MED3000 Collaboration in EEA, UK & Switzerland

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 Manufacturer¹ 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

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: [e-mail]

Tel: [phone]

www.futuramedical.com

Nominated Adviser and Sole Broker:

Liberum

Phil Walker / Richard Lindley / Ben Cryer  / Kane Collings

Tel: [phone]

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile

Email: [e-mail]

Tel: [phone]

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

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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