TIDMFUM
RNS Number : 0952K
Futura Medical PLC
31 August 2021
31st August 2021
Futura Medical Announces Collaboration to Commercialise MED3000
in key Latin American Markets
Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a
pharmaceutical company developing a portfolio of innovative
products based on its proprietary, transdermal DermaSys(R) 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.
m8 Licensing Agreement
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 billion(1) 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 Q1(3)
.
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
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(R) technology. Each DermaSys(R)
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
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END
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