TIDMFUM
RNS Number : 2204D
Futura Medical PLC
28 June 2021
28 June 2021
Futura Medical plc
("Futura" or the "Company")
AGM Statement
-- MED3000 CE mark approved for marketing in Europe and UK
-- Commercialisation of MED3000 continues at pace with China and
South East Asia partnered and discussions for other countries
ongoing
-- Regulatory submission to US FDA continues on track
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, is pleased to announce that John Clarke, Non-Executive
Chairman, will provide the following update at the Company's Annual
General Meeting ("AGM") which is being held at 10:00 am BST later
today.
MED3000 - a topical treatment for Erectile Dysfunction
("ED")
MED3000 has CE mark approval in Europe for treatment of ED in
adult men. This paves the way for approval in many countries around
the world, including in the Middle East, Africa, the Far East and
Latin America, which are regions which allow "fast-track" review
based on recognition of the CE mark.
For the US, planning and preparation activities such as active
site recruitment are well underway for the start of FM71, the
confirmatory study to be conducted prior to formal regulatory
submission to FDA as a DeNovo Medical Device. Trial start is on
schedule with first patient dosing expected Q3 2021.
Securing manufacturing capacity and flexibility to scale up
production of MED3000 to meet projected demand is also a clear
focus for the Board and management.
Futura's first licensing deal announced in Q1 was a joint
collaboration agreement for China and South East Asia with 50/50
share of profits between Futura and its Asian partner designed to
capture long term value for the Company.
These validating milestones are driving progress on active
commercial discussions with potential licensing and marketing
partners. Discussions are moving forward with a number of other
parties for licensing rights for MED3000 in other regions and we
continue to target concluding a number of deals in the coming
months.
COVID-19
The impact of COVID-19 on the Company has been limited to date.
The safety of our employees, third-party suppliers and partners
remains our primary concern, and we have continued to follow the
government guidance in regions in which we operate.
John Clarke, Chairman of Futura Medical, commented: "The
licensing agreement and financing activities in H1 2021 have given
the Company significant momentum. Futura is rapidly advancing
MED3000, looking to capture long term value and working towards
creating a Company with substantial revenue streams. We thank all
our shareholders for supporting the Company as well as employees
and partners for their commitment and hard work. MED3000 is a
breakthrough treatment for erectile dysfunction (ED), approved in
Europe as a medical device. We have a first, commercial agreement
in place for China and South East Asia. Our outlook for further
deals is optimistic and we look forward to updating the market on
Futura's developments during the remainder of 2021. The team is
laser-focused on preparation and execution of the confirmatory
clinical study and the non-clinical study to finalise an OTC label
for the regulatory submission for MED3000 in the US which the
Company aims to achieve in 2022."
-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
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END
AGMUVSVRANUNUAR
(END) Dow Jones Newswires
June 28, 2021 02:00 ET (06:00 GMT)
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