23 March 2022

  Futura Medical plc

("Futura" or the "Company")

Futura Announces Collaboration with Menarini Korea

 to Commercialise MED3000 in South Korea

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 and currently focused on sexual health and pain, today announces it has entered into a licensing agreement with A. Menarini Korea Limited ("Menarini Korea"), a wholly owned subsidiary of Menarini Group, for the exclusive rights to commercialise the Company's topical, gel-based Erectile Dysfunction ("ED") treatment MED3000 in South Korea.

Commercial Highlights:

·      Futura is eligible to receive an initial upfront payment

·      Menarini Korea to pay an agreed price to Futura for the manufacture and supply of MED3000 by Futura's   Contract Manufacturing Organisation ("CMO")

·      Menarini Korea is responsible for all local MED3000 development, regulatory approvals, product launch   and marketing.

Menarini Korea, a wholly owned subsidiary of A. Menarini Asia-Pacific Holdings PL based in Seoul Korea, is part of the world's largest Italian biopharmaceutical company with a heritage of over 135 years and over 17,500 employees in more than 140 countries.  Menarini Korea possesses the capability to successfully register, launch and commercialise brands in the market, with key strengths in therapeutic areas such as Cardiovascular, Hemato-Oncology/Pain, Men's Health, Consumer Health, and Specialty/Orphan diseases.

Menarini Licensing Agreement

Under the terms of the agreement, Futura will support Menarini to gain marketing authorisation and in commercialising MED3000 as a clinically proven treatment for ED in South Korea.

Menarini will be responsible for all costs related to the regulatory approval and marketing of the product in the region, including a clinical bridging study if necessary. Futura will provide reasonable technical support for product development and commercialisation and will receive an upfront payment and provide manufactured product from Futura's contract manufacturing organisation.

James Barder, Chief Executive of Futura commented: "We are delighted to have reached an agreement with a prestigious company that operates in a key Asian market such as South Korea. Menarini is a trusted partner in the region that is perfectly situated to market retail products, with local teams that have deep understanding and experience of the South Korean market as well as significant expertise and a track record in rapidly registering and launching new products. We look forward to collaborating closely with the team at Menarini.

"Futura is continuing to build a strong and specialist distribution network for MED3000 across the globe and we are particularly focused on covering the key, top 15 markets for ED especially where the product already has been granted regulatory approval. We look forward to providing further updates on commercialisation as soon as possible."

Hyeyoung Park, General Manager of A. Menarini Korea commented: "The commercialisation agreement to license-in Futura's MED3000 is a significant milestone for enhancing Menarini's Men's Health portfolio in South Korea. According to the Korean Urological Association's report¹ on Erectile Dysfunction patients in South Korea, there are approximately 2.3 million men suffering from ED in the region, including patients with underlying etiology. MED3000 has been clinically studied for its onset speed and safety profile and has the potential to be a meaningful treatment option for Korean ED patients. Based on our extensive reach to physicians, multi-channel marketing capabilities, strong core values, and established track record in product launch, we are confident in generating significant value and long-term sustainable growth for both Futura and Menarini.

"The global ED prescription market is estimated to be in excess of US$3 billion¹ amongst the leading 15 markets with volumes growing in the past year by 8%.  The USA ranked 1st and Korea ranked 9th in terms of value and measured by volume, Brazil is ranked 1st, USA 2nd, and Korea 6th. The UK is ranked 9th and 14th measured by value and volume, respectively."

1. Source: http://www.docdocdoc.co.kr/news/articleView.html?idxno=214357

2. Source: IQVIA IMS Health 2020

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: [email protected] 

Tel: +44 (0) 1483 685 670

www.futuramedical.com

Nominated Adviser and Sole Broker:
Liberum
Richard Lindley/ Phil Walker/ Kane Collings
Tel: +44 (0) 20 3100 2000

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile/ Zoe Bolt

Email: [email protected]

Tel: +44 (0) 20 3922 0891

A. Menarini Korea

Hyeyoung Park, General Manager  

Julia Choi, Business Development & Alliance Manager

Email: [email protected]

Tel: +82 (2) 2037 7300, +82 (2) 2037 7386  

www.menariniapac.co.kr

Notes to editors

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 A. Menarini Asia-Pacific

In Asia-Pacific, Menarini's vision is to be a leading provider of important healthcare brands to improve the lives of people in the region. Menarini Asia-Pacific operates across the entire commercial value chain, from clinical development, regulatory approval and product launch to lifecycle management with a diverse portfolio of proprietary and partnered brands in key therapeutic fields, including Consumer Health, Dermatology, Allergy/Respiratory, Gastroenterology, Cardio-metabolic, Anti-infectives, Oncology/Specialty Care and Men's Health.

For more information about A. Menarini Korea or Menarini Asia-Pacific, please visit: www.menariniapac.co.kr (in Korean language) or www.menariniapac.com