is marketed in the US under the brand name MYALEPT®. It is approved in the US as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired GL. See Myalept Medication Guide for more information (US audiences only)

Lipodystrophy is a condition caused by uncontrolled loss of fat tissue, leading to leptin deficiency and is associated with metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.

Oleogel-S10 (AP101) – Amryt’s lead development candidate, Oleogel-S10, is a potential treatment for Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no treatment available. Oleogel-S10 is currently in a Phase 3 clinical trial and recently reported positive unblinded interim efficacy analysis.  It is anticipated this study will be fully enrolled by the end of H2 2019. The European and US market opportunity for EB is estimated to be in excess of $1 billion.

AP103 Gene Therapy
– In March 2018, Amryt in-licenced a pre-clinical non-viral gene-therapy platform technology from University College Dublin. AP103, which is based on this technology platform, offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB.  This gene-therapy platform also has potential applicability across a range of other genetic disorders.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Reporting forms and information can be found on the MHRA Yellow Card reporting site.
Adverse events should also be reported to Amryt Pharmaceuticals DAC on:
Tel: +44 1604 549 952 or Freephone Number +800 4447 4447
E-mail: medinfo@amrytpharma.com