MED3000 commercial and US regulatory update

RNS Number : 8827S

Futura Medical PLC

14 March 2023

 

14 March 2023

  Futura Medical plc

("Futura" or the "Company")

Futura confirms initial launch of MED3000 under the Eroxon® brand
and continued progress towards regulatory approval in US

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, today provides updates on commercial and US regulatory activities for MED3000, Futura's novel, topical gel formulation for the treatment of erectile dysfunction ("ED") .

Eroxon launch

In May 2022, Futura announced an exclusive licensing agreement with Cooper Consumer Health , a leading International independent self-care organisation for the rights to commercialise MED3000 throughout the EEA, the United Kingdom and Switzerland.

Futura is pleased to report that MED3000, under the brand name Eroxon™ is now available online in Europe. On the 1st of April 2023 Eroxon will also be available in retail pharmacies in Belgium supported by an advertising and promotional campaign. Futura also confirms that further country launches, supported by advertising and promotional campaigns, remain on track during the coming months, as previously guided.

FDA Update

I n October 2022 Futura filed an application for US marketing authorisation for the MED3000 medical device via the De Novo regulatory pathway which is undergoing detailed review. As a regular part of its review process, FDA have asked some additional questions and requested some non-clinical confirmatory data. The company expects to provide a full response to FDA's questions as well as the requested confirmatory data no later than the end of March 2023, to enable FDA to complete their review.

Based on FDA's published target review period guidelines to include time to review the newly provided information, grant of the De Novo request is now expected to be achieved in Q2 2023.

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 US approval and OTC status for MED3000 continues to be a top priority given its potential to be the first OTC clinically proven treatment for ED in the region.

James Barder, Chief Executive Officer of Futura Medical said: "We are pleased to confirm the online debut of Eroxon® with the product now available in Europe.  This will be followed shortly by the first country-specific  retail pharmacy launch supported by an advertising and promotional campaign.  We are in constructive active dialogue with the FDA and believe we are making solid progress in our efforts to be granted OTC marketing authorisation for MED3000 by the FDA which is now anticipated in Q2 2023."

ENDS

For further information please contact:

Futura Medical plc

James Barder, Chief Executive Officer

Angela Hildreth, Finance Director and COO

Email: [e-mail]

Tel: [phone]

www.futuramedical.com

Nominated Adviser and Sole Broker:

Liberum

Phil Walker / Richard Lindley / Ben Cryer 

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For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile/ Zoe Bolt

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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 novel treatment for erectile dysfunction ("ED") through a unique evaporative mode of action. Futura has previously conducted an initial Phase 3 study using MED3000 in ED, referred to as "FM57" which enabled Futura to be granted a CE Mark in 2021. A second confirmatory Phase 3 clinical study, "FM71" was also conducted to support Futura's regulatory submission to the FDA with 96 ED patients and endpoints at 24 weeks, demonstrating that MED3000 presents an effective clinically proven treatment for ED with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for OTC classification.  

Eroxon® is CE marked in Europe and UKCA 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".  Eroxon® is the agreed brand name in certain regions such as the EU whereas MED3000 continues to be the internal code name used by the Company and also in reference to countries where regulatory approval or commercial distribution agreements have not yet been achieved. www.eroxon.com

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

 

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