30 April 2021
Futura Medical Receives Approval from EU Notified Body for MED3000
Breakthrough, fast acting topical gel formulation MED3000 becomes Europe's first approved clinically proven, topical treatment for erectile dysfunction available without the need of a doctor's prescription
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 further to the announcement of 19 March 2021, the Company has now received its MDR EU Quality Management Certificate for the placing on the market of a Class II(b) medical device known as MED3000 ("CE mark approval").
Futura's breakthrough, fast acting topical gel formulation MED3000, is the first clinically proven, pan-European topical treatment for adult men with erectile dysfunction ("ED") available without a doctor's prescription ("OTC").
Studies have shown MED3000 to be an extremely effective treatment for ED with an excellent safety profile. MED3000 has a unique evaporative mode of action which the Company believes stimulates nerve endings in the glans penis to cause an erection. MED3000 helps men get an erection within 10 minutes, substantially faster than oral tablet phosphodiesterase-5 inhibitors (PDE5i's), with significant benefits for spontaneous rather than pre-planned sexual intercourse.
The CE mark approval of MED3000 from the EU Notified Body paves the way for approval in many countries around the world, including in the Middle East, Africa, the Far East and Latin American regions which allow "fast-track" review based on recognition of the EU CE mark. Due to post-Brexit arrangements, the EU CE mark can be used to market the product in Great Britain until 30 June 2023 by which time a specific UKCA mark has to be obtained. This will be a streamlined process since it is understood the UK application can bridge to the EU approval.
Manufacturing scale up and commercial discussions continue to progress well and the Company looks forward to updating shareholders further in the coming months.
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.
James Barder, Chief Executive of Futura Medical commented: "Today marks a transformational milestone for the Company. We are excited to be able to offer MED3000 to millions of patients in Europe as the first, clinically proven OTC treatment for erectile dysfunction. MED3000 is a highly differentiated product, with a rapid speed of onset addressing significant unmet needs, across all patient severities in the $5.6 billion global ED market. We look forward to further MED3000 marketing approvals in the coming years in multiple regions across the world, including the USA and Asia."
Professor David Ralph, Consultant Urologist at University College London and past president of the European Society of Sexual Medicine commented on the approval: "The efficacy of MED3000 is remarkable and approaches the efficacy of current first line therapy but with significantly lower adverse events. With topical application, it will be of particular appeal to patients who want a fast onset of action. Lack of drug interactions with prescription products will enable the product to be used with other medications such as nitrates and other cardiovascular drugs. It can also potentially be used in conjunction with other ED products to improve overall efficacy to patients. As such the product will be of great interest to the medical community."
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.
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. MED3000 is CE marked in Europe and the UK as a clinical proven topical treatment for adult men with erectile dysfunction.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com