Evgen Pharma PLC Glioma Orphan Drug designation granted by FDA (5469K)
02 Septiembre 2021 - 5:01AM
UK Regulatory
TIDMEVG
RNS Number : 5469K
Evgen Pharma PLC
02 September 2021
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
+44 (0)7876 741 001 / +44 (0)7980
Anna Dunphy / Paul McManus 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(R),
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/
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END
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September 02, 2021 06:01 ET (10:01 GMT)
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