TIDMFUM
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(R) 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
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
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(R) technology. Each DermaSys(R)
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(R) 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(R) with
a key claim of "Helps you get an erection within 10 minutes".
Eroxon(R) 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
.
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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END
AGRGPUGWMUPWGQC
(END) Dow Jones Newswires
July 17, 2023 02:00 ET (06:00 GMT)
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