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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(R) 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(R)
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(R) has been received to enable initial launches
through its European & UK distribution partner, Cooper Consumer
Health and the planned debut of Eroxon(R) remains on track. In
addition, we are also pleased to announce that the first production
order for initial launches of Eroxon(R) 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 :
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(R), 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(R) 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
Tel: +44 (0) 1483 685 670
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(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
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END
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