Futura Medical Regulatory News (FUM)

13 February 2020

Futura provides update on positive EU regulatory discussions and further ongoing analysis of FM57

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, provides an update on positive initial discussions with EU regulators. This follows an extensive internal evaluation of the clinical data from the Phase 3 study ("FM57") announced on 10 December 2019. Futura confirms that it is pursuing the medical device regulatory pathway for its erectile dysfunction (ED) product, which utilised the DermaSys® technology and was used as the control formulation in FM57 and is now known as MED3000.

As previously announced, top line results from FM57 showed that MED3000 has the potential to be a highly effective, clinically proven, topical treatment for erectile dysfunction. MED3000 has a unique evaporative mode of action which the Board believes stimulates nerve endings to cause an erection. As such, it does not require the inclusion of glyceryl trinitrate.

Regulatory Update

On 20 December 2019, the Company announced that it was planning consultations with external regulators to provide clarity on potential timing and further requirements for approval in both the EU and USA.

Following recent positive interactions with 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), Futura yesterday commenced formal proceedings for MED3000, the Company's gel formulation, as a clinically proven treatment for ED to be approved as a medical device. These proceedings will allow the Company to submit its technical file for review by the said Notified Body, including the full clinical study report for FM57 and the Company's Quality Management System in mid 2020.

Feedback from these initial discussions also indicates that MED3000 represents a wider overall commercial opportunity, due to its broader applicability, providing a clinically proven and safe treatment to ED patients as a standalone treatment, including ED patients currently contraindicated from using existing medications such as nitrates, anti-hypertensives, and alpha blockers. An opportunity may also exist with ED patients who might wish to use MED3000 in combination with existing oral ED medications.

Futura also has a confirmed date for a face-to-face meeting with the US FDA, due to take place in Q1 2020, as previously anticipated. This meeting is expected to provide the FDA's opinion on the requirements for the regulatory filing within the USA for MED3000. The Company therefore continues to target mid 2020 for both regulatory submissions in the US and EU, however, will be in a better position to update the timings for filing in the USA following discussions with the US regulators.

DermaSys®

DermaSys® is a proprietary patented transdermal technology platform designed to deliver clinically proven effective pharmaceutical treatments via the skin. This versatile, clear, odourless gel provides effective and local topical application to the required site of action.

MED3000

MED3000 is now the codename for a formulation of DermaSys developed specifically for the treatment of ED that, we now believe, works through an evaporative and unique mode of action which is subject to a new patent application. Initial Company assessments indicate MED3000's combination of volatile solvent components creates an evaporative and novel action that stimulates nerve sensors in the highly innervated glans penis rapidly, leading to smooth muscle relaxation, tumescence and erection.

This was shown to be an extremely effective and safe treatment for ED in FM57. Results demonstrated a highly statistically significant improvement across all ED patient severities than before treatment along with an excellent safety profile. ED patients also experienced a fast onset of action. The product begins to work immediately in some patients, with over 60% of patients seeing onset of their erection within 10 minutes of application. Overall the level of efficacy was broadly equivalent to lower doses of current oral ED treatments and substantially higher than placebo effects typically seen with ED treatments1. In addition, the adverse events were substantially lower than seen with oral ED treatments. This excellent safety profile, together with a rapid speed of onset and high efficacy creates a substantial and highly competitive product opportunity for MED3000.

Futura continues to assess the primary endpoint data for FM57 announced on 10 December 2020 as well as secondary endpoints ahead of the completion of the clinical study report due by the end of April 2020. These ongoing analyses continue to provide us with valuable insights into the data as well as providing a better understanding of the mechanism of action. The glans penis is very highly innervated and there are sensors which are reactive to a range of physical sensations, including touch, pressure and temperature. The Company has conducted initial literature and in vitro based research that has shown the cooling from the evaporation of these specific combinations of solvents, with subsequent warming, following topical application of the MED3000 gel. The Company believes this stimulates the required physical response in order to achieve an erection. The gel is supplied in a small single use tube designed to deliver a dose of 300mg of gel. This amount of gel (approximately the same size as a garden pea) is rubbed into the head (glans) of the penis for 15 seconds to enable the volatile components to evaporate.

The Company intends to provide a full update once it completes its ongoing research and analysis of the FM57 data.

The Company has filed a new patent application which has the potential, if successful, to extend protection until 2040 as well as appointed patent advisors to explore additional Intellectual Property opportunities.

James Barder, Chief Executive Officer, Futura Medical said: "We are encouraged by our initial interactions with the regulators which endorse our early advice and belief that MED3000 will be approved as a medical device with strong clinically proven claims and remain confident that we will be in a position to file in mid-2020 in the EU.

"MED3000 has proven to be a highly effective, safe and differentiated therapy for ED, and FM57 data showed meaningful clinical differences across all ED patient groups, mild, moderate and severe as well as in a pooled analysis across all severities for ED patients - a key evaluation criteria for regulators. Review of all of the study data has been extensive and is continuing and means that the Board now has a better understanding of the mechanism of action. We are conducting additional clinical and literature based research to further support this belief.

"We look forward to providing the market with further updates with regards to timings for filing in the USA following our pre-submission meeting with the US FDA, due to take place in Q1 2020."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

-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/ Hollie Vile

Email: futuramedical@optimumcomms.com

Tel: +44 (0) 203 950 9144

Source

1. Araujo AC et al: The Management of Erectile Dysfunction with Placebo Only: Does it work J Sex Med 6:3440-3448; 2009