Futura Medical PLC MED2002 Regulatory Update (6256G)
May 31 2017 - 1:00AM
UK Regulatory
TIDMFUM
RNS Number : 6256G
Futura Medical PLC
31 May 2017
For immediate release 31 May 2017
Futura Medical plc
("Futura" or the "Company")
MED2002 Regulatory Update
Futura Medical plc (AIM: FUM), the innovative healthcare company
focused on advanced transdermal technology, is pleased to provide
the following update on its discussions with US and UK regulatory
authorities on the clinical trial requirements and regulatory
pathway for MED2002, the Company's topical gel for erectile
dysfunction ("ED").
Summary and Highlights
-- Written responses received from regulators (the US FDA and
the UK MHRA) on regulatory pathway for MED2002
-- Responses support the Company's expectations, including on
timing for regulatory submissions for marketing authorisations,
anticipated in Q2 2019 following data from studies to be initiated
in Q4 2017
-- Recommendations to evaluate at higher doses to optimise
efficacy across the spectrum of all ED patients, as well as to
obtain limited additional safety data
The planned Phase III programme follows the successful clinical
results announced on 7 September 2016, confirming MED202 had met
its primary endpoint and showed efficacy, safety and speed of
onset. MED2002's rapid onset of action means that it has the
potential to be the world's fastest-acting treatment for ED.
James Barder, Futura's Chief Executive, commented: "We are
delighted by the constructive feedback provided on the remaining
development pathway for MED2002, our topical gel for ED, from both
the US and UK regulatory authorities. We believe that to have the
remaining development programme aligned with the authorities'
suggestions, and with no expected impact on overall timelines, this
is an excellent outcome and should provide reassurance for
shareholders and prospective licence partners alike. We look
forward to updating shareholders further on the development and
commercialisation of a product that has the potential to be the
world's fastest-acting treatment for ED."
Further details on the regulatory feedback and the Company's
development strategy for MED2002 are provided below:
Futura confirms that it has now received written responses
following constructive meetings with the US Food & Drug
Administration ("FDA") and the UK's Medicines and Healthcare
products Regulatory Agency ("MHRA"). There was a broad consensus
from both regulatory authorities on the development pathway for
MED2002 which validates the Company's previously disclosed target
of making regulatory submissions in US and certain EU territories
in H1 2019.
Both the FDA and MHRA confirmed filing routes by which the
Company can make use of the extensive pre-existing safety data on
the active ingredient in MED 2002, glyceryl trinitrate ("GTN"),
which has already been approved in other indications and is well
characterised. A limited amount of additional data will be required
to confirm that the unique application of the MED2002 gel to the
penis and the limited transference of the active ingredient to the
sexual partner do not present a safety issue. As anticipated,
MED2002's US filing will be via a 505(b)(2) investigational new
drug application and in Europe via an Article 8.3 of Directive
2001/83/EC (as amended).
The authorities gave their support in principle to the Company's
proposal to conduct a pivotal Phase III, placebo controlled,
parallel group, multi-centre clinical study. In addition, they
urged the Company to evaluate higher doses in addition to those
originally proposed of 0.2% and 0.4% to optimise efficacy across
the spectrum of all ED patients. The strategy of providing a range
of dose strengths is already followed by existing oral ED
treatments.
The Company intends to adopt this recommendation and will
conduct two Phase III studies, but with differing dosage protocols
to address the suggestions made by authorities whilst optimising
the chances of clinical success. The studies will also include a
cohort of ED patients taking other medication containing nitrates,
as these patients are currently contraindicated from taking
existing oral ED treatments.
The authorities also gave their support to Futura's proposal to
conduct a pharmacokinetic safety study to compare GTN blood plasma
levels of MED2002 with existing GTN drugs to support the proposed
abridged filings and confirm the expected low level of GTN
transference to the sexual partner. The latter was evidenced
through the extremely low side effect profile observed in women in
the Company's earlier study which concluded in 2016.
The timelines for the remaining study programme remain in line
with those outlined in the Company's preliminary results announced
on 23 March 2017, with the studies expected to begin with first
patient recruitment in Q4 2017 and regulatory submissions for
marketing authorisation expected to be made in Q2 2019. A further
regulatory meeting with the MEB, the Netherlands regulatory
authority, is also planned ahead of recruitment of the first
patient into the ongoing clinical trial programme.
For further information please contact:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0) 1483 685 670
Email to: james.barder@futuramedical.com www.futuramedical.com
N+1 Singer (Nominated Adviser
and Broker)
Aubrey Powell / Liz Yong Tel:+44 (0) 20 7496 3000
For media enquiries please contact:
Buchanan
Mark Court / Sophie Cowles / Tel: +44 (0) 20 7466 5000
Stephanie Watson
Notes to Editors
Futura Medical plc
Futura Medical is a pharmaceutical group that develops
innovative products for consumer healthcare. The Company is
developing a portfolio of products and its strategy is to license
their manufacture and distribution to major pharmaceutical and
healthcare groups. Futura is based in Guildford, Surrey, and its
shares trade on the AIM market of the London Stock Exchange.
www.futuramedical.com
This information is provided by RNS
The company news service from the London Stock Exchange
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