Futura/Haleon Enter US Commercialisation Agreement

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

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.

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For further information, please contact:

Futura Medical plc

James Barder, Chief Executive Officer

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

Tel: [phone]

For media enquiries please contact:

Optimum Strategic Communications

Hollie Vile/ Jonathan Edwards/ Zoe Bolt

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. 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

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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