28 June 2022
Futura Medical plc
("Futura" or the "Company")
· MED3000 received UKCA mark approval as a Class 2A medical device
· Signed five licensing agreements for MED3000 and discussions for additional collaborations ongoing
· FM71 clinical study to complete by early September 2022
· US FDA regulatory submission on track for MED3000 by the end of September 2022 with approval anticipated by end of Q1 2023
· Company board strengthened with the addition of two Non-Executive Directors
Futura Medical plc (AIM: FUM), 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.
MED3000 - Evolving towards commercialisation from a position of strength
2021 was a year of transformational progress for Futura, as the Company achieved major milestones in terms of first regulatory approvals for its lead product, MED3000 - a breakthrough rapid acting topical gel formulation for treatment of erectile dysfunction ("ED") which helps men get an erection within 10 minutes. Additionally, specific regulatory approval for the Great Britain market post-Brexit (UKCA mark) was granted in April 2022. MED3000 has the potential to become the first globally available, clinically proven, OTC treatment for ED.
The Company completed multiple commercial deals for MED3000 in 2021 and 2022, executing upon its strategic plan to leverage commercialisation globally with a network of licensing and distribution partners with brand building strength, healthcare credibility and infrastructure and marketing expertise. In the past year Futura has signed five partnering agreements, mostly recently an agreement with Cooper Consumer Health, a leading European independent self-care organisation, for the European Economic Area, United Kingdom and Switzerland along with previously signed agreements covering Latin America, China and South East Asia, South Korea and the Gulf region including Jordan, Lebanon and Iraq.
A further strategic and critical objective delivered was the appointment of a world class contract manufacturer with the relevant infrastructure, regulatory accreditations and capacity to meet projected demand for MED3000 in all countries including the key markets of the EU, UK and also the USA.
The US remains the largest market opportunity globally for ED treatments OTC and the Company is making steady progress towards completing US Food and Drug Administration ("FDA") regulatory submission for MED3000.
Patient recruitment for the FM71 study (a confirmatory study stipulated by the FDA) completed at the end of 2021 and the clinical study, including patient follow-up, is drawing to a close. The Company remains on track to be able to disclose the results in early September.
A "Human Factors" study was successfully completed in December 2021, with results able to support the regulatory submission for OTC designation, enabling Futura to finalise the OTC product label for the US filing.
The Company looks forward to further updates for shareholders during the remainder of 2022 as Futura prepares for initial launches of MED3000, further commercial agreements and the anticipated US regulatory filing by the end of September 2022.
The impact of COVID-19 on the Company has been limited to date. 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.
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:
Phil Walker/ 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) 203 882 9621
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