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Futura Medical PLC
09 November 2018
Futura Medical Presents Data on MED2005 for the Treatment of
Erectile Dysfunction at the 19th Annual Fall Scientific Meeting of
Sexual Medicine Society of North America (SMSNA)
9 November 2018
Futura Medical plc (AIM: FUM) (the "Company"), a pharmaceutical
company developing a portfolio of innovative products for sexual
health and pain relief, today announces that it will be presenting
data on its DermaSys(R) drug delivery technology and lead product
MED2005(1) , a topical glyceryl trinitrate ("GTN") gel for the
treatment of erectile dysfunction ("ED"), at the 19(th) Annual Fall
Scientific Meeting of SMSNA, on 8-11 November 2018 at the Loews
Miami Beach Hotel, Miami, Florida USA.
Tim Holland, Director of Clinical Development at Futura Medical,
will give an oral presentation (#155) entitled "Pharmacokinetics
(PK) of MED2005, a Topical Glyceryl Trinitrate Gel for the
Treatment of Erectile Dysfunction(2) " on Friday 9 November at
16:25 EST. The presentation will be part of the 'Erectile
Dysfunction (Medical) - Moderated Posters' session.
The PK data to be presented demonstrate that MED2005 has been
shown to have a rapid absorption, good bioavailability and an
acceptable safety profile at doses higher than 0.2% studied in the
previously reported Phase 2 clinical study ("FM53"). In addition,
the PK study demonstrated similar or lower bioavailability of GTN
when administered via MED2005 compared with Nitrostat(R) at doses
0.2%, 0.4%, and 0.6% GTN.
Results also demonstrated that plasma concentrations of GTN and
its two major metabolites increased proportionally with increasing
MED2005 dosage. The highly encouraging results build on the data
from FM53 that demonstrated statistically significant benefit over
placebo in humans using the internationally accepted IIEF-EF trial
endpoints. This supports the Company's strong belief that the
higher dose forms of MED2005 should improve efficacy with an
acceptable safety profile and meet US FDA's requirements for the
simplified 505(b)2 regulatory pathway. Results of FM53 were
published in a peer reviewed paper in The Journal of Sexual
Medicine in February 2018.
James Barder, Chief Executive Officer of Futura Medical, said:
"We are very pleased to share in more detail these meaningful
findings on our lead programme MED2005 with the medical community
at this prestigious meeting. These PK data demonstrate the
potential of MED2005 as a safe and fast-acting erectile dysfunction
treatment with a favourable side effect profile, a key
differentiator to other ED products on the market."
Futura recently announced that the first patient has been
enrolled in the first European Phase 3 study, ("FM57"), of MED2005
that will recruit approximately 1,000 patients with mild, moderate
or severe ED
ENDS
(1) Holland, T(1) ; Mason, R(2) ; Terrill, P(3) ; Blakey, G(4) ;
James, K(1)
1: Futura Medical Developments Limited; 2: RSM Medical Services
Limited; 3: Cytel UK; 4: Consult2deliver
The study was funded by Futura Medical.
(2) MED2005 is the codename used by Futura for the 'locked'
formulation for use in ongoing clinical trials. MED2002 is the
codename used by Futura for all proprietary formulations of
GTN.
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
Nominated Adviser and Broker:
N+1 Singer
Aubrey Powell/ Ben Farrow (Corporate Finance)
Tom Salvesen/ Mia Gardner (Corporate Broking)
Tel: +44 (0) 20 7496 3000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Hollie Vile/ Ellie Blackwell
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 20 3950 9144
Notes to editors:
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) drug delivery technology.
These products are optimised for clinical efficacy, safety,
administration and patient convenience and 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.
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange.
www.futuramedical.com
About MED2005: Eroxon(R) - Topical treatment for erectile
dysfunction (ED)
MED2005, which uses Futura's DermaSys(R) drug delivery system,
is the development name for its topical glyceryl trinitrate ("GTN")
gel. It has the potential to be a highly differentiated therapy for
the treatment of men with ED, especially mild to moderate ED.
MED2005's rapid onset of action means that it has the potential to
become the world's fastest-acting treatment for ED, with a speed of
onset of around five minutes. Viagra(R) and Cialis(R) which
dominate the existing on-market ED therapies are taken orally and
do not take effect for at least 30 minutes and typically one hour
or more(1) . Speed of onset and method of administration of MED2005
also help restore spontaneity and intimacy. Importantly, MED2005
may also be appropriate for ED sufferers on nitrates and other
drugs that are contraindicated for 5 use with
phosphodiesterase-5-inhibitors ("PDE5Is") such as Viagra(R) and
Cialis(R) and other existing oral ED treatments.
Note 1: US patient information for Viagra(R) and Cialis(R)
Forward looking statements
This announcement may contain certain forward-looking
statements. Whilst the Directors believe all such statements to
have been fairly made on reasonable assumptions, there can be no
guarantee that any of them are accurate or that all relevant
considerations have been included in the directors' assumptions;
accordingly, no reliance whatsoever should be placed upon the
accuracy of such statements, all of which are for illustrative
purposes only, are based solely upon historic financial and other
trends and information, including third party estimates, and may be
subject to further verification. These forward-looking statements
are based on management's current expectations as of the date of
this announcement and should not be relied upon as representing the
Company's views as of any date subsequent to the date of this press
release. These statements involve known and unknown risks,
uncertainties and other important factors that may cause the
Company's actual results, performance or achievements to be
materially different from any expectations expressed or implied by
the forward-looking statements. These and other important factors,
under the heading "Risk Factors" in the Company's recently issued
circular to shareholders in relation to its proposed fundraising
(available at
https://www.futuramedical.com/archive/2018-GM-Notice-121118.pdf)
and under the heading "Principal risks and uncertainties" in the
Company's last annual report, could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this announcement. Neither the Company nor its Directors
makes any representation or warranty in respect of the accuracy,
completeness or verification of the contents of this
announcement.
James Barder, CEO, and Angela Hildreth, FD & COO arranged
for the release of this announcement on behalf of the Company.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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November 09, 2018 02:00 ET (07:00 GMT)
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