7 Nov 2016 07:00
AIM: AMYT
ESM: AYP
Amryt Pharma plc
("Amryt" or the "Company")
FDA Orphan Drug Designation Received
for
Drug Compound with Potential to Treat Acromegaly
Amryt, a clinical-stage specialty pharmaceutical company focused on best-in-class treatments for orphan diseases, is pleased to announce that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to the Company's drug compound, AP102, which has the potential to treat patients with acromegaly. Acromegaly is a rare endocrine disorder in which the body produces excessive growth hormone, leading to abnormal growth throughout the body over time.
The FDA's Orphan Drug Designation program provides orphan status to drugs and biologics that are being developed to address rare diseases or disorders that affect fewer than 200,000 people in the United States. With orphan designation, Amryt qualifies for various incentives, including tax credits for qualified clinical trials and market exclusivity upon regulatory approval.
Joe Wiley, CEO, commented:
"We are pleased that our drug compound, AP102, has received orphan drug designation from the FDA. AP102 has the potential to treat acromegaly, a rare disorder which is estimated to affect four to 13 in every 100,000, and causes excess growth of body tissue.
We believe that AP102 has the potential to improve outcomes for patients facing this debilitating disease and receiving the FDA's orphan drug designation marks an important regulatory milestone for Amryt as we prepare to bring AP102 into the clinic next year."
Enquiries:
Amryt Pharma plc | C/o KTZ Communications |
Joe Wiley, CEO Rory Nealon, CFO/COO |
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Shore Capital | +44 (0) 20 7408 4090 |
Nomad and Joint Broker |
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Bidhi Bhoma, Edward Mansfield |
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Davy | +353 (1) 679 6363 |
ESM Adviser and Joint Broker |
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John Frain, Anthony Farrell |
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Stifel | +44 (0) 20 7710 7600 |
Joint Broker |
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Jonathan Senior, Ben Maddison |
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KTZ Communications | +44 (0) 20 3178 6378 |
Katie Tzouliadis |
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About Acromegaly
Acromegaly is a rare endocrine disorder that most commonly results from an adenoma, a benign tumour of the pituitary gland that secretes excessive growth hormone (GH) and leads to excess production of the hormone IGF-1. The progression of acromegaly is typically slow and diagnosis is often delayed by years. As the disease advances, patients typically exhibit abnormal growth throughout the body.
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.
Amryt's lead product, Episalvan, received marketing approval for the treatment of partial-thickness wounds from the European Commission in January 2016. Amryt intends to further develop 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. Amryt is currently planning a phase III study of Episalvan in EB, which has been granted US and EU orphan drug designation. The market opportunity for EB is estimated to be circa US$1.5 billion.
Amryt's earlier stage products are 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. These include acromegaly and Cushing's disease.
The Company joined AIM and Dublin's ESM in April 2016 following the reverse takeover of Fastnet Equity PLC.