TIDMFUM
RNS Number : 0797D
Futura Medical PLC
24 June 2019
AGM Statement
-- Patient recruitment completed for MED2005 first European
Phase 3 study "FM57" and on track to deliver headline data by the
end of 2019
-- TPR100 - Thornton & Ross responding to MHRA questions
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 currently focused on sexual health and pain, is
pleased to announce that John Clarke, Chairman, will provide the
following update at the Company's Annual General Meeting ("AGM")
which is being held at 10am BST later today in London.
MED2005 -Topical gel for erectile dysfunction ("ED")
On 19 June 2019, the Company announced the completion of patient
recruitment for the first European Phase 3 study, "FM57", of
MED2005. The 1,000 patient study for the treatment of mild,
moderate and severe erectile dysfunction ("ED") includes
approximately 60 centres across Central and Eastern Europe. Futura
remains on track to deliver headline data by the end of 2019.
Planning for a second, confirmatory Phase 3 study for MED2005
has been undertaken, after extensive dialogue with regulators and
KOLs in the field of ED. This study will incorporate a US patient
cohort which is expected to facilitate regulatory filing in the US.
This second study will be informed by the receipt and analysis of
the first Phase 3 data. The Company plans to shortly commence
pre-recruitment start-up activities, such as Regulatory and Ethics
approvals which can take up to six months to complete to ensure
recruitment is not delayed. Patient recruitment will start as soon
as possible after the first Phase 3 study data analysis is
complete.
It is usual for two Phase 3 studies to be required for
regulatory filing. However, depending on data from the first
European Phase 3 study, Futura may explore filing MED2005 with
regulatory bodies in Europe with one Phase 3 study which could
occur during 2020. The US FDA has been clear that two studies are
required, and filing will await results from the second Phase 3
study.
TPR100 - Topical gel for pain relief
The Company's novel topical pain relief gel TPR100 is partnered
for manufacturing and distribution in the UK with Thornton &
Ross, one of the UK's largest consumer healthcare companies and a
subsidiary of STADA AG. In response to Thornton & Ross's
marketing authorisation application filed in July 2018, the UK
Medicines and Healthcare products Regulatory Agency (MHRA) has
raised a number of questions requiring additional lab work to be
conducted. This work is well advanced, and we expect Thornton &
Ross to respond to the MHRA in September with regulatory opinion
before the end of the year.
The Company has received expressions of interest from a number
of parties to enable Futura to expand the geographical reach of
TPR100. Futura is awaiting regulatory authorisation in the UK
before progressing further.
Futura's Chairman, John Clarke, commented: "We continue to make
good progress in the development and commercialisation of our
pipeline of product opportunities. We are pleased to have completed
recruitment for the first European Phase 3 study of MED2005 and
eagerly await the Phase 3 data read-out at the end of the year. We
look forward to updating the market on Futura's developments during
2019, which I expect to be a year of very significant progress for
the Company."
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 Sole Broker:
Liberum
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 203 100 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
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.
The first European Phase 3 study for MED2005, referred to as
"FM57", is a 1,000 patient, dose-ranging, multi-centre, randomised,
double blind, placebo-controlled, home use, parallel group study of
MED2005 0.2%, 0.4% and 0.6% Glyceryl Trinitrate for the treatment
of erectile dysfunction with an open label extension. FM57 is
progressing on track, with headline data expected by the end of
2019.
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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