MED3000 Commercialisation Approval in Saudi Arabia

Futura Medical PLC

09 August 2023

 

9 August 2023

 Futura Medical plc

("Futura" or the "Company")

MED3000 approved for Commercialisation in Saudi Arabia
 under the brand name Eroxon®

Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), the pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology, today announces that its distribution partner Labatec Pharma ("Labatec") has received regulatory approval for MED3000, Futura's innovative topical, gel-based Erectile Dysfunction ("ED") treatment, in the Kingdom of Saudi Arabia.

Labatec will exclusively launch and commercialise MED3000 under the brand name Eroxon®, with initial launch planned in Q4 2023. The manufacturing of Eroxon for the launch has been completed and it will be supported by a full marketing campaign. Saudi Arabia is one of the top ten ED markets in the world by value¹, with a reported 10.45%² of married males experiencing ED.  Labatec will hold a launch symposium showcasing Eroxon at the 20^th Urological Association of Asia Congress 2023, which is being held from 28 September to 1 October in conjunction with the 12^th Emirates International Urological conference in Dubai, United Arab Emirates.

Futura is establishing a growing network of licencing and distribution partners and continues to strengthen its position, with regulatory approval having now been granted in six Middle Eastern countries, including the Kingdom of Saudi Arabia and the United Arab Emirates.  Regulatory approval in the Kingdom of Saudi Arabia closely follows Futura's recent European and UK launch of Eroxon and the FDA's approval of MED3000 in the USA as the first clinically proven gel for the treatment of ED available without a doctor's prescription.

James Barder, Chief Executive Officer of Futura said: "Regulatory approval in the Kingdom of Saudi Arabia paves the way for Eroxon to improve the lives of ED patients in this key market. Eroxon is a game changer in the ED space with its rapid speed of onset helping men get an erection within 10 minutes. This approval comes at a pivotal time for the Company, as we continue to grow and expand the availability of MED3000 globally by building out our licensing and distribution network."

Notes
Sources: ¹ IQVIA ² National Library of Medicine

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For further information, please contact:

Futura Medical plc

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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. 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 conducted two Phase 3 studies using MED3000 in ED; FM57 study which enabled Futura to be granted a CE Mark in 2021 and FM71 which enabled Futura to be granted US marketing authorisation. Both studies demonstrated 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 an 'Over the Counter' classification.

Eroxon® is FDA approved in the US, 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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