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RNS Number : 8341H
Futura Medical PLC
08 December 2020
08 December 2020
Futura provides US regulatory and commercial update
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 provide an update on regulatory processes and
commercial activities for MED3000. MED3000 is the Company's
breakthrough, topical gel formulation for treatment of erectile
dysfunction (ED). Futura is seeking marketing approval for the
product in Europe and the USA for use as an over-the-counter (OTC)
clinical treatment of ED thereby removing the need for a doctor's
prescription, with plans to file in other regions in due
course.
US regulatory process
The Company has recently received the pre-submission minutes of
the FDA meeting held on 19 October 2020. The minutes confirm the
outline design of the requested supplemental clinical trial, known
as "FM71" the parameters of which were broadly described in the
update on 22 October 2020. Assuming it meets its primary endpoints,
FM71 would provide the FDA with the necessary reassurance of
MED3000's efficacy and safety for up to six months use by ED
patients. FDA continue to provide constructive comment on the
development of a product label to achieve OTC status for MED3000
which is reflected in the official minutes.
Futura has submitted a final detailed clinical study protocol to
the FDA and a meeting with the FDA has been scheduled for February
2021 to agree details primarily related to the statistical analysis
plan.
Meanwhile, detailed planning and preparatory activities for the
study are continuing and Futura expects patient enrolment to
commence as soon as feasible after final advice on the final FM71
study protocol is received from FDA.
European regulatory process
Futura announced in mid-July that it had submitted the technical
file 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, with the
MED3000 technical file now actively under review by the regulator.
Futura continues to target a 2021 European approval for
MED3000.
Commercialisation
As regulatory processes continue Futura has been working with
retained specialised corporate advisers on active commercial
discussions with potential licensing and marketing partners in line
with an agreed process being managed by the advisers.
Futura announced in late-October that it had given priority to
certain negotiations for one specific region for the exclusive
marketing rights for MED3000, with certain parties. These
discussions have progressed positively and the Company has signed
non-binding terms and entered into exclusive negotiations for a
specific region. The Company continues to have reasonable
expectations that agreement can be reached with this party,
although no guarantees can be given that these negotiations will
conclude successfully.
James Barder, Chief Executive of Futura Medical commented: "We
are continuing to progress along the regulatory timeline for
MED3000 and executing upon our strategic plans. Aside from the
prioritised regional negotiations, Futura is making steady progress
on commercial discussions in multiple other regions. We look
forward to providing further updates as we move ahead on both
regulatory and commercial tracks."
-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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