REG - Futura Medical PLC - Futura/Haleon Enter US Commercialisation Agreement

Futura MedicalAnnouncement

17/07/2023 07:00

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RNS Number : 1348G  Futura Medical PLC  17 July 2023

 

 

 

17 July 2023

 

Futura Medical Announces Agreement With Haleon To Commercialise MED3000 In The
USA

 

Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical
company developing a portfolio of innovative products based on its
proprietary, transdermal DermaSys® drug delivery technology, focused on
sexual health, today announces that it has entered into a ground breaking
licensing agreement with Haleon plc ("Haleon"), a world leading consumer
healthcare Company for the rights to exclusively commercialise the Company's
innovative topical, gel-based Erectile Dysfunction ("ED") treatment MED3000,
in the USA.

 

Commercial Highlights:

·      Futura to receive:

o  an initial upfront payment of $4 million;

o  royalty payments on all sales of MED3000 by Haleon; and

o  potential commercial and performance-driven sales milestone payments
totalling between $5 million and $45 million payable over the course of
several years

·      Haleon is responsible for the future launch and ongoing
regulatory, development, marketing, and commercialization of MED3000 in the
USA.  Further details will be disclosed in due course

·      Upon launch, MED3000 will represent the first OTC topical gel
indicated for the treatment of ED

 

Haleon Licensing Agreement

Under the terms of the agreement Haleon will commercialise MED3000 as the
first and only clinically proven gel treatment for ED, available without the
need for a doctor's prescription ("OTC") in the USA, the biggest consumer
healthcare market globally.

 

Haleon will be responsible for all investment and activities related to the
launch and marketing of the product in the USA. Futura will provide ongoing
technical support for OTC product development and commercialisation
opportunities.

 

The prevalence of ED disrupts the lives of at least 1 in 5 men globally with
around 22 million men suffering ED in the USA, making the US market the
largest ED market in the world. The majority of ED sufferers in the USA do
not currently treat their condition. MED3000 will meet the needs of many of
these ED sufferers by providing a safe, effective and fast-acting treatment
that can be purchased without a prescription.

 

MED3000 has previously been approved as the first pan-European clinically
proven topical treatment for ED available OTC and is now available in Belgium
and the UK.

 

James Barder, Chief Executive of Futura Medical, said: "This agreement, with
one of the world's leading global consumer healthcare companies represents a
major milestone for Futura, following on from our recent US FDA approval for
MED3000 as the first OTC topical gel approved for ED. The USA is the largest
ED market in the world and we believe Haleon, with its strong capabilities in
brand-building and marketing through an unrivalled breadth of channels, as
well as its connections and market reach makes it the ideal partner to
introduce MED3000 to the millions of ED suffers in the USA who will soon be
able to buy MED3000 in US pharmacies, without the need for a doctor's
prescription."

 

Commercial Transaction Advisors

JSB Partners served as an adviser to Futura Medical in this transaction

www.jsb-partners.com (http://www.jsb-partners.com)

 

The information communicated in this announcement contains inside information
for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014
as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.

 

-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 USA, 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/) .

 

About Haleon plc

Haleon (LSE / NYSE: HLN) is a global leader in consumer health, with a purpose
to deliver better everyday health with humanity. Haleon's product portfolio
spans five major categories - Oral Health, Pain Relief, Respiratory Health,
Digestive Health and Other, and Vitamins, Minerals and Supplements (VMS). Its
long-standing brands - such as Advil, Sensodyne, Panadol, Voltaren, Theraflu,
Otrivin, Polident, parodontax and Centrum - are built on trusted science,
innovation and deep human understanding.

 

For more information, please visit www.haleon.com

 

 

 

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