Last checked at 15 Feb 2023 07:00
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 (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.
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 Ralph1, Tim Holland2, Ken James2
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
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
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/