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RNS Number : 8454C
Futura Medical PLC
22 October 2020
22 October 2020
Futura provides regulatory and commercial update for MED3000
Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), 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 update progress on regulatory processes and
commercial activities for MED3000. MED3000 is the company's
breakthrough, topical gel formulation for treatment of erectile
dysfunction (ED) and Futura is seeking marketing approval for the
product in Europe and the USA for use as a clinical treatment of ED
without the need of a doctor's prescription, with plans to file in
other regions in due course.
US regulatory process
Further to the Company's update on 16 September, Futura has
continued to work proactively with the FDA to confirm the design of
the requested supplemental clinical trial to provide the necessary
reassurance of MED3000's efficacy for up to six months. The
Company's previous 1,000 patient study (FM57), which reported
results in December 2019, met all its primary endpoints against a
pre-treatment baseline and across all ED severities for efficacy
for up to three months and also provided extensive safety
reassurance. In addition, progress has been made around the label
and leaflet development to enable the product to be approved by the
FDA without the need of a doctor's prescription.
The Company is pleased to confirm that following its third
pre-submission meeting with FDA, there was preliminary agreement on
the design and scope of this small supplementary study, known as
"FM71" subject to the issue of the final meeting minutes. The final
study protocol can only be completed once the FDA minutes have been
received. However, based on the pre-submission discussions FM71 is
expected to be a comparative, randomised, open label, home use,
parallel group study in approximately 100 patients with erectile
dysfunction. Approximately 20 subjects will be located in the
United States to provide reassurance that data generated outside
the US is comparable to the US population. As an open-label design
the study will be neither placebo controlled nor double-blinded,
the study's primary endpoint will be to compare MED3000 against a
pre-treatment baseline for efficacy for up to six months. The
lowest "on demand" dose of tadalafil, 5mg (Cialis) will also be
measured against pre-treatment baseline to enable the FDA to
compare an overall risk/benefit analysis of the two treatments for
the 6 month period of the study looking at efficacy, speed of onset
and safety. 50 patients with ED will be included in each treatment
arm of the study.
Detailed planning for the study has now commenced and Futura is
targeting Q1 2021 patient enrolment depending on completion of the
final study protocol for FM71.
European regulatory process
Futura announced in mid-July that it had submitted the product
dossier for MED3000 for treatment of ED under the European Medical
Device Regulation for marketing approval as a Class 2B medical
device.
The EU approval process continues to progress well. Completeness
checks under the new European Medical Device Regulation have been
successfully concluded, the MED3000 dossier is under review by the
regulator and Futura continues to target a 2021 European approval
for MED3000.
Commercialisation
In parallel with the regulatory processes Futura has been
working with retained specialised corporate advisers on active
commercial discussions with potential licensing and marketing
partners.
Discussions continue with a growing number of parties in line
with an agreed process being managed by Futura's corporate
advisers. Nevertheless, priority has been given to certain
negotiations for one specific region where discussions have
advanced with parties for the exclusive marketing rights for
MED3000. The Company has reasonable expectations that these
negotiations will be satisfactorily concluded with one of several
interested parties although no guarantees can be given at this
stage that any of these negotiations will conclude
successfully.
James Barder, Chief Executive of Futura Medical commented: "We
are happy to see continuing, positive regulatory progress for
MED3000 in parallel with advancing commercial discussions and the
board is hopeful of signing at least one agreement with a third
party. We are increasingly excited at the prospects of bringing to
market the first over the counter, topically applied clinically
proven treatment for erectile dysfunction with a faster onset of
action and enhanced safety profile compared to currently available
oral, on demand, drug treatments."
-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
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Supriya Mathur
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 922 0891
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 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.
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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