Futura Medical Regulatory News (FUM)

19 July 2021

Futura Medical plc

Futura provides FDA 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 provide an update on FDA regulatory processes and commercial activities for MED3000. 

US regulatory progress

Last week Futura met with the FDA for a pre-submission meeting to define and confirm the detail of the work required for OTC classification in the USA for MED3000, the Company's breakthrough fast acting clinically proven treatment for erectile dysfunction ("ED").

The Company is pleased to confirm that the FDA has agreed to the design of the non-clinical, Human Factors Study, subject to the issue of the final meeting minutes. The study will test the ability of subjects to self-diagnose their ED, correctly select the product based on label information and test their ability to correctly use the product without supervision of a doctor. The FDA has asked for a minimum of 15 subjects to complete the study.

As previously communicated, comprehensive planning and preparation activities including active site selection are well underway for the commencement of FM71, the required confirmatory clinical study, with the first patient dosing expected during Q3 2021 targeting completion of the FM71 study and Human Factors study for Q2 2022. US OTC marketing authorisation remains on track for approval for MED3000 in Q1 2023.

Commercial progress

Manufacturing scale up and capacity to meet projected demand is progressing well in conjunction with commercial out-licensing agreements covering the remaining major regions and countries of the world with a number of interested parties. As previously outlined, Futura expects to be able to update shareholders further during the remainder of 2021 as it looks to target the launch of MED3000 during 2022.

MED3000, is a topical gel which utilises our proprietary technology DermaSys®, developed specifically for the treatment of erectile dysfunction ("ED"). It is a fast-acting topical treatment which has the potential to be a highly differentiated product by addressing significant unmet needs in the ED market.

James Barder, Chief Executive of Futura Medical commented: "Subject to receipt of the final meeting minutes we are pleased that the requirements to enable an OTC application for MED3000 have been clarified with the FDA. In addition, we remain focused on preparation and execution of the FM71 study with the first patient dosing expected later this year. The USA remains the largest market opportunity globally for ED treatments and we are making steady progress on attaining approval for MED3000 in the region."

-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

Richard Lindley/ Euan Brown/ Kane Collings

Tel: +44 (0) 20 3100 2000

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile

Email: futuramedical@optimumcomms.com

Tel: +44 (0) 20 3922 0900

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. MED3000 is CE marked in Europe and the UK as a clinically proven topical treatment for adult men with erectile dysfunction.

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