RCS - Futura Medical PLC - MED3000 FM71 Presentation at ESSM Congress 2023

Futura MedicalAnnouncement

15/02/2023 07:16

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RNS Number : 9209P  Futura Medical PLC  15 February 2023

 15 February 2023

Futura Medical plc

("Futura" or the "Company")

Futura Medical to present MED3000 FM71 data at the European Society for Sexual
Medicine Congress 2023

 

Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio
of innovative products based on its proprietary, transdermal DermaSys® drug
delivery technology, with a current focus on sexual health and pain, today
announces that it will be presenting data on its lead product MED3000 for the
treatment of erectile dysfunction ("ED") at the European Society for Sexual
Medicine (https://www.essm-congress.org/) (ESSM) Congress in Rotterdam, The
Netherlands on the 16-18 February 2023.

 

MED3000 is a breakthrough, fast acting topical gel formulation with a unique
evaporative mode of action, which is applied to the glans penis by the male or
his partner for the treatment of ED. MED3000, is CE marked in Europe and CA
marked in the UK, as a clinically proven topical treatment for adult men
with ED that helps men get an erection within 10 minutes.

Ken James, Executive Director and Head of R&D at Futura Medical said: "We
are pleased to present the previously reported, highly positive MED3000 data
at ESSM. Erectile dysfunction has a significant impact on the quality of life,
relationships and overall wellbeing of sufferers and their partners. MED3000
has the required efficacy, speed of onset and favourable safety profile
consistent with an over-the-counter, use therapy. It will help address the
needs of many men who for whatever reason are not treating their condition or
are dissatisfied with their current treatment. We are excited at the prospect
of bringing a truly unique and differentiated treatment option to the market."

 

The Poster will be presenting the recent, positive FM71 Phase 3 Study Results
(https://polaris.brighterir.com/public/futura_medical/news/rns/story/r79j3zx)
.

Details of the presentation are as follows:

 

Poster Presentation

Abstract: MED3000, a clinically proven, fast-acting topical product for
Erectile Dysfunction with the prospect of being the first globally available
OTC treatment for ED

Authors: David Ralph(1), Tim Holland(2), Ken James(2)

Date & Time: 16 February, 10.00 CET

Booth: 1

 

(1) University College London

(2) Futura Medical Developments Limited (FMD)

 

MED3000 is the first pan-European topical treatment for ED available without
the need of a doctor's prescription and available over the counter ("OTC").

 

Cooper Consumer Healthcare, a leading International independent self-care
organisation that now holds the rights to commercialise MED3000 throughout the
EEA, the United Kingdom and Switzerland will be in attendance.

 

Cooper is on track to launch MED3000 in the first half of 2023, as previously
guided, and has already commenced pre-launch activities and expects the first
product supplies to be available in the coming months.

 

Subject to the US Food and Drug Administration ("FDA") granting Marketing
Authorisation, MED3000 has the potential to become the first major ED
treatment available OTC throughout the USA.

 

Futura has established a network of licensing and distribution partners with
strength in brand building, pharmaceutical credibility, regional
infrastructure, and marketing expertise for long-term distribution of MED3000
across the globe.

 

To date, Futura has signed commercial agreements in key markets including the
European Economic Area (EEA), the United Kingdom, the Gulf Co-operation
Council (GCC) region, Switzerland and South Korea. It has also established a
strong and expanding distribution platform for regions outside the key US
market. As announced in December 2022, Futura's corporate advisors formally
commenced the search for a US commercial partner and continue to be engaged in
a number of ongoing discussions.

 

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

Tel: +44 (0) 1483 685 670

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

 

For media enquiries please contact:

 

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile/ 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. Current therapeutic areas are sexual
health, including erectile dysfunction, and pain relief. 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 breakthrough treatment
for erectile dysfunction ("ED") through a unique evaporative mode of action.
Futura has previously conducted a Phase 3 study using MED3000 in ED, referred
to as "FM57". This was a 1,000 patient, dose-ranging, multi-centre,
randomised, double blind, placebo-controlled, home use, parallel group study
delivering highly statistically significant results compared to pre-treatment
baseline, using measures IIEF-EF, SEP2 and SEP3 (internationally accepted
clinical trial endpoints in ED) with over 60% of patients experiencing a
clinically meaningful improvement in their ED.

 

MED3000 is CE marked in Europe and CA 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".

 

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)

 

About Cooper Consumer Health Group (CCH)

Cooper Consumer Health Group (CCH) is the largest independent selfcare
organization in Europe that is active in the OTC consumer healthcare market
with the development, manufacturing, selling and marketing of selfcare
products (e.g., medicines, medical devices, cosmetics, biocides and food
supplements) under its own or licensed brands.

The ambition of our group is to offer selfcare solutions to everyone based on
a European brands portfolio. CCH has proven its capacity to integrate new
activities and aggregate talents by capitalising on the strengths and the
structure of its group. https://www.cooperconsumerhealth.eu/
(https://www.cooperconsumerhealth.eu/)

 

 

 

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