TIDMFUM
RNS Number : 8373C
Futura Medical PLC
13 February 2020
13 February 2020
Futura provides update on positive EU regulatory discussions and
further ongoing analysis of FM57
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, provides an update on positive initial discussions with EU
regulators. This follows an extensive internal evaluation of the
clinical data from the Phase 3 study ("FM57") announced on 10
December 2019. Futura confirms that it is pursuing the medical
device regulatory pathway for its erectile dysfunction (ED)
product, which utilised the DermaSys(R) technology and was used as
the control formulation in FM57 and is now known as MED3000.
As previously announced, top line results from FM57 showed that
MED3000 has the potential to be a highly effective, clinically
proven, topical treatment for erectile dysfunction. MED3000 has a
unique evaporative mode of action which the Board believes
stimulates nerve endings to cause an erection. As such, it does not
require the inclusion of glyceryl trinitrate.
Regulatory Update
On 20 December 2019, the Company announced that it was planning
consultations with external regulators to provide clarity on
potential timing and further requirements for approval in both the
EU and USA.
Following recent positive interactions with 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), Futura yesterday commenced formal proceedings
for MED3000, the Company's gel formulation, as a clinically proven
treatment for ED to be approved as a medical device. These
proceedings will allow the Company to submit its technical file for
review by the said Notified Body, including the full clinical study
report for FM57 and the Company's Quality Management System in mid
2020.
Feedback from these initial discussions also indicates that
MED3000 represents a wider overall commercial opportunity, due to
its broader applicability, providing a clinically proven and safe
treatment to ED patients as a standalone treatment, including ED
patients currently contraindicated from using existing medications
such as nitrates, anti-hypertensives, and alpha blockers. An
opportunity may also exist with ED patients who might wish to use
MED3000 in combination with existing oral ED medications.
Futura also has a confirmed date for a face-to-face meeting with
the US FDA, due to take place in Q1 2020, as previously
anticipated. This meeting is expected to provide the FDA's opinion
on the requirements for the regulatory filing within the USA for
MED3000. The Company therefore continues to target mid 2020 for
both regulatory submissions in the US and EU, however, will be in a
better position to update the timings for filing in the USA
following discussions with the US regulators.
DermaSys(R)
DermaSys(R) is a proprietary patented transdermal technology
platform designed to deliver clinically proven effective
pharmaceutical treatments via the skin. This versatile, clear,
odourless gel provides effective and local topical application to
the required site of action.
MED3000
MED3000 is now the codename for a formulation of DermaSys
developed specifically for the treatment of ED that, we now
believe, works through an evaporative and unique mode of action
which is subject to a new patent application. Initial Company
assessments indicate MED3000's combination of volatile solvent
components creates an evaporative and novel action that stimulates
nerve sensors in the highly innervated glans penis rapidly, leading
to smooth muscle relaxation, tumescence and erection.
This was shown to be an extremely effective and safe treatment
for ED in FM57. Results demonstrated a highly statistically
significant improvement across all ED patient severities than
before treatment along with an excellent safety profile. ED
patients also experienced a fast onset of action. The product
begins to work immediately in some patients, with over 60% of
patients seeing onset of their erection within 10 minutes of
application. Overall the level of efficacy was broadly equivalent
to lower doses of current oral ED treatments and substantially
higher than placebo effects typically seen with ED treatments(1) .
In addition, the adverse events were substantially lower than seen
with oral ED treatments. This excellent safety profile, together
with a rapid speed of onset and high efficacy creates a substantial
and highly competitive product opportunity for MED3000.
Futura continues to assess the primary endpoint data for FM57
announced on 10 December 2020 as well as secondary endpoints ahead
of the completion of the clinical study report due by the end of
April 2020. These ongoing analyses continue to provide us with
valuable insights into the data as well as providing a better
understanding of the mechanism of action. The glans penis is very
highly innervated and there are sensors which are reactive to a
range of physical sensations, including touch, pressure and
temperature. The Company has conducted initial literature and in
vitro based research that has shown the cooling from the
evaporation of these specific combinations of solvents, with
subsequent warming, following topical application of the MED3000
gel. The Company believes this stimulates the required physical
response in order to achieve an erection. The gel is supplied in a
small single use tube designed to deliver a dose of 300mg of gel.
This amount of gel (approximately the same size as a garden pea) is
rubbed into the head (glans) of the penis for 15 seconds to enable
the volatile components to evaporate.
The Company intends to provide a full update once it completes
its ongoing research and analysis of the FM57 data.
The Company has filed a new patent application which has the
potential, if successful, to extend protection until 2040 as well
as appointed patent advisors to explore additional Intellectual
Property opportunities.
James Barder, Chief Executive Officer, Futura Medical said: "We
are encouraged by our initial interactions with the regulators
which endorse our early advice and belief that MED3000 will be
approved as a medical device with strong clinically proven claims
and remain confident that we will be in a position to file in
mid-2020 in the EU.
"MED3000 has proven to be a highly effective, safe and
differentiated therapy for ED, and FM57 data showed meaningful
clinical differences across all ED patient groups, mild, moderate
and severe as well as in a pooled analysis across all severities
for ED patients - a key evaluation criteria for regulators. Review
of all of the study data has been extensive and is continuing and
means that the Board now has a better understanding of the
mechanism of action. We are conducting additional clinical and
literature based research to further support this belief.
"We look forward to providing the market with further updates
with regards to timings for filing in the USA following our
pre-submission meeting with the US FDA, due to take place in Q1
2020."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
-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/ Hollie Vile
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 950 9144
Source
1. Araujo AC et al: The Management of Erectile Dysfunction with
Placebo Only: Does it work J Sex Med 6:3440-3448; 2009
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END
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