Futura Medical Regulatory News (FUM)

20 April 2020

Futura files for Further Pre-Submission meeting with the FDA following receipt of its Phase 3 clinical study report

Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology and currently focused on sexual health and pain, is pleased to announce that it has now filed for a further pre-submission meeting with the US FDA following receipt of the complete and signed clinical study report (CSR) for its Phase 3 Study (FM57). This follows initial presentation of existing clinical evidence from the FM57 study at an FDA pre-submission meeting on 24th February 2020.

FM57 reported top line results in December 2019. It was a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study for the Company's lead product, MED3000, a topical treatment for Erectile Dysfunction (ED). It demonstrated that MED3000 has the potential to be a highly effective, clinically proven, topical treatment for ED, with a fast onset of action and excellent safety profile.

As disclosed on 6 April 2020, the US FDA has agreed to a De Novo medical device application for MED3000 subject to Futura pursuing another pre-submission meeting to further discuss clinical sufficiency and/or post-marketing requirements, with reference to the full FM57 CSR and other supporting information. Futura has now filed for the pre-submission meeting and expects this second meeting to take place in the coming months. If the outcome of the meeting is positive, this could lead to a US submission filing in Q3 2020 for FDA review for pre-marketing clearance.

James Barder, Chief Executive of Futura Medical, commented: "Following extensive review of the clinical data, we are pleased to have received the completed and signed CSR for FM57, and have filed the necessary data in order for the company to have the next pre-submission meeting to further discuss clinical sufficiency and/or post-marketing requirements for MED3000. As a breakthrough treatment for erectile dysfunction (ED), we are confident that we will receive MED3000 approval as a medical device, and we continue to target the next six months for regulatory submissions in both Europe and USA."

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/ Hollie Vile

Email: futuramedical@optimumcomms.com

Tel: +44 (0) 203 950 9144

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