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GW Pharmaceuticals PLC
20 July 2007
Regulatory Update
Porton Down, UK, 20 July 2007: GW Pharmaceuticals plc (AIM: GWP) announces that
it has chosen to withdraw its current regulatory application for Sativex in
Europe and that it expects to resubmit an application for approval in 2008. This
follows constructive and detailed discussions with regulatory authorities in
which they have provided a clear path to approval for Sativex in the treatment
of MS Spasticity.
MS Spasticity Application
In September 2006, GW filed an application for Sativex under the decentralised
procedure in four European countries (UK, Spain, Denmark, Netherlands) for the
relief of MS Spasticity. GW has been able to resolve successfully all the major
questions raised by the regulators during this process except one, and at a
meeting with the UK assessors this week, it became clear that this outstanding
issue requires the generation of additional data. As European regulatory rules
do not permit the introduction of new data as part of the current process, GW
has elected to withdraw and resubmit its application.
The current regulatory application process has confirmed that quality and safety
data are already sufficient to support a marketing authorisation of Sativex. The
regulators have also confirmed that existing efficacy data provide statistically
significant evidence and 'could in principle lead to a positive risk benefit
conclusion'. In addition, regulators have recognised that a large proportion of
otherwise treatment-resistant patients respond to Sativex by obtaining
clinically meaningful improvements in spasticity.
Sativex provides benefit to the most high need MS patients who have no further
therapeutic options available. The regulator's outstanding clarification relates
to the fact that in a clinical trial context, the benefit obtained by '
responders' can be masked by looking at the mean improvement across the whole
studied patient population, which comprises both responders and non-responders.
The regulators therefore wish to be able to identify Sativex responders in the
first 4 weeks of treatment and to confirm that the improvements gained by such
responders over a further 12 week period is significantly greater than placebo.
As part of the current regulatory process, GW performed analyses of existing
data showing that responders can be reliably identified after 4 weeks and that,
after 12 weeks, the difference from placebo is clinically important and highly
statistically significant (p=0.015). The regulators view this as acceptable
evidence of efficacy in principle but consider these analyses technically to be
'post-hoc' since they were performed at the regulator's request following
completion of the trials. They require such data to be produced as part of a
prospectively planned analysis and hence GW will undertake an additional study
to re-confirm this result prior to resubmitting its regulatory application.
The regulators have given GW clear guidance as to the design of the further
study required, which differs from a conventional Phase III design. The study is
expected to start recruiting patients in the next few months, with the results
due in the second half of 2008. The regulators have specified a novel 'enriched
design' which first identifies responders over a 4 week period, and then focuses
on analysing the effect of Sativex vs placebo on those responders over a further
period of time.
GW's clinical plans for the next twelve months have for some time included a
further MS Spasticity trial and the regulator's specific design requirements
will therefore be incorporated into the planned study. This study is already
within GW's budget for 2008, will not result in any increase in rate of R&D
expenditure above current levels and will be financed from existing cash
resources, which today stand at £19.5m.
Sativex Resubmission
There are two potential opportunities for early re-submission in Europe next
year. In the indication of MS Neuropathic Pain, a second pivotal Phase III trial
completes in early 2008 which could lead to a regulatory filing in this
indication at that time. Since this is a distinct indication from MS Spasticity,
the outstanding issue identified as part of this recent application would not be
relevant. In the event that GW does not submit for this indication, the second
opportunity is to resubmit for MS Spasticity later in 2008 following completion
of the new study outlined above.
Dr Stephen Wright, R&D Director, said, 'We are encouraged that the regulators
see Sativex as providing useful efficacy and that they accept our quality and
safety data as sufficient for approval. This regulatory application has provided
us with a clear route to approval for Sativex in the relief of MS Spasticity. We
have received detailed and constructive guidance from the regulators on how to
satisfy their single outstanding requirement and are confident that we can
address this.
'We expect to re-submit our application to the regulators in Europe in 2008,
either in the indication of MS Neuropathic Pain or MS Spasticity. Elsewhere, we
look forward to receiving final regulatory approval in Canada for the Cancer
Pain indication in the coming weeks and our first large scale clinical trials in
the US are scheduled to commence in the late summer.'
Professor Mike Barnes, President of the World Federation of
Neuro-rehabilitation, Professor of Neurological Rehabilitation and Consultant
Neurologist, University of Newcastle, said, 'The data clearly show that Sativex
provides valuable and much needed relief of MS Spasticity. Indeed, this medicine
is able to treat some of the highest need MS patients, who currently have no
further treatment options available. It is regrettable and unnecessary in my
view, and in the view of other prominent members of the MS treatment community,
that the regulators require GW to generate further data to show what we already
know - that Sativex is a safe and efficacious treatment for people with MS.'
Dr Geoffrey Guy, GW Chairman, said, 'We recognise that it is taking longer than
we had hoped for Sativex to obtain approval in Europe. Each step, however, has
been one of progress towards achieving this goal. Whilst we complete these final
steps, we will continue to respond to the needs of people with MS by ensuring
Sativex remains available under our named patient prescription programme.'
There will be a conference call for analysts today at 8.30am BST. Analysts
should contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113
for details. There will be a live audio web cast of this call, which will be
accessible on the press releases page in the investor relations section of the
GW website (www.gwpharm.com). A recording of this call will be available on the
GW website later today.
Enquiries:
GW Pharmaceuticals plc Today: +44 20 7831 3113
Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000
Justin Gover, Managing Director
Mark Rogerson, Press and PR Tel: + 44 7885 638810
Financial Dynamics Tel: +44 20 7831 3113
David Yates, Ben Atwell
About Sativex
Sativex is being developed for approval in four target indications (MS
Spasticity, MS Neuropathic Pain, Cancer Pain and Peripheral Neuropathic Pain).
Each of these indications provides a distinct regulatory opportunity and is
supported by a specific clinical development programme.
In Canada, Sativex is approved for the relief of MS Neuropathic Pain and has
also received a Qualifying Notice from the Canadian regulators for a further
approval in the relief of Cancer Pain. Final approval of the Cancer Pain
indication is expected shortly.
In the United States, the lead indication for Sativex is Cancer Pain and,
following a series of positive meetings with the Food & Drug Administration
(FDA), late stage trials in that country are about to commence.
GW has to date entered into three Sativex license agreements - with Otsuka in
the US, with Bayer HealthCare in the UK and Canada, and with Almirall in Europe
(ex-UK). These agreements together have yielded financial terms to GW totaling
$51m of signature fees, up to $376m of milestone payments as well as significant
long term supply price provisions.
About GW
GW was founded in 1998 and listed on the AiM, a market of the London Stock
Exchange, in June 2001. Operating under license from the UK Home Office, the
company researches and develops cannabinoid pharmaceutical products that
alleviate pain and other neurological symptoms in patients who suffer from
serious ailments. GW has assembled a team of over 100 scientists with extensive
experience in developing both plant-based prescription pharmaceutical products
and medicines containing controlled substances. GW occupies a world leading
position in cannabinoids and has developed an extensive international network of
the most prominent scientists in the field. For further information, please
visit
www.gwpharm.com
This news release may contain forward-looking statements that reflect GWs
current expectations regarding future events, including development and
regulatory clearance of the GW's products. Forward-looking statements involve
risks and uncertainties. Actual events could differ materially from those
projected herein and depend on a number of factors, including (inter alia), the
success of the GW's research strategies, the applicability of the discoveries
made therein, the successful and timely completion of uncertainties related to
the regulatory process, and the acceptance of Sativex and other products by
consumer and medical professionals.
This information is provided by RNS
The company news service from the London Stock Exchange
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2006 MoneyAM© |
