REG - Futura Medical PLC - MED3000 Collaboration in EEA, UK & Switzerland

Futura MedicalAnnouncement

23/05/2022 07:00

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RNS Number : 3503M  Futura Medical PLC  23 May 2022

 

 

 

23 May 2022

 

 Futura Medical plc

("Futura" or the "Company")

Futura Announces Collaboration with Cooper Consumer Health to Commercialise
MED3000 in EEA, United Kingdom and Switzerland

 

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, today
announces it has entered into an exclusive licensing agreement with Cooper
Consumer Health  ("Cooper"), a leading European independent self-care
organisation, for the rights to commercialise the Company's topical, gel-based
Erectile Dysfunction ("ED") treatment MED3000, throughout the European
Economic Area, United Kingdom and Switzerland.

 

Commercial Highlights:

·     Futura eligible to receive initial upfront payments, as well as
undisclosed cumulative sales milestone payments

·     Cooper to pay an agreed price to Futura for the manufacture and
supply of MED3000 by Futura's third party contractors

·     Cooper will be responsible for all launch and marketing expenses

·     Initial licence agreement term of five years. This complies with EU
competition law that limits deal terms to five years

 

Cooper, based in Paris, France is an international independent selfcare
organisation with main presence in Europe that is active in the Over the
Counter ("OTC") consumer healthcare market with the development,
manufacturing, selling and marketing of a diverse range of selfcare products
(e.g medicines, medical devices, biocides, cosmetics and food supplements)
under its own or licensed well-known brands.

 

Cooper Licensing Agreement

Under the terms of the agreement, Cooper will commercialise MED3000 in the
EEA, United Kingdom and Switzerland as a clinically proven, safe and
fast-acting treatment for ED available without the need for a doctor's
prescription.

 

Futura will receive an initial upfront payment, as well as undisclosed
cumulative sales milestone payments and will manufacture and supply the
product (through its 3(rd) party contract manufacturers) for the EEA, United
Kingdom and Switzerland to Cooper. The agreement is for an initial term of
five years complying with EU competition law.  Futura will remain Legal
Manufacturer(1) and be responsible for supply of MED3000 through its 3(rd)
party contract manufacturers.

 

MED3000 is Futura's breakthrough, topical gel formulation for treatment of ED.
 It has the potential to become the first globally available, clinically
proven, OTC treatment for ED and has already been approved as Medical Device
Class IIb according to MDR regulation. Additionally, specific regulatory
approval for the Great Britain market post-Brexit was granted in April 2022.

Consumer In-Use Test

Cooper, as part of its due diligence process, conducted a consumer marketing
Home Use Test ("HUT") in the United Kingdom, France and the Netherlands
whereby individuals self-diagnosed with ED were provided with a four-pack
sample of MED3000. The in-use results were in line with findings published in
2019 in Futura's clinical study FM57 which showed that over two thirds of
patients experienced a clinically meaningful benefit from using MED3000 in a
controlled clinical setting. MED3000 performed well in the real world,
consumer HUT setting, with the majority of men with ED, other than men
suffering from severe ED with significant co-morbidities, seeing an
improvement in erectile performance and underlining the product's potential as
a highly effective, safe, clinically proven, topical treatment for ED.

 

James Barder, Chief Executive of Futura Medical commented: "This is our fifth
commercial agreement for MED3000, and we are excited to be working with
Cooper. Aside from its significant experience and presence within the
healthcare field we believe the close strategic alignment of the two companies
makes this an excellent partnership and we look forward to working closely
together in a long term, profitable and sustainable partnership for both
Futura and Cooper."

 

Bart Meermans, Chief Executive Officer of Cooper commented: "We are very
pleased having signed this partnership agreement with Futura and look forward
to building MED3000 into a strong and novel brand for Cooper. We strongly
believe this highly innovative OTC Medical Device will be able to help many
men with ED, especially those with mild and moderate ED, to improve their
erectile performance in a fast, safe and effective way. ED is an under
reported and under treated condition with far-reaching consequences for men
and their partners. With MED3000 we will be offering an over-the-counter
treatment that is efficacious and well-tolerated, that works within minutes,
is inclusive of the partner and facilitates intimacy for a more spontaneous
sexual experience for both partners."

 

(1) Legal manufacturer means the organisation responsible for the design,
manufacture, packaging and labelling of a device before it is placed on the
market under that organisation's own name, regardless of whether these
operations are carried out by that organisation or on its behalf by a third
party contract manufacturer.

 

 

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 contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulation
(EU) No. 596/2014 as amended by The Market Abuse (Amendment) (EU Exit)
Regulations 2019. Upon the publication of this announcement via the Regulatory
Information Service, this inside information is now considered to be in the
public domain.

 

-ENDS-

For further information please contact:

Futura Medical plc

James Barder, Chief Executive

Angela Hildreth, Finance Director and COO

Email: investor.relations@futuramedical.com
(mailto: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  / Kane Collings

Tel: +44 (0) 20 3100 2000

 

For media enquiries please contact:

 

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile

Email: futuramedical@optimumcomms.com (mailto:futuramedical@optimumcomms.com)

Tel: +44 (0) 203 922 0891

 

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 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,
consistently meeting all co-primary endpoints of IIEF, SEP2 and SEP3
(internationally accepted clinical trial endpoints in ED) with over 60% of
patients experiencing a clinically meaningful improvement in their ED.
 MED3000 also begins to work immediately in some patients, with 60% of
patients seeing onset of their erection within 10 minutes of application.
MED3000 is CE marked in Europe and the UK as a clinically proven
topical treatment for adult men with erectile dysfunction.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market
of the London Stock Exchange. www.futuramedical.com
(https://www.futuramedical.com/)

 

About Cooper

 

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

 

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