TIDMFUM
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(R) 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 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
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(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. 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(TM) 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/
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END
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February 15, 2023 02:00 ET (07:00 GMT)
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