US regulatory and commercial update for MED3000Source: RNS
20 December 2021
Futura Medical plc
("Futura" or the "Company")
Futura provides US regulatory and commercial update for MED3000
Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products for sexual health and pain relief, is pleased to provide an update on good progress with its regulatory and commercial activities for MED3000.
MED3000 is the Company's breakthrough, topical gel formulation for treatment of erectile dysfunction ("ED"). It has the potential to become the first globally available, clinically proven, over the counter ("OTC") treatment for erectile dysfunction and has already been approved as the first pan-European topical treatment for ED available without the need of a doctor's prescription. The USA market is the largest ED market globally and the company's objective of OTC status for MED3000 continues to be a top priority given its potential to be the first OTC clinically proven treatment for ED.
US regulatory process
As previously announced, the FDA has agreed that an application may be made for MED3000 as a medical device for ED treatment, with a De Novo classification. Multiple productive and positive pre-submission meetings were held with the FDA during 2020 and 2021 to discuss existing Phase 3 clinical data, pathway to OTC status and any additional clinical and non-clinical requirements.
The FDA required an additional 6-month confirmatory clinical study, known as "FM71", with MED3000 taking a "least burdensome approach", as well as a short, non-clinical, "Human Factors" study to test the ability of subjects to self-diagnose their ED, correctly select the product based on label information and test subject's ability to correctly use the product without supervision of a doctor. The FDA asked for a minimum of 15 subjects to complete the study.
The "Human Factors" study has been successfully completed with 32 subjects entering the study. It was demonstrated that individuals are able to correctly self-diagnose ED and to make correct self-selection decisions by considering their own health history and the instructions for use and warnings on the label. Overall, there was a very high degree of comprehension of the label and leaflet to increase confidence that the product will be used appropriately in an OTC setting. These results therefore support the regulatory submission for OTC designation and enable Futura to finalise the OTC product label for a US filing.
US confirmatory clinical study, FM71
FM71 is a confirmatory clinical study with MED3000 designed to provide supplementary 6-month efficacy data with a "least burdensome" approach and modest cost. In September 2021 Futura announced that the first patient had entered pre-screening in FM71.
Just over 100 patients have now been successfully enrolled into the study, including a mix of mild, moderate and severe ED sufferers with patients recruited from Eastern Europe and African American patients from a leading US medical centre. The Company aims to continue to recruit up to a further ten patients (to allow for any patient drop-outs, a normal feature in any clinical study) before closing recruitment in the next few weeks. Timelines remain on track to enable planned US regulatory submission by the end of Q3 2022, and for targeting US OTC FDA approval of MED3000 in Q1 2023.
MED3000 commercialisation and manufacturing
2021 saw the Company enter into several commercial licensing deals in large markets for ED in regions such as China and South East Asia, Latin America and the Middle East.
Futura is in advanced discussions for other commercial out-licensing agreements covering additional major regions and countries of the world with multiple interested parties. The Company looks forward to providing further updates in 2022.
Scale-up of manufacturing and production capacity to meet projected demand continues to progress well as Futura works towards an initial launch of MED3000 in certain countries in 2022.
James Barder, Chief Executive of Futura Medical commented: "We are continuing to make good progress with the regulatory process for MED3000 in the US. We are also executing upon our strategic plans to leverage commercialisation globally with a network of licensing and distribution partners with brand building strength, healthcare credibility and regional infrastructure and marketing expertise. 2021 has been a year of transformational progress for Futura and we are excited to be bringing more patients across the globe an accessible, new treatment option for their ED. We look forward to further updates for shareholders during what we believe will be an exciting 2022 for Futura. In the meantime we wish all our shareholders and staff a happy festive season."
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/ Ben Cryer/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile/ Zoe Bolt
Tel: +44 (0) 20 3922 0891
Notes to editors:
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 clinically 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