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® 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.
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."
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Tel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:
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
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