Futura Confirms Receipt of US FDA Minutes

RNS Number : 8130I

Futura Medical PLC

06 April 2020

 

6 April 2020

Futura Confirms Receipt of US FDA Minutes

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 received official minutes from the US Food and Drug Administration (FDA) following its pre-submission meeting on 24 February 2020.

The Company presented existing clinical evidence from its Phase 3 Study (FM57) and the case for filing for FDA clearance for its lead product, MED3000, a topical treatment for Erectile Dysfunction (ED), as a medical device with a De Novo Classification. This follows top line results from the FM57 study announced in December 2019, that 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.

The minutes confirm the Company's expectations as disclosed in the Full Year Results 2019, announced on 1 April 2020, that the US FDA has agreed to a De Novo medical device application subject to Futura pursuing another pre-submission meeting to further discuss clinical sufficiency and/or post-marketing requirements once the clinical study report ("CSR") for FM57 is available.  Management expects this second meeting to take place in the coming months. If successful, 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: "We are very pleased to have received official confirmation of what will be required to progress MED3000 towards a potential approval as a medical device as a clinically proven ED therapy. Futura remains in consultation with the FDA regarding overall data requirements as we move towards targeted regulatory submissions for MED3000 in both the US and EU in the next six months .

"The Company also announced in February 2020, following positive interactions with an EU Notified Body¹, that it had commenced formal proceedings for MED3000 in Europe. These proceedings will allow the Company to submit its technical file for review by the said Notified Body, including the CSR for FM57 and the Company's Quality Management System by the end of July 2020. In Europe medical device applications are typically for Over the Counter status by default."

Note

1. Notified Bodies are the regulatory authorities that oversee the approval of medical devices within the EU for all EU countries including the UK.

For further information please contact:

Futura Medical plc

James Barder, Chief Executive

Angela Hildreth, Finance Director and COO

Email: [e-mail]  

Tel: [phone]

www.Futuramedical.com

Nominated Adviser and Sole Broker:

Liberum

Bidhi Bhoma/ Euan Brown/ Kane Collings

Tel: [phone]

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile

Email: [e-mail]

Tel: [phone]

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

 

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