Futura Medical PLC Futura Confirms Receipt of US FDA Minutes (8130I)
06 Abril 2020 - 1:00AM
UK Regulatory
TIDMFUM
RNS Number : 8130I
Futura Medical PLC
06 April 2020
6 April 2020
Futura Confirms Receipt of US FDA Minutes
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)
technology and currently focused on sexual health and pain, is
pleased to announce that it has received official minutes from the
US Food and Drug Administration (FDA) following its pre-submission
meeting on 24 February 2020.
The Company presented existing clinical evidence from its Phase
3 Study (FM57) and the case for filing for FDA clearance for its
lead product, MED3000, a topical treatment for Erectile Dysfunction
(ED), as a medical device with a De Novo Classification. This
follows top line results from the FM57 study announced in December
2019, that demonstrated that MED3000 has the potential to be a
highly effective, clinically proven, topical treatment for ED, with
a fast onset of action and excellent safety profile.
The minutes confirm the Company's expectations as disclosed in
the Full Year Results 2019, announced on 1 April 2020, that the US
FDA has agreed to a De Novo medical device application subject to
Futura pursuing another pre-submission meeting to further discuss
clinical sufficiency and/or post-marketing requirements once the
clinical study report ("CSR") for FM57 is available. Management
expects this second meeting to take place in the coming months. If
successful, this could lead to a US submission filing in Q3 2020
for FDA review for pre-marketing clearance.
James Barder, Chief Executive of Futura Medical, commented: "We
are very pleased to have received official confirmation of what
will be required to progress MED3000 towards a potential approval
as a medical device as a clinically proven ED therapy. Futura
remains in consultation with the FDA regarding overall data
requirements as we move towards targeted regulatory submissions for
MED3000 in both the US and EU in the next six months .
"The Company also announced in February 2020, following positive
interactions with an EU Notified Body(1) , that it had commenced
formal proceedings for MED3000 in Europe. These proceedings will
allow the Company to submit its technical file for review by the
said Notified Body, including the CSR for FM57 and the Company's
Quality Management System by the end of July 2020. In Europe
medical device applications are typically for Over the Counter
status by default."
Note
1. Notified Bodies are the regulatory authorities that oversee
the approval of medical devices within the EU for all EU countries
including the UK.
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
Bidhi Bhoma/ 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) 203 950 9144
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.
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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