REG - Futura Medical PLC - Futura Announces Collaboration with Menarini

Futura MedicalAnnouncement

23/03/2022 07:00

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RNS Number : 6651F  Futura Medical PLC  23 March 2022

 

 

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 report(1) 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
billion(1) 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 (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

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: futuramedical@optimumcomms.com

Tel: +44 (0) 20 3922 0891

 

A. Menarini Korea

Hyeyoung Park, General Manager

Julia Choi, Business Development & Alliance Manager

Email: julia.choi@menariniapac.com (mailto:julia.choi@menariniapac.com)

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
(https://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 (http://www.menariniapac.co.kr)  (in Korean
language) or www.menariniapac.com (http://www.menariniapac.com)

 

 

 

 

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