19 March 2021
Futura Medical Receives Recommendation for Approval of MED3000 from EU Notified Body
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, today announces that the EU Notified Body has successfully completed its review of the Company's Technical Dossier for MED3000 with a recommendation to certificate MED3000 as a Class 2B approved medical device. Once the certificate is received, Futura's breakthrough, topical gel formulation MED3000, will become the first pan-European topical treatment for erectile dysfunction ("ED") available without the need of a doctor's prescription.
As announced previously, Futura had submitted the Technical Dossier for MED3000 for treatment of ED under the European Medical Device Regulation for marketing approval in Europe by an EU Notified Body. European approval for MED3000 will be final upon issuance of a Medical Device Regulation certificate by the panel which is expected before the end of May.
Once EU certification and the resultant CE mark is granted, this paves the way for rapid approval in many countries around the world, in regions including the Middle East, Africa, the Far East and Latin America, who allow "fast-track" review based on their recognition of the EU CE mark. The CE marking will also be recognised in the Great Britain1 until 30 June 2023 and in the period leading up to this the Company will secure the new post-Brexit UKCA mark. This will be a streamlined process since it is understood the UK application can bridge to the EU approval.
Futura continues to progress marketing approval for MED3000 in the USA for use as a non-prescription, clinically proven treatment of ED. With respect to the USA, as announced recently, Futura has had a constructive 4th meeting with the FDA to finalise the clinical trial protocol for the required small supplementary study and is awaiting final meeting minutes.
MED3000 has the potential to be a highly differentiated product by addressing significant unmet needs, across all patient severities in the $5.6 billion global ED market. As such it has the potential to become the first globally available, clinically proven, over the counter ("OTC") treatment for erectile dysfunction. The prevalence of ED disrupts the lives of at least 1 in 5 men globally, with around 23 million men in the US and 20 million men in the UK, France, Italy and Germany. There has been little innovation in ED treatments for over ten years and many patients continue to suffer dissatisfaction with existing treatments.
In conjunction with the regulatory processes, Futura has been working with retained specialised corporate advisers on active commercial discussions with potential licensing and marketing partners.
Following the Company's recent announcement of a Joint Collaboration agreement for the China and the South East Asia region, partnering discussions for other countries continue in line with the agreed process being managed by Futura's corporate advisers. The Company has now received initial offers from a number of parties and believes the EU approval of MED3000 will assist the Company in its objective of delivering long-term, sustainable value through the licensing of MED3000.
James Barder, Chief Executive of Futura Medical commented: "The recommendation to approve MED3000 in Europe is a huge milestone for Futura in the development of MED3000. We look forward with excitement to bringing MED3000 to patients in Europe as the first, clinically proven treatment for erectile dysfunction that is highly differentiated with its rapid speed of onset. Once the certificate is issued, MED3000 may be marketed throughout the EU without the need of a doctor's prescription subject to any national marketing restrictions. This will represent a significant commercial opportunity."
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014 as amended by The Market Abuse (Amendment) (EU Exit) Regulations 2019. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.
1. Northern Ireland is exempt from these Brexit provisions and will continue to recognize the EU CE mark
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Tel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:
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
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