Futura Medical Regulatory News (FUM)

24 June 2020

AGM Statement

· Regulatory submissions to US FDA and EU Notified Body continue on track

· Limited impact from COVID-19

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 John Clarke, Non-Executive Chairman, will provide the following update at the Company's Annual General Meeting ("AGM") which is being held at 10:00 am BST later today.

Impact of COVID19

The impact of COVID-19 on the Company has been limited to date. Futura's virtual model has enabled a smooth and effective transition to home-working for all staff and all of our external suppliers, including regulatory agencies and laboratories who continue to operate in line with our expectations and timelines. Nevertheless, the safety of our employees, third-party suppliers and partners remains our primary concern, and we have continued to follow the government guidance in regions in which we operate.

MED3000 - a topical treatment for Erectile Dysfunction (ED)

· In December 2019, headline data from the FM57 clinical study demonstrated that MED3000 has the potential to be a highly effective, clinically proven, topical treatment for erectile dysfunction with a rapid onset of action and excellent safety profile in a $5 billion market.1

· New patent application filed in December 2019 around the novel effects of the MED3000 formulation shown in FM57 to potentially provide patent protection until 2040.

· Regulatory submissions for MED3000 in both Europe and USA are on track with initial documentation already provided to the applicable EU Notified Body. 

· We also continue to target submission of the regulatory dossier to the FDA by the end of Q3 2020 for the USA.

US regulatory activity

· Initial presentation of existing clinical evidence from the MED3000 FM57 phase 3 study at an FDA pre-submission meeting on 24th February 2020.

· As disclosed on 6 April 2020, following receipt of the formal FDA meeting minutes from 24th February, the US FDA has agreed to a De Novo medical device application for MED3000 and invited Futura to pursue another pre-submission meeting once the Company was in receipt of the final clinical study report (CSR) for FM57.

· On 20th April it was announced that the company had filed for a further pre-submission meeting with FDA in the coming months. This meeting date has now been set with the FDA and will be used to further discuss clinical sufficiency following completion of FM57's CSR.

· If successful, this could lead to a US submission filing by the end of Q3 2020 to enable FDA review for pre-marketing clearance.

European regulatory activity

· In February 2020 Futura commenced formal proceedings for MED3000 to be approved as a medical device and clinically proven treatment for ED in Europe by an EU Notified Body (Notified Bodies are the regulatory authorities that oversees the approval of medical devices within the EU for all EU countries including the UK).

· In order to obtain pre-marketing clearance within the EU, two requirements have to be met; a Technical Dossier (TD) which includes sufficient efficacy, safety and quality data and demonstration that the Company can operate to a high standard of quality through a Quality Management System (QMS):

o The relevant EU Notified Body has already commenced review of documentation relating to Futura's QMS

o The TD is nearing completion and will be submitted in due course when requested by the EU Notified Body

· The Company has, to date, not experienced any delays with its chosen EU Notified Body as a result of the introduction of the new European Medical device regulation nor COVID-19, although this is being kept under close review.

Tax credit

· In May 2020, the company received R&D tax credits of £2.22 million from HMRC with respect to the year ending 2019. The company continues to have sufficient cash resources through to Q2 2021.

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1 Previous market research conducted by Cello Health Consulting as a prescription product and Ipsos Group as an over the counter product on MED2005 showed potential peak sales in excess of US$1 billion. Whilst MED3000 is a slightly different proposition as it has a different mode of action, it offers the same benefits and therefore the Group believes that the market potential is similar

John Clarke, Chairman of Futura Medical, commented: "We have continued to make good progress with MED3000 regulatory submissions in both Europe and USA, despite the coronavirus pandemic. Futura's Board and Executive Team want to thank our employees for their resilience and adaptability as we have all adjusted, to a virtual working environment to ensure everyone's health and safety. As a breakthrough treatment for erectile dysfunction (ED), we remain confident that we will receive MED3000 approval as a medical device and look forward to updating the market on Futura's developments during the remainder of 2020."

-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