REG - Futura Medical PLC - MED3000 Commercialisation Approval in Saudi Arabia

Futura MedicalAnnouncement

09/08/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230809:nRSI6979Ia&default-theme=true

RNS Number : 6979I  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
value(1), with a reported 10.45%(2) of married males experiencing ED.
 Labatec will hold a launch symposium showcasing Eroxon at the 20
(https://www.uaa2023.org/) (th (https://www.uaa2023.org/) ) Urological
Association of Asia Congress 2023 (https://www.uaa2023.org/) , 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
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9717721/#:~:text=Erectile%20dysfunction%20is%20known%20as,Saudi%20married%20males%20is%2010.45%25.)

-ENDS-

 

 

 

For further information, please contact:

 

Futura Medical plc

James Barder, Chief Executive Officer

Angela Hildreth, Finance Director and COO

Email: investor.relations@futuramedical.com

Tel: +44 (0) 1483 685 670

www.futuramedical.com (http://www.futuramedical.com/)

 

Nominated Adviser and Sole Broker:

 

Liberum

Phil Walker/ Richard Lindley/ Ben Cryer

Tel: +44 (0) 20 3100 2000

 

For media enquiries please contact:

 

Optimum Strategic Communications

Hollie Vile/ Jonathan Edwards/ 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. 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 (http://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
(http://www.futuramedical.com/) .

 

 

 

 

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCUPUMPRUPWGAR