REG - Futura Medical PLC - MED3000 Granted US FDA Approval for OTC Sale

Futura MedicalAnnouncement

12/06/2023 07:00

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RNS Number : 3215C  Futura Medical PLC  12 June 2023

 

12 June 2023

 Futura Medical plc

("Futura" or the "Company")

Futura's Fast-Acting Topical Gel for the Treatment of Erectile Dysfunction
Granted Marketing Authorisation by the US FDA for Over the Counter Sale

Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical
company developing a portfolio of innovative products based on its
proprietary, transdermal DermaSys® drug delivery technology currently focused
on sexual health, today announces that the US Food and Drug Administration
("FDA") has granted over the counter sale ("OTC") Marketing Authorisation for
MED3000, the Company's breakthrough, topical gel formulation for the treatment
of erectile dysfunction ("ED") as a De Novo Medical Device.

 

MED3000 can now be legally marketed in the USA as the first topical treatment
for ED available OTC without the need for a prescription. MED3000 is approved
as an effective, clinically proven treatment for ED with a 10-minute onset of
action. Oral medications ("PDE5i's") such as Cialis and Viagra require a
doctor's prescription in the USA and typically are required to be taken at
least 30 minutes in advance.

 

The prevalence of ED disrupts the lives of at least 1 in 5 men globally(1)
with around 22 million men suffering ED in the US making the US the largest ED
market in the world.

 

MED3000 has already been approved as the first pan-European clinically proven
topical treatment for ED available OTC and is now available in Belgium and the
UK.  Initial launches commenced under the brand name Eroxon® in March 2023
with further launches planned through 2023 and beyond with commercial
agreements in key markets including the European Economic Area, UK,
Switzerland, South Korea, Latin America and Middle East.

 

James Barder, Chief Executive Officer of Futura Medical said: "The granting of
marketing authorisation by the US FDA as the first clinically proven, topical
gel for the treatment of ED in the USA available without a doctor's
prescription is a huge milestone for Futura and highlights the incredible
progress that the Company continues to make.  FDA set a very high standard in
evaluating the effectiveness and safety of De Novo Medical Devices.  I am
delighted that we met this standard with MED3000's submission of 22 clinical,
biocompatibility, human factors studies and performance bench tests which were
rigorously reviewed and accepted by the FDA.  The FDA approval is a major
de-risking event for the Company and we look forward to updating shareholders
on our US commercialisation plans in due course."

1.      EMA, Withdrawal assessment report for Viagra, 2008

The information communicated in this announcement contains inside information
for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014
as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.

ENDS

For further information please contact:

 

Futura Medical plc

James Barder, Chief Executive Officer

Angela Hildreth, Finance Director and COO

Email: investor.relations@futuramedical.com
(mailto:Investor.relations@futuramedical.com)

Tel: +44 (0) 1483 685 670

www.futuramedical.com (http://www.futuramedical.com/)

 

Nominated Adviser and Sole Broker:

 

Liberum

Phil Walker/ Richard Lindley/ Ben Cryer

Tel: +44 (0) 20 3100 2000

 

For media enquiries please contact:

Optimum Strategic Communications

Hollie Vile/ Jonathan Edwards/ Zoe Bolt

Email: futuramedical@optimumcomms.com

Tel: +44 (0) 203 882 9621

 

About Futura Medical plc

Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a
portfolio of innovative products based on its proprietary, transdermal
DermaSys® technology. Each DermaSys® formulation is separately patented and
specifically tailored for the selected indication and application, as well as
being optimised for clinical efficacy, safety, administration and patient
convenience. The products are developed for the prescription and consumer
healthcare markets as appropriate. Development and commercialisation
strategies are designed to maximise product differentiation and value creation
whilst minimising risk.

MED3000 is Futura's topical gel formulation that is a novel treatment for
erectile dysfunction (ED) through a unique evaporative mode of action. Futura
has conducted two Phase 3 studies using MED3000 in ED; FM57 study which
enabled Futura to be granted a CE Mark in 2021 and FM71 which enabled Futura
to be granted US marketing authorisation. Both studies demonstrated that
MED3000 presents an effective clinically proven treatment for ED with a rapid
speed of onset and a favourable benefit versus risk profile ideally suited for
an 'Over the Counter' classification.

Eroxon® is FDA approved in the US, CE marked in Europe and UKCA marked in
the UK as a clinically proven topical treatment for adult men with
erectile dysfunction under the brand Eroxon® with a key claim of "Helps you
get an erection within 10 minutes". Eroxon® is the agreed brand name in
certain regions such as the EU whereas MED3000 continues to be the internal
code name used by the Company and also in reference to countries where
regulatory approval or commercial distribution agreements have not yet been
achieved. www.eroxon.com (http://www.eroxon.com)

Futura is based in Guildford, Surrey, and its shares trade on the AIM market
of the London Stock Exchange. www.futuramedical.com
(http://www.futuramedical.com/)

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