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Pin to quick picksFutura Medical Regulatory News (FUM)

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Pre-launch of MED3000 ahead of H1 2023 launch

26 Jan 2023 07:00

RNS Number : 8764N
Futura Medical PLC
26 January 2023
 

 

 26 January 2023

 Futura Medical plc

("Futura" or the "Company")

 

Pre-launch of MED3000 Eroxon™ ahead of H1 2023 launch

 

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, announces that its partner, Cooper Consumer Health ("Cooper") has initiated pre-launch activities ahead of the launch of MED3000 (Eroxon™), Futura's breakthrough, topical gel formulation for the treatment of erectile dysfunction ("ED").

 

In May 2022, Futura announced an exclusive licensing agreement with Cooper, 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 confirm that Cooper is on track to launch Eroxonin the first half of 2023, as previously guided, and has already commenced pre-launch activities and expects the first product supplies to be available in the coming months.

 

James Barder, Chief Executive Officer of Futura Medical said: "As part of our close strategic partnership with Cooper, we are pleased to note that as planned, Eroxon will soon be made available to men suffering from ED, especially those with mild and moderate ED, to improve their erectile performance in a fast, safe, effective and accessible way. We look forward to updating the market further in due course."

 

MED3000 is 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.

 

Futura has established a network of licensing and distribution partners with strength in brand building, pharmaceutical credibility and regional infrastructure and marketing expertise for long-term distribution of MED3000 Eroxon™ across the globe.

 

To date, Futura has signed commercial agreements in key markets including; European Economic Area (EEA), the United Kingdom, the Gulf Co-operation Council (GCC) region, Switzerland and South Korea, and now has a strong and expanding distribution platform in place for regions outside the key US market. As announced in December Futura's corporate advisors formally commenced the search for a US commercial partner and continue to be engaged in a number of ongoing discussions.

 

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

 

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

 

About Cooper Consumer Health Group (CCH)

Cooper Consumer Health Group (CCH) is the largest independent selfcare organization in Europe that is active in the OTC consumer healthcare market with the development, manufacturing, selling and marketing of selfcare products (e.g., medicines, medical devices, cosmetics, biocides and food supplements) under its own or licensed brands.

The ambition of our group is to offer selfcare solutions to everyone based on a European brands portfolio. CCH has proven its capacity to integrate new activities and aggregate talents by capitalising on the strengths and the structure of its group. www.cooper-healthcare.com

 

 

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.
 
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