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RNS Number : 8451Q
Futura Medical PLC
24 June 2020
24 June 2020
AGM Statement
-- Regulatory submissions to US FDA and EU Notified Body continue on track
-- Limited impact from COVID-19
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.
Impact of COVID19
The impact of COVID-19 on the Company has been limited to date.
Futura's virtual model has enabled a smooth and effective
transition to home-working for all staff and all of our external
suppliers, including regulatory agencies and laboratories who
continue to operate in line with our expectations and timelines.
Nevertheless, 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.
MED3000 - a topical treatment for Erectile Dysfunction (ED)
-- In December 2019, headline data from the FM57 clinical study
demonstrated that MED3000 has the potential to be a highly
effective, clinically proven, topical treatment for erectile
dysfunction with a rapid onset of action and excellent safety
profile in a $5 billion market.(1)
-- New patent application filed in December 2019 around the
novel effects of the MED3000 formulation shown in FM57 to
potentially provide patent protection until 2040.
-- Regulatory submissions for MED3000 in both Europe and USA are
on track with initial documentation already provided to the
applicable EU Notified Body.
-- We also continue to target submission of the regulatory
dossier to the FDA by the end of Q3 2020 for the USA.
US regulatory activity
-- Initial presentation of existing clinical evidence from the
MED3000 FM57 phase 3 study at an FDA pre-submission meeting on
24(th) February 2020.
-- As disclosed on 6 April 2020, following receipt of the formal
FDA meeting minutes from 24(th) February, the US FDA has agreed to
a De Novo medical device application for MED3000 and invited Futura
to pursue another pre-submission meeting once the Company was in
receipt of the final clinical study report (CSR) for FM57.
-- On 20(th) April it was announced that the company had filed
for a further pre-submission meeting with FDA in the coming months.
This meeting date has now been set with the FDA and will be used to
further discuss clinical sufficiency following completion of FM57's
CSR.
-- If successful, this could lead to a US submission filing by
the end of Q3 2020 to enable FDA review for pre-marketing
clearance.
European regulatory activity
-- In February 2020 Futura commenced formal proceedings for
MED3000 to be approved as a medical device and clinically proven
treatment for ED in Europe by an EU Notified Body (Notified Bodies
are the regulatory authorities that oversees the approval of
medical devices within the EU for all EU countries including the
UK).
-- In order to obtain pre-marketing clearance within the EU, two
requirements have to be met; a Technical Dossier (TD) which
includes sufficient efficacy, safety and quality data and
demonstration that the Company can operate to a high standard of
quality through a Quality Management System (QMS):
o The relevant EU Notified Body has already commenced review of
documentation relating to Futura's QMS
o The TD is nearing completion and will be submitted in due
course when requested by the EU Notified Body
-- The Company has, to date, not experienced any delays with its
chosen EU Notified Body as a result of the introduction of the new
European Medical device regulation nor COVID-19, although this is
being kept under close review.
Tax credit
-- In May 2020, the company received R&D tax credits of
GBP2.22 million from HMRC with respect to the year ending 2019. The
company continues to have sufficient cash resources through to Q2
2021.
_________
(1) Previous market research conducted by Cello Health
Consulting as a prescription product and Ipsos Group as an over the
counter product on MED2005 showed potential peak sales in excess of
US$1 billion. Whilst MED3000 is a slightly different proposition as
it has a different mode of action, it offers the same benefits and
therefore the Group believes that the market potential is
similar
John Clarke, Chairman of Futura Medical, commented: "We have
continued to make good progress with MED3000 regulatory submissions
in both Europe and USA, despite the coronavirus pandemic. Futura's
Board and Executive Team want to thank our employees for their
resilience and adaptability as we have all adjusted, to a virtual
working environment to ensure everyone's health and safety. As a
breakthrough treatment for erectile dysfunction (ED), we remain
confident that we will receive MED3000 approval as a medical device
and look forward to updating the market on Futura's developments
during the remainder of 2020."
-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
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Supriya Mathur
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.
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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