Futura Medical Regulatory News (FUM)

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® 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® 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.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com