Futura Medical Regulatory News (FUM)

14 July 2020

Futura submits MED3000 under the EU Medical Device Regulation and provides update on US regulatory proceedings

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 announce that it has now submitted the product dossier for its treatment of erectile dysfunction ("ED") known as MED3000 under the European Medical Device Regulation for marketing approval.

In February 2020, Futura commenced formal proceedings for MED3000 to be approved as a medical device and a clinically proven treatment for Erectile Dysfunction (ED) in Europe by an EU Notified Body1. These proceedings have now allowed the Company to submit the MED3000 product dossier for review, including the Clinical Study Report (CSR) for FM57 and technical specifications of the Company's Quality Management System. The Company expects to be able to provide a further update on the progress of MED3000 EU regulatory approval at the time of its interim results in September but continues to target a 2021 approval date.

The Company has also now had a second pre-submission meeting with the US Food and Drug Administration (FDA), as a result of which the Board believes a pathway to a marketing approval for MED3000 in the USA has been established, and importantly, without the need for a doctor's prescription. None of the market leading treatments for ED, such as Viagra and Cialis, are currently approved in the USA without the need of a doctor's prescription and the Company has seen a high level of interest from potential commercial partners for a clinical proven treatment for ED which is available without the need of a doctor's prescription, known as Over the Counter ("OTC").

The FDA have indicated a requirement for certain additional clinical efficacy data beyond the Company's three months' home use study conducted in 2019 in 1,000 patients suffering from mild, moderate and severe ED ("FM57"). This additional data will require a further small clinical trial where patients with ED will receive MED3000 for a six month treatment period. The FDA has expressed a willingness to work with the Company to develop the least burdensome design. Confirmatory studies such as this generally require low subject numbers and is likely to be significantly smaller in size than FM57. Official minutes from this second pre-submission meeting with the FDA are expected to be available by the end of September.

Next steps will be to confirm design of the new clinical trial with FDA to provide the necessary reassurance of MED3000's efficacy for up to six months and progress the OTC label and leaflet development. The requirement of FDA for Futura to run a small confirmatory study of 6 months duration in addition to the completed large pivotal study, FM57 is significantly less burdensome in the Board's view than two large pivotal studies of 12 and 3 months duration that would have been required as a drug product as opposed to a medical device. Futura expects to be in a position to give a progress update in the coming months.

James Barder, Chief Executive of Futura Medical commented: "Futura is executing and delivering against strategic plans. We are pleased to have now submitted MED3000 for European approval as a clinically proven treatment for ED. Once granted, EU approval will allow MED3000 to be marketed throughout the EU without the need of a doctor's prescription subject to any national marketing restrictions. This represents a significant commercial opportunity."

He added, "Commercial partnering interest in MED3000, where received, has strongly focused on its potential in OTC markets as well as for prescription use. We expect a large OTC market opportunity for MED3000 in ED especially within the biggest ED market, the USA, where its differentiation on speed of onset, high tolerability and safety combined with efficacy will provide a new, accessible option for many patients suffering from the debilitating effects of the condition."

Note

¹Notified Bodies are organizations designated by EU countries to oversee the approval of medical devices within the EU and the UK.

-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