MEXICO CITY, Aug. 31, 2021 /PRNewswire/ -- 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 m8 Pharmaceuticals, Inc
("m8"), a specialty biopharmaceutical company focused on
commercialisation in Latin
America, for the rights to exclusively develop and
commercialise the Company's topical, gel-based Erectile Dysfunction
("ED") treatment MED3000, in Brazil and Mexico.
Commercial Highlights:
- Futura to receive payments on all sales of MED3000 from m8
- Futura also eligible to receive up to $8.5 million in milestone payments based on
deliverable sales volumes, including a small initial upfront
payment
- m8 is responsible for all local MED3000 development and
regulatory costs in Brazil and
Mexico as well as marketing
expenses and ongoing pharmacovigilance and safety within the
region
m8 is a specialty biopharmaceutical company, headquartered and
incorporated in the USA and
focused on licensing, marketing and distributing innovative and
established therapeutics in the two largest Latin America markets: Brazil and Mexico.
Under the terms of the agreement Futura and m8 will work
together to gain marketing authorisation and commercialise MED3000
as a clinically proven treatment for ED available without the need
for a doctor's prescription ("OTC") in Brazil and Mexico, the two biggest countries and
healthcare end markets in Latin
America. The agreement is for an initial term of 15
years.
m8 will be responsible for all costs related to the regulatory
approval and marketing of the product. m8 and Futura believe the EU
(inclusive of the UK) approval of MED3000 granted in April 2021 will facilitate approval in
Brazil, Mexico and other countries within Latin America without the need for further
clinical development. Futura will provide reasonable ongoing
technical support for OTC product development and
commercialisation. Futura will receive payments on all sales of
MED3000 from m8, and up to four milestone payments totalling
$8.5 million based on cumulative
sales volumes within the initial term.
James Barder, Chief Executive
of Futura Medical commented: "We are excited to be entering
into this agreement with m8 to expand MED3000's market reach to
Brazil and Mexico, both significant markets for ED. We
are very pleased to have a partner with m8's dedicated launch,
brand-building and marketing experience as well as resources and
strong pharmaceutical connections in Latin America. We look forward to working
closely with their team."
Joel Barlan, Chief Executive
Officer of m8 commented: "We are
pleased to license Futura's MED3000, bringing their clinically
validated technology to Latin
America. We feel that MED3000 could significantly benefit
individuals suffering from ED in the region, generating significant
value and long term sustainable growth for both Futura and m8 in
the process. Our mission at m8 is to continue to positively impact
lives and improve the health of patients by making innovative and
effective therapies accessible to the Latin American
population."
The global ED prescription market is estimated to be
approximately US$5
billion1 amongst the leading 15 markets, with the
USA ranked first and Brazil and Mexico ranked second and eighth respectively
in value terms. Brazil,
Mexico and neighbouring countries
in Latin America represent a
significant opportunity as the economies of these countries
continue to outstrip the economic growth of many Western economies.
Brazil and Mexico together account for 63% of the
region's pharmaceutical market and reached growth rates of 10.3%
and 7.3% respectively from 2019 to 2020 Q13.
1. Source: IQVIA IMS Health 2018
2. Source: Global Data Epidemiological Analysis
2020
3. Source: IQVIA Pharmaceutical Market Trends in LATAM,
June 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: investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
www.futuramedical.com
M8 Pharmaceuticals
Joel Barlan
Chief Executive Officer
T: +52 (55) 4431 2933
us.wm@moksha8.com
Rafael Ferrer
Vice President of Corporate Development
T: +1 (305) 299 6998
Rafael.ferrer@moksha8.com
Nominated Adviser and Sole Broker:
Liberum
Richard
Lindley/ Euan Brown/ 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
Tel: +44 (0) 20 3922 0900
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 M8 Pharmaceuticals
m8 is a specialty
biopharmaceutical company focused on licensing, marketing and
distributing innovative and established therapeutics in the two
largest Latin America markets:
Brazil and Mexico. m8 aims to become the preferred
pharmaceutical partner for the licensing of high-value innovative
and proven therapies across our main therapeutic areas CNS,
Respiratory, Cardiometabolic, Rheumatology, Gastroenterology,
Onco-hematology and Orphan Diseases. m8 is a Montreux Equity
Partners portfolio company.
For more information, please visit: www.moksha8.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/m8-pharmaceuticals-announces-license-of-exclusive-rights-med3000-from-futura-medical-for-latin-america-301365521.html
SOURCE m8 Pharmaceuticals