2 Sep 2021 11:01
Evgen Pharma plc
("Evgen" or the "Company")
Glioma Orphan Drug designation for SFX-01 granted by FDA
Evgen Pharma plc (AIM: EVG), a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases, announces the grant of an Orphan Drug Designation ("OD") by the US Food and Drug Administration (''FDA'') for use of SFX-01 to treat malignant glioma.
The Company, announced submission of an Orphan Drug application to the FDA on 13 July 2021. OD is usually granted when there are fewer than 200,000 patients with a given disease in the United States and there is a scientific rationale for potential use of the product in that condition. As well as recognising the relative rareness of a disease, OD confers intellectual property cover to an investigational drug in the form of data protection at the time of approval of a new drug application, which is additional to any patent cover in force. Tax credits are also possible on eventual US sales of an approved orphan drug.
Dr Huw Jones, CEO of Evgen, commented: "We are delighted that our team and advisors have successfully gained Orphan Drug designation for SFX-01 in the USA in a very short period of time. This is part of a wider strategy to access the US market and positions us well for further investigations of our lead asset in this devastating brain cancer as we continue to optimize SFX-01 for clinical trials and eventually partnering.''
The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.
Enquiries:
Evgen Pharma plc www.evgen.com | via Walbrook | |
Dr Huw Jones, CEO | ||
Richard Moulson, CFO | ||
finnCap www.finncap.com | +44 (0)20 7220 0500 | |
Geoff Nash / Teddy Whiley (Corporate Finance) | ||
Alice Lane (ECM) | ||
Walbrook PR | +44 (0)20 7933 87870 or evgen@walbrookpr.com | |
Anna Dunphy / Paul McManus | +44 (0)7876 741 001 / +44 (0)7980 541 893 | |
About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.
Clinical data from the Company's open-label Phase II STEM trial has shown that SFX-01 can halt the growth of progressing tumours in patients with oestrogen-positive (ER+) metastatic breast cancer, and in some cases significantly shrink the tumour, whilst causing very few side effects.
The has its headquarters at Alderley Park, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol EVG.
For further information, please visit: www.evgen.com
For research on the Company, please visit: http://evgen.com/investors/analyst-coverage/