REG - Futura Medical PLC - Futura Medical announce milestone year for MED3000

Futura MedicalAnnouncement

13/12/2022 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:20221213:nRSM4326Ja&default-theme=true

RNS Number : 4326J  Futura Medical PLC  13 December 2022

 

13 December 2022

 Futura Medical plc

("Futura" or the "Company")

 

Update on a milestone year of regulatory and commercial progress for MED3000

 

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, is
pleased to provide an update on a pivotal year of regulatory progress and
commercial activities for MED3000.

 

MED3000 is the Company's breakthrough, topical gel formulation for the
treatment of erectile dysfunction ("ED") and is approved as the first
pan-European topical treatment for ED available without the need of a doctor's
prescription and available over the counter ("OTC"). Subject to 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.

 

Middle East Regulatory progress

We are pleased to announce that the first marketing authorisation for MED3000
has now been granted in three Middle Eastern countries including the UAE.
 Further additional approvals are expected as we move into 2023 alongside
initial launches, where regulatory approval has been received, under the
Eroxon® brand.

 

US Regulatory progress

In 2021, the FDA requested an additional Phase 3 clinical study, known as
"FM71" for MED3000, designed to provide 24-week efficacy and safety data. The
study protocol was agreed with the FDA prior to commencing the study in
September 2021. Results, announced in August 2022, demonstrated that all
primary and secondary endpoints had been met with a highly favourable safety
and tolerability profile with no serious adverse events recorded.

 

Based on these results, Futura filed an application for Marketing
Authorization as a De Novo Medical Device in October 2022, presenting the case
that MED3000 is an effective clinically proven treatment for ED with a
10-minute onset of action and a favourable benefit versus risk profile ideally
suited for OTC classification.

 

The FDA has now confirmed that the dossier is under formal review and has
indicated that the dossier has successfully passed the initial technical
screening. Based on the FDA's published target review period guidelines,
granting of marketing authorisation remains on track to be achieved by the end
of Q1 2023, in line with previously announced timelines.

 

EU Regulatory progress

In April 2022, Futura obtained the UKCA mark for MED3000 as a Class 2A medical
device, required due to post Brexit arrangements, supplementing the EU CE mark
obtained in 2021.

MED3000 commercialisation and launch plans

In the past 18 months, Futura entered into and signed multiple commercial
agreements throughout the European Economic Area, the United Kingdom, the Gulf
Co-operation Council (GCC) region, Switzerland and South Korea. The Company is
continuing to expand its strong network of licensing and distribution partners
as it moves towards initial launches of MED3000 in the first half of 2023.

 

In line with the Board's US commercialisation strategy following the
successful completion of FM71 and the FDA dossier submission in October 2022,
Futura's corporate advisors have formally commenced the search for a US
commercial partner and are engaged in a number of ongoing discussions. The
Company looks forward to providing a further update in due course.

 

As previously reported in September 2022, the first production order of
Eroxon® has been received to enable initial launches through its European
& UK distribution partner, Cooper Consumer Health and the planned debut of
Eroxon® remains on track. In addition, we are also pleased to announce that
the first production order for initial launches of Eroxon® in the Middle
East, which are planned for 2023, has been agreed through our distribution
partner Labatec Pharma.

 

MED3000 education

In October 2022, Futura attended the joint meeting of the Sexual Medicine
Society of North America (SMSNA) and the International Society of Sexual
Medicine (ISSM) in Miami. An Advisory Panel meeting comprised of eight world
renowned experts in Sexual Medicine from the USA, Europe, UK and Brazil was
convened to discuss MED3000's clinical data, its unique mode of action and how
it could be used as a treatment alternative for ED. MED3000 was acknowledged
by the Advisory Panel as a potential, safe, fast-acting and effective
treatment for addressing the medical unmet need of ED via OTC. Two members of
the Panel, Professor Hellstrom and Dr Glina recorded their specific thoughts
on how MED3000 might be of benefit to patients. The video can be accessed on
the Futura Medical website here
(https://www.futuramedical.com/investor-centre/videos-and-webcasts/videos/) :

 

James Barder, Chief Executive Officer, Futura Medical said: "We are delighted
with the significant progress we have achieved during 2022 and are looking
forward to 2023 which we believe will be a very exciting and pivotal year for
the Company with initial launches of Eroxon®, the brand name for MED3000. We
remain on track to be granted US marketing authorisation for MED3000 by the
end of Q1 2023 as a clinically proven, fast-acting, topical treatment with a
highly favourable side effect profile for ED patients, without the need for a
doctor's prescription. As we move towards initial launches and strategic scale
up of commercialisation of Eroxon® in the first half of 2023, we hope to be
able to transform the lives of ED patients around the world with our
breakthrough OTC product.

 

"I would like to thank all our shareholders for supporting the Company, as
well as our employees and commercial partners for their commitment and hard
work throughout 2022 and we look forward to updating the market on future
achievements in 2023."

 

ENDS

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  RESGPGAGPUPPGQP