Amryt Pharma PLC: Notice of Trading Update

Amryt Pharma

4 November 2019
AIM: AMYT
Euronext Growth: AYP

AMRYT PHARMA PLC

(“Amryt” or the “Company”)

Notice of Trading Update

Amryt, a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases, will announce a trading update for the nine-months ended 30 September 2019 on Tuesday, 5 November 2019.

Enquiries:

Amryt Pharma plc

+353 (1) 518 0200

Joe Wiley, CEO

Rory Nealon, CFO/COO

 

Shore Capital

+44 (0) 20 7408 4090

NOMAD and Joint Broker

 

Edward Mansfield, Mark Percy, Daniel Bush, John More

 

Stifel

+44 (0) 20 7710 7600

Joint Broker

 

Jonathan Senior, Ben Maddison

 

Davy

+353 (1) 679 6363

ESM Adviser and Joint Broker

 

John Frain, Daragh O’Reilly

 

Consilium Strategic Communications

+44 (0) 20 3709 5700

Amber Fennell, Matthew Neal, Nicholas Brown

 

LifeSci Advisors, LLC

+1 (212) 915 2564

Tim McCarthy

 

About Amryt

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. Amryt comprises a strong and growing portfolio of commercial and development assets.

Amryt’s commercial business comprises two orphan disease products.

Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan (under the trade name, Juxtapid®) and in the EU (under the trade name, Lojuxta®). HoFH is a rare genetic disorder which 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 cardiovascular disease.

Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name, Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name, Myalepta®) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 or over for whom standard treatments have failed to achieve adequate metabolic control. Metreleptin is also approved for lipodystrophy in Japan. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.

Amryt's lead development candidate, AP101 (Oleogel-S10), is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. It is currently being studied in a Phase 3 clinical trial and recently reported that unblinded interim efficacy data supported continuation of the study with a modest increase in sample size and unblinded interim safety data allowed the inclusion of children from as young as 21 days old. AP101 has been granted FDA Pediatric Rare Disease Designation and has also received a Fast Track Designation from the FDA. The European and US market opportunity for EB is estimated by the Directors to be in excess of $1 billion.

In March 2018, Amryt in-licenced 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, including products, please visit www.amrytpharma.com

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