Futura Medical Regulatory News (FUM)

13 December 2022

 Futura Medical plc

("Futura" or the "Company")

Update on a milestone year of regulatory and commercial progress for MED3000

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 provide an update on a pivotal year of regulatory progress and commercial activities for MED3000.

MED3000 is the Company's breakthrough, topical gel formulation for the treatment of erectile dysfunction ("ED") and is approved as the first pan-European topical treatment for ED available without the need of a doctor's prescription and available over the counter ("OTC"). Subject to US Food and Drug Administration ("FDA") granting Marketing Authorisation, MED3000 has the potential to become the first major ED treatment available OTC throughout the USA.

Middle East Regulatory progress

We are pleased to announce that the first marketing authorisation for MED3000 has now been granted in three Middle Eastern countries including the UAE. Further additional approvals are expected as we move into 2023 alongside initial launches, where regulatory approval has been received, under the Eroxon® brand.

US Regulatory progress

In 2021, the FDA requested an additional Phase 3 clinical study, known as "FM71" for MED3000, designed to provide 24-week efficacy and safety data. The study protocol was agreed with the FDA prior to commencing the study in September 2021. Results, announced in August 2022, demonstrated that all primary and secondary endpoints had been met with a highly favourable safety and tolerability profile with no serious adverse events recorded.

Based on these results, Futura filed an application for Marketing Authorization as a De Novo Medical Device in October 2022, presenting the case that MED3000 is an effective clinically proven treatment for ED with a 10-minute onset of action and a favourable benefit versus risk profile ideally suited for OTC classification.

The FDA has now confirmed that the dossier is under formal review and has indicated that the dossier has successfully passed the initial technical screening. Based on the FDA's published target review period guidelines, granting of marketing authorisation remains on track to be achieved by the end of Q1 2023, in line with previously announced timelines.

EU Regulatory progress

In April 2022, Futura obtained the UKCA mark for MED3000 as a Class 2A medical device, required due to post Brexit arrangements, supplementing the EU CE mark obtained in 2021.  

MED3000 commercialisation and launch plans

In the past 18 months, Futura entered into and signed multiple commercial agreements throughout the European Economic Area, the United Kingdom, the Gulf Co-operation Council (GCC) region, Switzerland and South Korea. The Company is continuing to expand its strong network of licensing and distribution partners as it moves towards initial launches of MED3000 in the first half of 2023.

In line with the Board's US commercialisation strategy following the successful completion of FM71 and the FDA dossier submission in October 2022, Futura's corporate advisors have formally commenced the search for a US commercial partner and are engaged in a number of ongoing discussions. The Company looks forward to providing a further update in due course.

As previously reported in September 2022, the first production order of Eroxon® has been received to enable initial launches through its European & UK distribution partner, Cooper Consumer Health and the planned debut of Eroxon® remains on track. In addition, we are also pleased to announce that the first production order for initial launches of Eroxon® in the Middle East, which are planned for 2023, has been agreed through our distribution partner Labatec Pharma.

MED3000 education

In October 2022, Futura attended the joint meeting of the Sexual Medicine Society of North America (SMSNA) and the International Society of Sexual Medicine (ISSM) in Miami. An Advisory Panel meeting comprised of eight world renowned experts in Sexual Medicine from the USA, Europe, UK and Brazil was convened to discuss MED3000's clinical data, its unique mode of action and how it could be used as a treatment alternative for ED. MED3000 was acknowledged by the Advisory Panel as a potential, safe, fast-acting and effective treatment for addressing the medical unmet need of ED via OTC. Two members of the Panel, Professor Hellstrom and Dr Glina recorded their specific thoughts on how MED3000 might be of benefit to patients. The video can be accessed on the Futura Medical website here:

James Barder, Chief Executive Officer, Futura Medical said: "We are delighted with the significant progress we have achieved during 2022 and are looking forward to 2023 which we believe will be a very exciting and pivotal year for the Company with initial launches of Eroxon®, the brand name for MED3000. We remain on track to be granted US marketing authorisation for MED3000 by the end of Q1 2023 as a clinically proven, fast-acting, topical treatment with a highly favourable side effect profile for ED patients, without the need for a doctor's prescription. As we move towards initial launches and strategic scale up of commercialisation of Eroxon® in the first half of 2023, we hope to be able to transform the lives of ED patients around the world with our breakthrough OTC product.

"I would like to thank all our shareholders for supporting the Company, as well as our employees and commercial partners for their commitment and hard work throughout 2022 and we look forward to updating the market on future achievements in 2023."

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

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

Email: futuramedical@optimumcomms.com

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 previously 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, using measures IIEF-EF, SEP2 and SEP3 (internationally accepted clinical trial endpoints in ED) with over 60% of patients experiencing a clinically meaningful improvement in their ED.

MED3000 is CE marked in Europe and CA marked in the UK as a clinically proven topical treatment for adult men with erectile dysfunction under the brand Eroxon™ with a key claim of "Helps you get an erection within 10 minutes".

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com