Futura Medical PLC Eroxon(R) Granted Marketing Authorisation in Mexico

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Futura Medical PLC

25 October 2023

25 October 2023

Futura Medical plc

("Futura" or the "Company")

Eroxon (R) 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 (R) , the Company's breakthrough, topical gel formulation for the treatment of erectile dysfunction ("ED").

Eroxon(R) can now be marketed in Mexico as a topical treatment for ED available OTC without the need for a prescription. Eroxon(R) 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 million (2) .

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. I nitial launches commenced under the brand name Eroxon(R) in March 2023, w ith 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(R) . Mexico is a vibrant and dynamic market, and we look forward to bringing the benefits of Eroxon(R) 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 

ENDS

For further information please contact:

Futura Medical plc

James Barder, Chief Executive Officer

Angela Hildreth, Finance Director and COO

Email: [e-mail]

Tel: [phone]

www.futuramedical.com

For media enquiries please contact:

Optimum Strategic Communications

Nick Bastin / Jonathan Edwards / Zoe Bolt / Elena Bates

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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(R) technology. Each DermaSys(R) 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(R) 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(R) with a key claim of "Helps you get an erection within 10 minutes". Eroxon(R) 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

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

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October 25, 2023 02:00 ET (06:00 GMT)