REG - Futura Medical PLC - US regulatory and commercial update for MED3000

Futura MedicalAnnouncement

20/12/2021 07:01

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RNS Number : 0696W  Futura Medical PLC  20 December 2021

20 December 2021

 Futura Medical plc

("Futura" or the "Company")

Futura provides US regulatory and commercial update for MED3000

 

Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio
of innovative products for sexual health and pain relief, is pleased to
provide an update on good progress with its regulatory and commercial
activities for MED3000.

 

MED3000 is the Company's breakthrough, topical gel formulation for treatment
of erectile dysfunction ("ED").  It has the potential to become the first
globally available, clinically proven, over the counter ("OTC") treatment for
erectile dysfunction and has already been approved as the first pan-European
topical treatment for ED available without the need of a doctor's
prescription. The USA market is the largest ED market globally and the
company's objective of OTC status for MED3000 continues to be a top priority
given its potential to be the first OTC clinically proven treatment for ED.

 

US regulatory process

As previously announced, the FDA has agreed that an application may be made
for MED3000 as a medical device for ED treatment, with a De Novo
classification. Multiple productive and positive pre-submission meetings were
held with the FDA during 2020 and 2021 to discuss existing Phase 3 clinical
data, pathway to OTC status and any additional clinical and non-clinical
requirements.

 

The FDA required an additional 6-month confirmatory clinical study, known as
"FM71", with MED3000 taking a "least burdensome approach", as well as a short,
non-clinical, "Human Factors" study to test the ability of subjects to
self-diagnose their ED, correctly select the product based on label
information and test subject's ability to correctly use the product without
supervision of a doctor. The FDA asked for a minimum of 15 subjects to
complete the study.

 

The "Human Factors" study has been successfully completed with 32 subjects
entering the study.  It was demonstrated that individuals are able to
correctly self-diagnose ED and to make correct self-selection decisions by
considering their own health history and the instructions for use and warnings
on the label. Overall, there was a very high degree of comprehension of the
label and leaflet to increase confidence that the product will be used
appropriately in an OTC setting. These results therefore support the
regulatory submission for OTC designation and enable Futura to finalise the
OTC product label for a US filing.

 

US confirmatory clinical study, FM71

FM71 is a confirmatory clinical study with MED3000 designed to provide
supplementary 6-month efficacy data with a "least burdensome" approach and
modest cost. In September 2021 Futura announced that the first patient had
entered pre-screening in FM71.

 

Just over 100 patients have now been successfully enrolled into the study,
including a mix of mild, moderate and severe ED sufferers with patients
recruited from Eastern Europe and African American patients from a leading US
medical centre. The Company aims to continue to recruit up to a further ten
patients (to allow for any patient drop-outs, a normal feature in any clinical
study) before closing recruitment in the next few weeks. Timelines remain on
track to enable planned US regulatory submission by the end of Q3 2022, and
for targeting US OTC FDA approval of MED3000 in Q1 2023.

 

MED3000 commercialisation and manufacturing

2021 saw the Company enter into several commercial licensing deals in large
markets for ED in regions such as China and South East Asia, Latin America and
the Middle East.

 

Futura is in advanced discussions for other commercial out-licensing
agreements covering additional major regions and countries of the world with
multiple interested parties. The Company looks forward to providing further
updates in 2022.

 

Scale-up of manufacturing and production capacity to meet projected demand
continues to progress well as Futura works towards an initial launch of
MED3000 in certain countries in 2022.

 

James Barder, Chief Executive of Futura Medical commented: "We are continuing
to make good progress with the regulatory process for MED3000 in the US.  We
are also executing upon our strategic plans to leverage commercialisation
globally with a network of licensing and distribution partners with brand
building strength, healthcare credibility and regional infrastructure and
marketing expertise. 2021 has been a year of transformational progress for
Futura and we are excited to be bringing more patients across the globe an
accessible, new treatment option for their ED. We look forward to further
updates for shareholders during what we believe will be an exciting 2022 for
Futura.  In the meantime we wish all our shareholders and staff a happy
festive season."

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

 

Nominated Adviser and Sole Broker:

Liberum

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 (mailto:ziylo@optimumcomms.com)

Tel: +44 (0) 20 3922 0891

 

Notes to editors:

 

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 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,
consistently meeting all co-primary endpoints of IIEF, SEP2 and SEP3
(internationally accepted clinical trial endpoints in ED) with over 60% of
patients experiencing a clinically meaningful improvement in their ED.
MED3000 also begins to work immediately in some patients, with 60% of patients
seeing onset of their erection within 10 minutes of application. MED3000 is
CE marked in Europe and the UK as a clinically proven topical
treatment for adult men with erectile dysfunction.

 

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/)

 

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