REG - Futura Medical PLC - Application to the US FDA for MED3000

Futura MedicalAnnouncement

03/10/2022 07:01

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20221003:nRSC4321Ba&default-theme=true

RNS Number : 4321B  Futura Medical PLC  03 October 2022

 

3 October 2022

 Futura Medical plc

("Futura" or the "Company")

 

Futura Announces Completion of its De Novo Medical Device Application to the
US FDA for its Breakthrough Topical Gel Formulation MED3000 for Erectile
Dysfunction

 

Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio
of innovative products based on its proprietary, transdermal DermaSys® drug
delivery technology and currently focused on sexual health and pain, today
announced that it has now completed all of the work that it believes is
required for the FDA to grant marketing authorisation for MED3000, its fast
acting clinically proven treatment for erectile dysfunction (ED).  The
dossier will now be submitted to the FDA and the Company remains confident of
being granted marketing authorisation by the FDA by the end of Q1 2023 in line
with previously announced timelines. This follows the April 2021 approval of
MED3000 CE Mark as the first clinically proven, pan-European (including UK)
topical treatment for adult men with ED that will be available without a
doctor's prescription.

 

The FDA submission closely follows FDA guidance on De Novo applications, and
guidance received from FDA CDRH in five pre-submission meetings held with the
Company.  This includes a Human Factors study supporting Over-The-Counter
(OTC) designation and two phase 3 clinical studies with MED3000 for the
treatment of mild, moderate and severe ED; FM57 clinical trial used for
approval in Europe, and the recently announced results from the FDA agreed
pivotal Phase 3 clinical study, FM71 which successfully met all primary and
secondary endpoints. The results demonstrate 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 OTC classification
in the US.

 

Subject to FDA granting Marketing Authorisation, MED3000 will become the first
major ED treatment available OTC throughout the USA.

 

Futura continues to strengthen its wide network of licensing and distribution
partners across the globe and has recently announced the search for US
commercial partners has commenced following the successful completion of FM71
and the completion of the FDA submission which represent a major value
inflection point.

 

James Barder, Chief Executive Officer, Futura Medical said: "Today marks a
pivotal milestone for Futura and highlights the regulatory progress we have
made to develop and launch MED3000 globally. The submission of our marketing
application in the US will pave the way for commercialisation of MED3000 in
the biggest ED market worldwide with our key differentiator of a clinically
proven treatment for ED with a rapid speed of onset. MED3000 is also expected
to be the first major ED treatment available OTC in the USA which we believe
will help improve access as well as treatment for many thousands of ED
sufferers. We believe Eroxon, the brand for MED3000, is poised to become a
major, trusted brand and treatment in the ED market worldwide."

 

For further information please contact:

 

Futura Medical plc

James Barder, Chief Executive

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/)

Nominated Adviser and Sole Broker:

 

Liberum

Phil Walker/ Richard Lindley/ Ben Cryer/ Kane Collings

Tel: +44 (0) 20 3100 2000

 

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)

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCQBLFXLKLLBBD