RCS - Futura Medical PLC - Eroxon® Granted Marketing Authorisation in Mexico

Futura MedicalAnnouncement

25/10/2023 07:15

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RNS Number : 1492R  Futura Medical PLC  25 October 2023

 

 25 October 2023

 Futura Medical plc

("Futura" or the "Company")

Eroxon® Granted Marketing Authorisation in Mexico

Futura Medical plc (AIM: FUM), the pharmaceutical company developing
innovative sexual health products, today announces that the Mexican
Secretariat of Health has granted over the counter sale ("OTC") Marketing
Authorisation for Eroxon®, the Company's breakthrough, topical gel
formulation for the treatment of erectile dysfunction ("ED").

 

Eroxon® can now be marketed in Mexico as a topical treatment for ED available
OTC without the need for a prescription. Eroxon® is approved as an effective,
clinically proven treatment for ED with a 10-minute onset of action.

 

The prevalence of ED disrupts the lives of at least 1 in 5 men globally(1).
Mexico currently has a population of 129 million².

 

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

 

James Barder, Chief Executive Officer of Futura said: "Following the approval
by the US FDA earlier this year, Mexican marketing authorisation opens up
another very large and exciting market for Eroxon®. Mexico is a vibrant and
dynamic market, and we look forward to bringing the benefits of Eroxon® to ED
sufferers in Mexico with our commercial partner M8."

EMA, Withdrawal assessment report for Viagra, 2008

1.      EMA, Withdrawal assessment report for Viagra, 2008

2.      https://www.unfpa.org/data/world-population/MX
(https://www.unfpa.org/data/world-population/MX)

 

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/)

 

For media enquiries please contact:

Optimum Strategic Communications

Nick Bastin / Jonathan Edwards / Zoe Bolt / Elena Bates

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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