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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| GW Pharm. | LSE:GWP | London | Ordinary Share | GB0030544687 | ORD 0.1P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 735.00 | 0.00 | 01:00:00 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| 0 | 0 | N/A | 0 |
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RNS Number:1687X
GW Pharmaceuticals PLC
13 June 2002
Embargoed until 0700 13 June 2002
GW Pharmaceuticals plc
("GW" or "the Company")
Interim Results For The Six Months To 31 March 2002
Highlights
• Phase III trials programme for cannabis-based medicines remains on track
- Two new Phase III trials targeting specific symptoms of Multiple
Sclerosis announced today
- Total of nine Phase III trials now underway, including Multiple
Sclerosis, Spinal Cord Injury, Neuropathic Pain, Cancer Pain
• Recruitment in the leading four Phase III trials now over 85% complete and
on schedule
• Ongoing positive results from Phase II trials
• Establishment of Cannabinoid Research Institute and appointment of
Professor Roger Pertwee, one of the world's leading cannabinoid scientists,
as Director of Pharmacology
• Arrangements for commercial scale cultivation, extraction and final
product manufacture in place in preparation for market launch
• New Home Office-backed collaboration with National Addiction Centre for
use of GW's secure drug dispensing technology in prescribing of methadone
and diamorphine (being announced separately today)
• Net loss for the six months to 31 March 2002 of £5.3m, in line with budget
• Cash reserves at 31 March 2002 of £21.1m
Dr Geoffrey Guy, Executive Chairman of GW Pharmaceuticals, said: "Progress
across the breadth of the Group's activities has continued according to
expectation in the first half of the financial year and GW's development
programme remains firmly on track. Looking ahead, the first Phase III clinical
trials should report results towards the end of this year and, if successful,
the results of these trials will form the basis of our first product submission
to the Medicines Control Agency. With arrangements in place with respect to
commercial scale cultivation, extraction and manufacturing, GW is on track to be
market-ready well ahead of our planned market launch in early 2004.
"In addition, the new product development programmes for the treatment of heroin
addiction being announced separately today provide a significant exciting new
market opportunity for the Group."
A presentation for analysts is taking place today at 09.00 at Weber Shandwick
Square Mile, Aldermary House, 15 Queen Street, London EC4. An audio webcast of
the presentation will be available on GW's website at www.gwpharm.com from 15.00
today.
Enquiries:
GW Pharmaceuticals plc (13/06/02) 020 7950 2800
Dr Geoffrey Guy, Chairman (Thereafter) 01980 557000
Justin Gover, Managing Director
Weber Shandwick Square Mile 020 7950 2800
Kevin Smith/Graham Herring
GW Pharmaceuticals plc
("GW" or "the Company")
Interim Results For The Six Months To 31 March 2002
HALF YEAR REVIEW
GW continued to make good progress with its development programme in the first
six months of the financial year. The Company's clinical trials programme
remains on track and investment and expenditure remain in line with forecasts.
Phase III Update
Since the beginning of this financial year, GW has commenced eight Phase III
clinical trials to support our first regulatory applications. The start of the
latest two of these trials is being announced today. These new trials target
specific symptoms of Multiple Sclerosis - spasticity and bladder dysfunction.
Including the first Multiple Sclerosis trial which commenced in May 2001, GW now
has nine Phase III trials underway. These trials will involve approximately 650
patients.
The trials are progressing to schedule with recruitment in the leading four
Phase III trials now over 85% complete.
GW now has in place a broad Phase III trials programme simultaneously examining
a range of different symptoms and medical conditions. This programme is
designed to generate safety and efficacy data to allow GW to seek regulatory
approval for its cannabis-based medicines in a range of medical conditions.
Results from the first few trials to complete are intended to form the basis of
GW's first regulatory submission to the Medicines Control Agency, scheduled for
2003. Target timescales for our lead products, as stated at the time of the
Company's flotation on the Alternative Investment Market (AiM) in mid 2001,
remain on track.
The Phase III trials programme is examining the effectiveness of cannabis-based
medicines in the following medical conditions:
• Multiple Sclerosis (multiple symptoms)
• Cancer Pain
• Brachial plexus injury (a severe form of nerve-damage pain)
• Pain in Spinal Cord Injury
• Pain & Sleep in Multiple Sclerosis and Spinal Cord Injury
• Neuropathic pain in Multiple Sclerosis
• General neuropathic pain (as evidenced by allodynia - a painful response
to typically non-painful stimulus)
All trials are double-blind and placebo controlled, and are taking place at
hospital centres around the UK. Certain trials also include centres in other
European countries. The cannabis-based medicine is being administered by means
of an oro-mucosal spray.
Phase II Update
GW's Phase II trials have involved approximately 120 patients to date. Of the
first 109 patients, 88 completed the acute phase, of which 86 elected to
continue long term.
In January 2002, GW presented an updated set of data from Dr Notcutt's Phase II
trial in Multiple Sclerosis and Spinal Cord Injury patients. This data showed
statistically significant improvement in chronic pain even in small patient
numbers. Also in January, GW presented data from a Phase II trial examining the
effects of cannabis-based medicines on bladder function in MS patients. Initial
positive results from this study have been presented by the trial investigators
at scientific symposia. The results demonstrated the potential for cannabis
medicines to produce significant improvements in a range of lower urinary tract
symptoms including incontinence in MS patients. This result is not only
applicable for MS but indicates potential in the wider incontinence market, a
very substantial market in its own right.
New previously unreleased data from Dr Robson's and Professor Wade's Phase II
trial in 24 Multiple Sclerosis patients is currently being prepared for
publication. Key findings from this study are that improvements have been seen
across a range of MS symptoms, several of which have reached statistical
significance despite the small patient numbers. Perhaps most importantly, data
from this study have revealed the potentially exciting properties of GW's plant
extract containing principally the non-psychoactive cannabinoid, cannabidiol ("
CBD"). The CBD extract product outperformed other products in relieving pain
and GW is now examining the potential incorporation of CBD into larger MS
trials.
Following data from early Phase II trials, which demonstrated an apparent
improvement in duration and quality of sleep, GW commissioned a specific Phase
II study at a sleep laboratory in eight subjects to investigate this matter
further. Encouragingly, the study showed that cannabis-based medicine produced
no pathological effects on the process of normal sleep. The results suggest
that rebound insomnia, a common problem with hypnotic drugs such as
benzodiazepines, would not be expected to occur to any significant degree
following cessation of long-term treatment with cannabis-based medicine.
Interestingly, CBD and tetrahydrocannabinol ("THC") had rather different effects
on the central nervous system, and this interaction resulted in some useful
consequences, in particular it was shown that CBD modulated certain effects of
THC.
Positive results have also been presented from an exploratory post-operative
pain study in patients post hysterectomy. Pain relief in the immediate
post-operative period may provide an additional potential market for GW's
products not previously identified in the company's prospectus. A pilot study
is due to commence shortly, which may be followed by a larger Phase III study.
Importantly, the Phase II data generated to date continues to provide confidence
in the Phase III programme being undertaken and indeed has revealed additional
unexpected findings which may yield potential new product and market
opportunities.
Regulatory Affairs
During the period, GW received its first regulatory approval from the Irish
Medicines Board to carry out clinical trials in Ireland. Permissions have also
been received to carry out clinical trials in Belgium. Meetings with regulatory
authorities around Europe continue and are proving helpful in allowing us to
form a strategy to secure regulatory approval throughout Europe following the
first UK approval.
Cannabinoid Research Institute
In March, GW announced that Professor Roger Pertwee, Professor of
Neuropharmacology at the University of Aberdeen, has joined GW's senior
management team as Director of Pharmacology. Professor Pertwee is one of the
world's leading cannabinoid scientists, having researched this area for over 30
years, and is the author of over 220 publications. In his role at GW, Professor
Pertwee will focus on pharmacology in support of the Group's clinical trials
programmes and novel research, including the investigation of new therapeutic
areas.
The appointment marks the first step in the planned establishment by GW of a new
research entity - the Cannabinoid Research Institute. The Institute will be a
distinct division within the Company and its activities will be directed by Dr
Philip Robson, GW's Medical Director. The Institute will allow GW to expand its
operations from clinical and pre-clinical work into fundamental cannabinoid
research.
It is our aim that GW should occupy the centre ground of cannabinoid science.
By establishing the Cannabinoid Research Institute, we are building a bridge
between commercial enterprise and academia. We are confident that this is the
best way for GW to undertake fundamental science, and to investigate the future
commercial opportunities which may arise with phytocannabinoids, which occur in
plants, as well as synthetic cannabinoids and also endocannabinoids, which occur
naturally within the human body.
We hope over time to involve other collaborators, so that scientists from inside
and outside GW can conduct research into the mammalian cannabinoid system and
potential therapeutic candidates for cannabis-based medicines.
Operations
Activity in the first half of the financial year has been concentrated on
preparing GW's cultivation and production capabilities for market launch. All
key arrangements relating to commercial scale production are now in place.
An additional indoor cultivation facility has now been completed and is
operational. This facility has doubled our growing capacity to over 30 tonnes
of plant material per year. We have entered into arrangements with a third
party contractor to cater for a significant further step-up of growing capacity
(doubling current capacity to 60 tonnes of plant material) to cater for product
launch. This arrangement also covers expansion to cater for potential future
cultivation requirements for worldwide product sales.
GW's extraction facility has been upgraded to meet appropriate standards of Good
Manufacturing Practice ("GMP") ahead of product launch. This facility can cater
for significant commercial sales of product. Arrangements are also in place
with a contract manufacturing partner with regard to establishing commercial
scale GMP final product manufacturing facilities. This will meet production
needs for significant commercial quantities of product.
Public Affairs
We were pleased to welcome the announcement by the UK Department of Health that
it has recommended that GW's cannabis-based medicines be included in the list of
drugs to be reviewed by the National Institute for Clinical Excellence ("NICE")
in 2003 ahead of possible provision of the Group's medicines by the National
Health Service. Recommendation by NICE would further smooth the way for
cannabis-based medicines to be available nationwide to NHS patients on
prescription, assuming our current trials are successful.
Advanced Dispensing System
The Advanced Dispensing System ("ADS") technology has been under development by
GW for a number of years for use with its cannabis-based medicines. This
proprietary technology is wholly owned by GW. GW has recognised the broad
commercial potential of this technology and has developed it so that it can be
applied to a wide range of drugs in a range of dosage forms.
ADS comprises a hand-held intelligent device which can dispense a range of drugs
and dosage forms housed in a proprietary medicinal cartridge format. The
devices can communicate in real time through proprietary software systems to
back-end users through existing telecommunication technologies.
ADS provides pharmaceutical companies, doctors, clinicians and others the
ability to monitor and, if required, control drug usage in real time. The
technology also provides a secure and tamper-proof means of dispensing
controlled drugs. ADS has the potential, therefore to enhance a drug's safety,
prevent diversion, provide greatly increased flexibility in prescribing
patterns, permit the monitoring of a patient's progress remotely and the
adaptation of prescribing regimes on a day by day basis as required, and provide
information on natural patterns of consumption of prescribed drugs in the
community.
Methadone/Diamorphine Programme
GW is today announcing a major new Home Office-backed initiative in
collaboration with Professor John Strang, Director of the National Addiction
Centre and senior drugs adviser to the UK Government. This initiative aims to
provide a significant advance in the treatment of drug dependency using GW's ADS
technology. The initiative will run in parallel with GW's core cannabis-based
pharmaceutical development programme.
It is recognised by the UK Government that treatment of drug addiction has a
major impact on crime reduction and a key policy objective at present is to
increase the participation of problem drug misusers in drug treatment
programmes. Treatment focuses on the use of methadone and diamorphine but there
remains grave concern at the potential for abuse of these controlled drugs. The
Home Office has recognised that GW's ADS system could make a significant
contribution both in reduction of diversion and improvement in general treatment
compliance. The Home Office has therefore provided its endorsement and support
for this programme.
The programme provides GW with at least two new product opportunities. The near
term opportunity relates to new improved methadone dosage forms incorporated
into the ADS system. Trials in this area are expected to commence in the coming
few months and could, if successful, lead to rapid roll-out of GW's product into
addiction centres across the UK. The diamorphine opportunity is longer term.
The potential market for GW is considerable. There are an estimated
200,000-250,000 heroin addicts in the UK alone, of which just 30,000 now use
methadone treatment. The scale of the problem is similar across all European
countries. The Home Office has stated that it believes ADS would allow for much
larger numbers of addicts to receive effective treatment. Current government
funding on treatment services for drug misusers in the UK is approximately £230m
and is expected to rise to about £400m next year under existing expansion plans.
In addition, since the drugs being incorporated into the ADS technology are
already approved drugs, there is a greater probability of success than with
conventional drug development programmes.
Financial Review
In the six months to 31 March 2002 GW made a net loss after tax of £5.3m
compared to £4.8m in the second half of the last financial year and £2.0m in the
comparable period last year. The increase over the prior periods is due to the
planned increase in all the Company's activities and was in line with our
budget.
Research and development expenditure increased to £5.1m (2001: H2 £4.7m; H1
£2.0m). This increase reflects the rapid advancement of our clinical trials
programme and the necessary associated activities.
Management and administrative expenses (including amortisation of goodwill)
increased to £1.1m (2001: H2 £0.8m; H1 £0.3m). The rate of increase in these
costs has slowed significantly reflecting the fact that the majority of the
required infrastructure was put in place during the latter part of last
financial year.
Operating losses of £6.2m (2001: H2 £5.4m; H1 £2.3m) were reduced by interest
income of £0.47m (2001: H2 £0.40m; H1 £0.11m), due to the significant increase
in funds following the IPO last summer, and an R&D tax credit of £0.43m (2001:
H2 £0.20m; H1 £0.15m).
Net cash outflow before management of liquid resources and financing was £4.5m
(2001: H2 £4.1m; H1 £2.5m). At 31 March 2002 GW had cash and short term
deposits totalling £21.1m.
Capital expenditure incurred in the period was £0.42m (2001: H2 £0.43m; H1
£0.44m) comprising largely the continuing investment in our cultivation,
production and manufacturing facilities.
Headcount as at 31 March 2002 was 102 compared to 85 at 30 September 2001.
Prospects
The second half of this year represents a very exciting time for GW. The
furthest advanced of our Phase III trials will near completion and, shortly
thereafter, we hope to submit our first product licence application to the
Medicines Control Agency in early 2003 as planned. We also look forward to
further expanding our cannabinoid interests. In addition, we expect the
development of our new products for the treatment of drug dependency to make
good progress.
- Ends -
Enquiries:
GW Pharmaceuticals plc (13/06/02) 020 7950 2800
Dr Geoffrey Guy, Chairman (Thereafter) 01980 557000
Justin Gover, Managing Director
Weber Shandwick Square Mile 020 7950 2800
Kevin Smith/Graham Herring
Consolidated profit and loss account
for the six months ended 31 March 2002
Six months ended Six months ended Year ended
31 March 31 March 30 September
Notes 2002 2001 2001
Unaudited Unaudited Audited
£000's £000's £000's
Turnover - - -
Research and development costs (5,051) (1,990) (6,642)
Management and administrative expenses (1,144) (312) (1,083)
-------------- -------------- --------------
Operating loss (6,195) (2,302) (7,725)
-------------- -------------- --------------
Continuing operations (6,195) (2,302) (7,576)
Acquisitions - - (149)
-------------- -------------- --------------
(6,195) (2,302) (7,725)
Interest receivable 470 110 514
Interest payable (1) (1) (1)
-------------- -------------- --------------
Loss on ordinary activities before taxation (5,726) (2,193) (7,212)
Tax credit on loss on ordinary activities 435 148 347
-------------- -------------- --------------
Loss on ordinary activities after taxation being
retained loss for the period (5,291) (2,045) (6,865)
-------------- -------------- --------------
Loss per share - basic and diluted 3 (5.5p) (3.1p) (9.0p)
All activities relate to continuing operations.
The Group has no recognised gains and losses other than the losses above and
therefore no separate statement of total recognised gains and losses has been
presented.
Consolidated balance sheet
as at 31 March 2002
31 March 31 March 30 September
Notes 2002 2001 2001
Unaudited Unaudited Audited
£000's £000's £000's
Fixed assets
Intangible assets - goodwill 6,815 - 6,992
Tangible assets 974 474 740
-------------- -------------- --------------
7,789 474 7,732
-------------- -------------- --------------
Current assets
Debtors: amounts due after more than one year 2 435 - -
Debtors: amounts falling due within one year 784 644 976
Cash at bank and in hand 21,123 6,282 25,650
-------------- -------------- --------------
22,342 6,926 26,626
Creditors: Amounts falling due within one year (2,718) (662) (1,762)
-------------- -------------- --------------
Net current assets 19,624 6,264 24,864
Total assets less current liabilities 27,413 6,738 32,596
Creditors: Amounts falling due after more than one year (18) (2) -
Provisions for liabilities and charges (110) (7) (20)
-------------- -------------- --------------
Net assets 27,285 6,729 32,576
-------------- -------------- --------------
Capital and reserves
Called-up share capital 96 2 96
Share premium account 23,491 - 23,491
Other reserves 19,262 12,181 19,262
Profit and loss account (15,564) (5,454) (10,273)
-------------- -------------- --------------
Equity shareholders' funds 27,285 6,729 32,576
-------------- -------------- --------------
Consolidated cash flow statement
For the six months ended 31 March 2002
Six months ended Six months ended Year ended
31 March 31 March 30 September
2002 2001 2001
Unaudited Unaudited Audited
£000's £000's £000's
Net cash outflow from operating activities (4,577) (2,133) (6,317)
Returns on investment and servicing of finance 447 110 470
Taxation - - 93
Capital expenditure (419) (442) (876)
Acquisitions and disposals - - 30
-------------- -------------- --------------
Cash outflow before management of liquid
resources and financing (4,549) (2,465) (6,600)
Management of liquid resources 3,726 (4,120) (22,700)
Financing 22 7,018 30,521
-------------- -------------- --------------
(Decrease) / increase in cash during the period (801) 433 1,221
-------------- -------------- --------------
Reconciliation of operating loss to net cash outflow from operating activities
Six months ended Six months ended Year ended
31 March 31 March 30 September
2002 2001 2001
Unaudited Unaudited Audited
£000's £000's £000's
Operating loss (6,195) (2,302) (7,725)
Depreciation charge 179 75 259
Loss on sale of tangible fixed assets 6 - -
Amortisation of goodwill 177 - 140
Decrease / (increase) in debtors 192 (310) (483)
Increase in creditors 1,064 404 1,492
-------------- -------------- --------------
Net cash outflow from operating activities (4,577) (2,133) (6,317)
-------------- -------------- --------------
1 Basis of preparation
These accounts are unaudited and do not constitute statutory accounts within the
meaning of section 240 of the Companies Act 1985. The interim results have been
prepared on the basis of the accounting policies set out in the Report and
Accounts for the year ended 30 September 2001, with the exception that FRS19
Deferred Tax has been adopted from the beginning of the period. The effect of
adopting FRS19 is not material to the Group. The financial information relating
to the year ended 30 September 2001 has been extracted from the full report and
accounts which have been delivered to the Registrar of Companies. The report of
the auditors on those accounts was unqualified.
2 Tax on loss on ordinary activities
The tax credit in the period of £435,000 has arisen as a result of the research
and development expenditure claimed under the Finance Act 2000 and is subject to
the agreement of the Inland Revenue. The amount is shown as a debtor due after
more than one year.
3 Loss per share
The calculations of loss per share are based on the following losses and numbers
of shares.
Six months ended Six months ended Year ended
31 March 31 March 30 September
2002 2001 2001
£000's £000's £000's
Loss for the financial period 5,291 2,045 6,865
-------------------- -------------------- --------------------
Number of shares Number of shares Number of shares
Weighted average number of shares 96,027,099 65,340,364 75,949,639
-------------------- -------------------- --------------------
The weighted average number of shares for the 6 month period to 31 March 2001
has been adjusted for the bonus issue on 3 April 2001 where an additional 28
bonus shares were issued for every existing share.
Since the Group reported a net loss, diluted loss per share is equal to basic
loss per share.
4 Analysis of changes in net funds
As at Cashflow As at
30 September 2001 31 March 2002
Audited Unaudited Unaudited
£000's £000's £000's
Cash at bank and in hand 1,650 (801) 849
Finance leases (4) (22) (26)
Liquid resources 24,000 (3,726) 20,274
-------------- -------------- --------------
Total 25,646 (4,549) 21,097
-------------- -------------- --------------
This information is provided by RNS
The company news service from the London Stock Exchange
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