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RNS Number : 1431X
Futura Medical PLC
30 April 2021
30 April 2021
Futura Medical Receives Approval from EU Notified Body for
MED3000
Breakthrough, fast acting topical gel formulation MED3000
becomes Europe's first approved clinically proven, topical
treatment for erectile dysfunction available without the need of a
doctor's prescription
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 that further to the announcement of 19 March
2021, the Company has now received its MDR EU Quality Management
Certificate for the placing on the market of a Class II(b) medical
device known as MED3000 ("CE mark approval").
Futura's breakthrough, fast acting topical gel formulation
MED3000, is the first clinically proven, pan-European topical
treatment for adult men with erectile dysfunction ("ED") available
without a doctor's prescription ("OTC").
Studies have shown MED3000 to be an extremely effective
treatment for ED with an excellent safety profile. MED3000 has a
unique evaporative mode of action which the Company believes
stimulates nerve endings in the glans penis to cause an erection.
MED3000 helps men get an erection within 10 minutes, substantially
faster than oral tablet phosphodiesterase-5 inhibitors (PDE5i's),
with significant benefits for spontaneous rather than pre-planned
sexual intercourse.
The CE mark approval of MED3000 from the EU Notified Body paves
the way for approval in many countries around the world, including
in the Middle East, Africa, the Far East and Latin American regions
which allow "fast-track" review based on recognition of the EU CE
mark. Due to post-Brexit arrangements, the EU CE mark can be used
to market the product in Great Britain until 30 June 2023 by which
time a specific UKCA mark has to be obtained. This will be a
streamlined process since it is understood the UK application can
bridge to the EU approval.
Manufacturing scale up and commercial discussions continue to
progress well and the Company looks forward to updating
shareholders further in the coming months.
The prevalence of ED disrupts the lives of at least 1 in 5 men
globally, with around 23 million men in the US and 20 million men
in the UK, France, Italy and Germany. There has been little
innovation in ED treatments for over ten years and many patients
continue to suffer dissatisfaction with existing treatments.
James Barder, Chief Executive of Futura Medical commented:
"Today marks a transformational milestone for the Company. We are
excited to be able to offer MED3000 to millions of patients in
Europe as the first, clinically proven OTC treatment for erectile
dysfunction. MED3000 is a highly differentiated product, with a
rapid speed of onset addressing significant unmet needs, across all
patient severities in the $5.6 billion global ED market. We look
forward to further MED3000 marketing approvals in the coming years
in multiple regions across the world, including the USA and
Asia."
Professor David Ralph, Consultant Urologist at University
College London and past president of the European Society of Sexual
Medicine commented on the approval: "The efficacy of MED3000 is
remarkable and approaches the efficacy of current first line
therapy but with significantly lower adverse events. With topical
application, it will be of particular appeal to patients who want a
fast onset of action. Lack of drug interactions with prescription
products will enable the product to be used with other medications
such as nitrates and other cardiovascular drugs. It can also
potentially be used in conjunction with other ED products to
improve overall efficacy to patients. As such the product will be
of great interest to the medical community."
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) 203 922 0891
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 clinical 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
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