Aktuell am Boden...Langfristig Riesenchance - 500 Beiträge pro Seite
eröffnet am 14.06.05 14:25:53 von
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Beiträge: 59
ID: 987.313
ID: 987.313
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Gesamt: 4.747
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ISIN: GB0030544687 · WKN: 693692
8,2800
EUR
-4,22 %
-0,3650 EUR
Letzter Kurs 01.12.16 Lang & Schwarz
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 3,5800 | +922,86 | |
| 0,8800 | +95,56 | |
| 2.000,00 | +71,23 | |
| 384,00 | +20,00 | |
| 5,9050 | +17,86 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 4,3000 | -21,82 | |
| 14,510 | -32,32 | |
| 71,33 | -33,92 | |
| 3,6400 | -38,62 | |
| 0,7000 | -61,85 |
Feedback
Es geht um GW Pharmaceuticals (s. auch Thread: ENDLICH!!!! Jetzt geht es UP!!!!)
Letzte Woche kam die News raus, daß sich die Zulassung von Sativex in UK verzögern wird; hier die Kursreaktion:
Dabei ändert das nichts an den langfristigen Aussichten:
Abgesehen vom Marktpotential spricht folgendes für die Aktie:
1. Zulassung in Kanada ist erfolgt, bald stehen dort erste Einkünfte an
2. Potenter Partner (Bayer)
3. Im Gegensatz zu sonstigen Pharma"neuentwicklungen" ist das Risiko äußerst begrenzt, da Cannabis jahrtausedelang erprobt ist und alle (zahlreichen) Versuche, bedeutsame substanzspezifische negative Nebenwirkungen bei realistischer Dosierung nachzuweisen, gescheitert sind.
4. Der Markt ist heiß auf das Produkt
Mehr Infos: http://boards.fool.co.uk/Message.asp?mid=8841281&sort=recomm…
Letzte Woche kam die News raus, daß sich die Zulassung von Sativex in UK verzögern wird; hier die Kursreaktion:
Dabei ändert das nichts an den langfristigen Aussichten:
Abgesehen vom Marktpotential spricht folgendes für die Aktie:
1. Zulassung in Kanada ist erfolgt, bald stehen dort erste Einkünfte an
2. Potenter Partner (Bayer)
3. Im Gegensatz zu sonstigen Pharma"neuentwicklungen" ist das Risiko äußerst begrenzt, da Cannabis jahrtausedelang erprobt ist und alle (zahlreichen) Versuche, bedeutsame substanzspezifische negative Nebenwirkungen bei realistischer Dosierung nachzuweisen, gescheitert sind.
4. Der Markt ist heiß auf das Produkt
Mehr Infos: http://boards.fool.co.uk/Message.asp?mid=8841281&sort=recomm…
May, 10
GW Pharma loses appeal over cannabis drug
GW Pharmaceuticals (LSE: GWP.L - news) said on Friday that it had lost its appeal against a demand by UK regulators for further data on Sativex, its cannabis-based treatment for multiple sclerosis patients.
The company’s shares, which had fallen 18 per cent earlier in the week on the back of speculation about a lost appeal, dropped a further 14.5p to 81p in early London trading.
GW said the Medicines Commission had decided evidence that Sativex was effective in treating spasticity in MS patients was “not yet sufficiently compelling”.
In December, the Commission, which advises the Medicines and Healthcare products Regulatory Agency called for more evidence on the drug’s efficacy although it had been happy with the quality and safety of the treatment.
GW appealed and the commission considered the case in mid-May.
---------------------
Also wird Sativex bald in Canada losgetreten, aber die frage wäre ob und wann die nötige studie für GB in Auftrag gegeben wird und ob diese dann eine zulassung ermöglicht.
Auf jeden fall mal im auge behalten
toc.
GW Pharma loses appeal over cannabis drug
GW Pharmaceuticals (LSE: GWP.L - news) said on Friday that it had lost its appeal against a demand by UK regulators for further data on Sativex, its cannabis-based treatment for multiple sclerosis patients.
The company’s shares, which had fallen 18 per cent earlier in the week on the back of speculation about a lost appeal, dropped a further 14.5p to 81p in early London trading.
GW said the Medicines Commission had decided evidence that Sativex was effective in treating spasticity in MS patients was “not yet sufficiently compelling”.
In December, the Commission, which advises the Medicines and Healthcare products Regulatory Agency called for more evidence on the drug’s efficacy although it had been happy with the quality and safety of the treatment.
GW appealed and the commission considered the case in mid-May.
---------------------
Also wird Sativex bald in Canada losgetreten, aber die frage wäre ob und wann die nötige studie für GB in Auftrag gegeben wird und ob diese dann eine zulassung ermöglicht.
Auf jeden fall mal im auge behalten
toc.
Die neuen Daten sollen im Frühjahr 2006 vorliegen:
UK Regulatory Update Medicines Commission Confirms Further Clinical Efficacy Data Required
10/06/2005
In December 2004, GW announced that the Committee on Safety of Medicines (CSM), an advisory body to the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), had advised that a further clinical study in Multiple Sclerosis (MS) Spasticity would be required prior to the grant of a UK product licence for Sativex®. At that time, the CSM confirmed that there were no quality or safety issues that would prevent the grant of a product licence.
GW elected to appeal against the CSM’s decision to request a further study to the Medicines Commission, the senior advisory body to the MHRA. The Medicines Commission met in mid May and received a presentation supporting the approval of Sativex by a number of the UK’s leading experts in the field. The appeal was also attended by MS patient representative organisations.
At a meeting with senior officials at the MHRA yesterday afternoon, GW was informed that the Medicines Commission has declined GW’s appeal. The Commission has determined that the evidence of efficacy of Sativex in MS Spasticity is not yet sufficiently compelling.
In December 2004, GW announced its intention to start an additional MS Spasticity study in parallel to the Medicines Commission process. This 280 patient study has now commenced and is due to report results in Spring 2006.
Meanwhile, Sativex has received regulatory approval in Canada in the treatment of Neuropathic Pain in MS. The product is due for Canadian launch imminently.
Professor Mike Barnes, President of the World Federation of Neuro-rehabilitation, Chairman of the Royal College of Physicians Rehabilitation Committee and Professor of Neurological Rehabilitation at the University of Newcastle-upon-tyne, said, “It is my view that there is excellent clinical evidence to support the regulatory approval of Sativex in the UK. I am very disappointed that the Medicines Commission did not follow the recommendation of myself and other leading experts in the treatment of MS. People with MS have considerable unmet medical needs and I am deeply saddened that the regulators do not yet feel in a position to licence this important product.”
The MHRA’s position relates solely to the indication of MS Spasticity. GW will continue to progress its research programme for the use of Sativex in a range of indications. In addition to its MS programme, GW has reported positive Phase III data in Neuropathic Pain and two further neuropathic pain trials are commencing in support of a future regulatory filing in this indication. In addition, having reported a positive Phase III Cancer Pain trial earlier this year, the Company is now planning an additional trial which will provide a registration package for this indication also.
GW remains in a strong financial position, with net cash balances of £16.2m at end of May 2005.
Dr Geoffrey Guy, Executive Chairman, said, “We are disappointed that the UK regulators consider that the efficacy data is not yet sufficiently compelling to make Sativex available to UK patients for the relief of MS Spasticity. Our view, which is shared by prominent experts in the field, is that the existing clinical data shows that Sativex provides an important new treatment option for patients with MS. We know that UK patients will share our disappointment at the decision of the regulators to delay its introduction.
“It is clear from our discussions with the regulatory authority that they recognise the promising results seen to date and they have expressed a desire to provide constructive advice to GW as to how the regulatory requirements may best be met.
“Whilst today’s news is disappointing, the fundamentals for the company remain strong. Sativex will be available on prescription to MS patients in Canada imminently. Furthermore, we have produced a wealth of positive clinical trials data, including seven Phase III trials and have a range of further trials underway. GW also retains its world leading position in cannabinoid science. Today’s setback will only serve to reinforce our determination to bring this important and innovative new medicine to the UK market.”
GW Pharmaceuticals will provide a further update when it announces interim results on the 20 June, 2005.
- Ends -
UK Regulatory Update Medicines Commission Confirms Further Clinical Efficacy Data Required
10/06/2005
In December 2004, GW announced that the Committee on Safety of Medicines (CSM), an advisory body to the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), had advised that a further clinical study in Multiple Sclerosis (MS) Spasticity would be required prior to the grant of a UK product licence for Sativex®. At that time, the CSM confirmed that there were no quality or safety issues that would prevent the grant of a product licence.
GW elected to appeal against the CSM’s decision to request a further study to the Medicines Commission, the senior advisory body to the MHRA. The Medicines Commission met in mid May and received a presentation supporting the approval of Sativex by a number of the UK’s leading experts in the field. The appeal was also attended by MS patient representative organisations.
At a meeting with senior officials at the MHRA yesterday afternoon, GW was informed that the Medicines Commission has declined GW’s appeal. The Commission has determined that the evidence of efficacy of Sativex in MS Spasticity is not yet sufficiently compelling.
In December 2004, GW announced its intention to start an additional MS Spasticity study in parallel to the Medicines Commission process. This 280 patient study has now commenced and is due to report results in Spring 2006.
Meanwhile, Sativex has received regulatory approval in Canada in the treatment of Neuropathic Pain in MS. The product is due for Canadian launch imminently.
Professor Mike Barnes, President of the World Federation of Neuro-rehabilitation, Chairman of the Royal College of Physicians Rehabilitation Committee and Professor of Neurological Rehabilitation at the University of Newcastle-upon-tyne, said, “It is my view that there is excellent clinical evidence to support the regulatory approval of Sativex in the UK. I am very disappointed that the Medicines Commission did not follow the recommendation of myself and other leading experts in the treatment of MS. People with MS have considerable unmet medical needs and I am deeply saddened that the regulators do not yet feel in a position to licence this important product.”
The MHRA’s position relates solely to the indication of MS Spasticity. GW will continue to progress its research programme for the use of Sativex in a range of indications. In addition to its MS programme, GW has reported positive Phase III data in Neuropathic Pain and two further neuropathic pain trials are commencing in support of a future regulatory filing in this indication. In addition, having reported a positive Phase III Cancer Pain trial earlier this year, the Company is now planning an additional trial which will provide a registration package for this indication also.
GW remains in a strong financial position, with net cash balances of £16.2m at end of May 2005.
Dr Geoffrey Guy, Executive Chairman, said, “We are disappointed that the UK regulators consider that the efficacy data is not yet sufficiently compelling to make Sativex available to UK patients for the relief of MS Spasticity. Our view, which is shared by prominent experts in the field, is that the existing clinical data shows that Sativex provides an important new treatment option for patients with MS. We know that UK patients will share our disappointment at the decision of the regulators to delay its introduction.
“It is clear from our discussions with the regulatory authority that they recognise the promising results seen to date and they have expressed a desire to provide constructive advice to GW as to how the regulatory requirements may best be met.
“Whilst today’s news is disappointing, the fundamentals for the company remain strong. Sativex will be available on prescription to MS patients in Canada imminently. Furthermore, we have produced a wealth of positive clinical trials data, including seven Phase III trials and have a range of further trials underway. GW also retains its world leading position in cannabinoid science. Today’s setback will only serve to reinforce our determination to bring this important and innovative new medicine to the UK market.”
GW Pharmaceuticals will provide a further update when it announces interim results on the 20 June, 2005.
- Ends -
mal sehen wie tief fallen die noch heute in usa
[posting]16.887.017 von schakal23 am 14.06.05 16:27:15[/posting]Der Kurs wird in London gemacht, in den USA wird der üblicherweise nur nachvollzogen.
Trading Spotlight
Ich glaube nicht, daß es noch wesentlich weiter runtergeht (wissen tu ich das natürlich auch nicht)
mal sehen wie leuft den so demnächst ich habe mir die 2000st zu 0,99 ergatert
Na, wird doch...
ich habe versucht heute noch ein tausend zulegen hat es nicht geklapt keiner wolte für 0,97 mir was geben
ich habe mich grade im ff bescwert der makler macht die gleische spiel wie gestern er gibt mir die stücke nicht da stehen 1076 st im ask zu 0,99 und ich will die haben mal sehen was die dan machen
na wir sagtes denn die order ist dursch geführt worden scheisse hätte ich gestern angerufen hätte ich die für 0,97 gekrigt.
aber ich hoffe in par monate wäre egal ob ich bei 0,97 oder 0,99 gestiegen bin dan sind wir nähmlich bei 1.40
aber ich hoffe in par monate wäre egal ob ich bei 0,97 oder 0,99 gestiegen bin dan sind wir nähmlich bei 1.40
wer ist das immer in ff mit diesem 1076st die stehen immer wider da. da verkauft jemand immer kleine positionen
na wann gehts hier los???????????????
Also sehe ich das richtig, dass erst im Frühjahr über eine Zulassung in UK entschieden wird?
[posting]17.119.674 von Mindexplorer am 03.07.05 21:17:58[/posting]höchstwahrscheinlich ja.
Ich glaub es ja nicht, jetzt wird man auch in D auf die Aktie aufmerksam 
GW Pharmaceuticals Top-Chance
Quelle: Global Biotech Investing
Datum: 04.07.05
Die Experten von "Global Biotech Investing" sehen nach dem Sell-off bei der GW Pharmaceuticals-Aktie (ISIN GB0030544687/ WKN 693692) eine fantastische Kaufgelegenheit.
Die Analysten von Evolution Securities würden den Titel in ihrer aktuellen Studie mit einem Kursziel von 160 GBp zum Kauf empfehlen. Jedoch sei der Kurs Anfang Juni um 50% eingebrochen.
So habe die britische Aufsichtsbehörde die Zulassung für Sativex, eine Cannabis-Arznei, die vor allem bei Krebsschmerzen Anwendung finden solle, untersagt. Die Behörde verlange weitere Daten, die die Effektivität von Sativex untermauern sollten. Zwar hätten die Behörden in Kanada Sativex als zulassungswürdig eingestuft, jedoch werde dem britischen Markt eine wesentlich größere Bedeutung beigemessen, da hier das Tor für den größeren europäischen Markt liege. Die Analysten von Evolution Securities sähen die Zulassungschancen für den britischen Markt dennoch bei 90%.
Da die Wirkung von Cannabis relativ unstrittig ist, die Nebenwirkungen im Verhältnis zum Nutzen kaum ein Problem darstellen und die Anwendung als Spray ebenfalls problemlos ist, sollte ein Investment in GW Pharmaceuticals strategischen Investoren eine Chance auf dreistellige Gewinne bei kalkulierbaren Risiken bieten, so die Experten von "Global Biotech Investing". Analyse-Datum: 04.07.2005
GW Pharmaceuticals Top-Chance
Quelle: Global Biotech Investing
Datum: 04.07.05
Die Experten von "Global Biotech Investing" sehen nach dem Sell-off bei der GW Pharmaceuticals-Aktie (ISIN GB0030544687/ WKN 693692) eine fantastische Kaufgelegenheit.
Die Analysten von Evolution Securities würden den Titel in ihrer aktuellen Studie mit einem Kursziel von 160 GBp zum Kauf empfehlen. Jedoch sei der Kurs Anfang Juni um 50% eingebrochen.
So habe die britische Aufsichtsbehörde die Zulassung für Sativex, eine Cannabis-Arznei, die vor allem bei Krebsschmerzen Anwendung finden solle, untersagt. Die Behörde verlange weitere Daten, die die Effektivität von Sativex untermauern sollten. Zwar hätten die Behörden in Kanada Sativex als zulassungswürdig eingestuft, jedoch werde dem britischen Markt eine wesentlich größere Bedeutung beigemessen, da hier das Tor für den größeren europäischen Markt liege. Die Analysten von Evolution Securities sähen die Zulassungschancen für den britischen Markt dennoch bei 90%.
Da die Wirkung von Cannabis relativ unstrittig ist, die Nebenwirkungen im Verhältnis zum Nutzen kaum ein Problem darstellen und die Anwendung als Spray ebenfalls problemlos ist, sollte ein Investment in GW Pharmaceuticals strategischen Investoren eine Chance auf dreistellige Gewinne bei kalkulierbaren Risiken bieten, so die Experten von "Global Biotech Investing". Analyse-Datum: 04.07.2005
mensch hab ich garnicht gesehen gesten schade das wir wider runter gehen mit zwei tausend stück
aber was solls die kommen wider wenn die zulassung da ist dan haben wir sofort die zwei€
aber was solls die kommen wider wenn die zulassung da ist dan haben wir sofort die zwei€
wann haben die den zahlen wider ? irgend wann geht hier wider los
seid den anschlag gehen wir nicht mehr hoch es war interessant geworden wäre diese scheiss anschlag nicht
anschlag nicht
[posting]17.293.252 von schakal23 am 20.07.05 23:53:54[/posting]mit den anschlägen hat das wohl eher wenig zu tun. bis zum frühjahr müssen wir uns schon gedulden, erst dann stehen wirklich wichtige news an. (die ersten umsatzzahlen aus can werden aber wohl schon früher für etwas aufwind sorgen).
oh man da müssen wir aber lange warten
Scheinbar tut sich was 
ist ja tot langweillig hier geworden schlimmer als sparbuch
garkeine umsatz nicht hier und nicht in london ich glaube ich steige liber raus da ist garkeine dynamick hier drinn
immer kein umsatz und heute früh aufeinmal das hier und die frage warum der kurs darauf garnicht reagiert
London 70,00 +0,00% 09:00 01.09. 147.525
London 70,00 +0,00% 09:00 01.09. 147.525
Da ist was im Busch
Recent Trades for GW Pharmaceuticals (GWP) Less Trades
Trade Time Date Price Volume Buy/Sell Trade Type
14:22:27 7-SEP-2005 71.07 443,124 *Buy O
15:19:12 7-SEP-2005 70.34 2,146 *Sell O
14:07:00 7-SEP-2005 71.07 100,000 *Buy O
14:04:25 7-SEP-2005 71.00 100,000 *Unknown O
14:19:02 7-SEP-2005 71.00 10,000 *Unknown O
14:00:07 7-SEP-2005 70.25 16 *Sell O
13:09:29 7-SEP-2005 71.00 500 *Unknown O
11:56:13 7-SEP-2005 71.75 600 *Buy O
11:54:50 7-SEP-2005 71.00 4,000 *Unknown O
11:41:45 7-SEP-2005 70.36 1,681 *Sell O
10:19:24 7-SEP-2005 70.36 5,694 *Sell O
10:11:33 7-SEP-2005 71.75 732 *Buy O
10:09:39 7-SEP-2005 70.30 3,020 *Sell O
10:00:10 7-SEP-2005 71.28 1,175 *Buy O
09:21:20 7-SEP-2005 71.75 875 *Buy O
09:11:36 7-SEP-2005 71.00 599 *Unknown O
08:39:20 7-SEP-2005 71.00 10,000 *Unknown O
Recent Trades for GW Pharmaceuticals (GWP) Less Trades
Trade Time Date Price Volume Buy/Sell Trade Type
14:22:27 7-SEP-2005 71.07 443,124 *Buy O
15:19:12 7-SEP-2005 70.34 2,146 *Sell O
14:07:00 7-SEP-2005 71.07 100,000 *Buy O
14:04:25 7-SEP-2005 71.00 100,000 *Unknown O
14:19:02 7-SEP-2005 71.00 10,000 *Unknown O
14:00:07 7-SEP-2005 70.25 16 *Sell O
13:09:29 7-SEP-2005 71.00 500 *Unknown O
11:56:13 7-SEP-2005 71.75 600 *Buy O
11:54:50 7-SEP-2005 71.00 4,000 *Unknown O
11:41:45 7-SEP-2005 70.36 1,681 *Sell O
10:19:24 7-SEP-2005 70.36 5,694 *Sell O
10:11:33 7-SEP-2005 71.75 732 *Buy O
10:09:39 7-SEP-2005 70.30 3,020 *Sell O
10:00:10 7-SEP-2005 71.28 1,175 *Buy O
09:21:20 7-SEP-2005 71.75 875 *Buy O
09:11:36 7-SEP-2005 71.00 599 *Unknown O
08:39:20 7-SEP-2005 71.00 10,000 *Unknown O
heute 7% in london in plus aber leider kann ich die vollumen nicht sehen @crash kanst du bitte das wider rein stellen von heute?
wir steigen langsam aber sicher nach oben hat jemand neue info?
kommisch in D interessiert sich keiner für diese aktie wenn werd das anders?
heute wider starke keufe in london
bald kommt bestimmt was
bald kommt bestimmt was
Eröffnungskurs: 78,50
Geldkurs: 84,75
Briefkurs: 85,25
Kursziel 1J: 76,00
Tagesspanne: 79,88 - 86,25
52W Spanne: 60,00 - 172,00
Volumen: 899.550
Ø Volumen: 285.473
Mkt. Kap.: 9,50 Mrd
KGV (ttm): N/A
GpA (ttm): -12,40
DpA: N/A ()
900.000 st sind heute gehandelt da wissen welche mehr als wir in london sehen wir bald den 100 in london vieleicht schon am wochenende
Geldkurs: 84,75
Briefkurs: 85,25
Kursziel 1J: 76,00
Tagesspanne: 79,88 - 86,25
52W Spanne: 60,00 - 172,00
Volumen: 899.550
Ø Volumen: 285.473
Mkt. Kap.: 9,50 Mrd
KGV (ttm): N/A
GpA (ttm): -12,40
DpA: N/A ()
900.000 st sind heute gehandelt da wissen welche mehr als wir in london sehen wir bald den 100 in london vieleicht schon am wochenende
wir müssen morgen eröffnen mit mendesten 1,25 in ff
moin an die gemeinde !
ich zähl mich ab sofort auch zu den gw pharma investoren, beobachte das teil schon seit langer zeit, wie viele hier bin ich auch von dem papier überzeugt.
über kurze, aber auf jeden fall auf lange sicht sehe ich massig potenzial.
gute fahrt
claud
ich zähl mich ab sofort auch zu den gw pharma investoren, beobachte das teil schon seit langer zeit, wie viele hier bin ich auch von dem papier überzeugt.
über kurze, aber auf jeden fall auf lange sicht sehe ich massig potenzial.
gute fahrt
claud
Sativex®, a Cannabis-Based Medicine, Significantly Reduces Central Neuropathic Pain in People with Multiple Sclerosis
27/09/2005
London, United Kingdom, 27th September 2005: The cannabis based medicine, Sativex®, is effective in reducing central neuropathic pain and sleep disturbance in people with Multiple Sclerosis (MS) in a UK study published today in the medical journal, Neurology1.
This randomised, controlled trial demonstrates that Sativex was significantly superior to placebo in reducing the mean intensity of pain (p=0.005) and sleep disturbance (p=0.003) amongst people with MS1.
The study was conducted in 66 patients, 65% of whom required support to walk or were wheelchair bound and were suffering from moderate to severe central neuropathic pain which had not been alleviated by currently available medications. Patients continued to take their existing medication throughout the trial1.
Sativex was administered as an oromucosal spray allowing flexible dosing which is ideally suited to the variable nature of MS. Sativex was generally well tolerated in the study1.
Dr Carolyn Young, principal investigator and Consultant Neurologist based at the Walton Centre for Neurology and Neurosurgery in Liverpool said, "Central neuropathic pain occurs frequently in people with MS. It can be tremendously debilitating and unresponsive to existing therapies. Our findings demonstrate that Sativex was effective in reducing both central pain in MS and pain-related sleep disturbance in a population with moderate to severe central pain inadequately relieved by existing medication".
Sativex has been developed by UK-based GW Pharmaceuticals plc and is currently approved as a prescription medicine in Canada for the symptomatic relief of neuropathic pain in adults with MS. Sativex is marketed in Canada by Bayer HealthCare. An ongoing clinical trial programme is currently being undertaken to support regulatory approval in the UK. Upon UK approval, Sativex will be exclusively marketed by Bayer HealthCare.
- Ends -
GW Pharmaceuticals plc + 44 (0)1980 557000
Dr Geoffrey Guy, Chairman
Justin Gover, Managing Director
Mark Rogerson, Press and PR + 44 (0)7885 638810
Weber Shandwick Square Mile + 44 (0)20 7067 0700
Kevin Smith
Notes to Editors
Sativex
Sativex is derived from whole plant extracts of two specifically bred cannabis plant varieties. The extracts are combined to produce a standardised formulation containing two major components of cannabis, the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
Sativex is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD.
Central Neuropathic Pain
Neuropathic pain is caused by damage to or dysfunction of the nervous system. It is usually chronic and accompanied by unpleasant burning or shooting sensations, or extreme sensitivity to touch.
It is estimated that at least 2.4% of the world’s population suffers from neuropathic pain2, including over 1.4 million patients in UK.
It is estimated that central neuropathic pain (pain initiated or caused by damage to the central nervous system, i.e.brain or spinal cord) occurs in up to 52% of people with multiple sclerosis3. Up to 32% of patients with MS regard pain among their most severe symptoms4 describing it as frequent, disabling and inadequately managed5.
About GW Pharmaceuticals plc
GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines. GW’s shares are publicly traded on AiM, a market on the London Stock Exchange.
Full details of GW and the company’s clinical trials programme can be found at www.gwpharm.com. GW’s clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems.
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
References
D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005;65:812
Neuropathy Trust 2005. www.neurocentre.com (Source September 2005)
Biovie J. Central Pain. In: Wall PD, Melzack R, eds. Textbook of pain, 4th ed. Hong Kong: Harcourt Publishers Ltd, 1999:879-914
Stenager E, Knudsen L, Jensen K. Acute and chronic pain syndromes in multiple sclerosis. Acta Neurol Scand 1991;84:197-200
Thompson AJ. Symptomatic treatment in multiple sclerosis. Curr Opin Neurol 1998;11(4):305-309
27/09/2005
London, United Kingdom, 27th September 2005: The cannabis based medicine, Sativex®, is effective in reducing central neuropathic pain and sleep disturbance in people with Multiple Sclerosis (MS) in a UK study published today in the medical journal, Neurology1.
This randomised, controlled trial demonstrates that Sativex was significantly superior to placebo in reducing the mean intensity of pain (p=0.005) and sleep disturbance (p=0.003) amongst people with MS1.
The study was conducted in 66 patients, 65% of whom required support to walk or were wheelchair bound and were suffering from moderate to severe central neuropathic pain which had not been alleviated by currently available medications. Patients continued to take their existing medication throughout the trial1.
Sativex was administered as an oromucosal spray allowing flexible dosing which is ideally suited to the variable nature of MS. Sativex was generally well tolerated in the study1.
Dr Carolyn Young, principal investigator and Consultant Neurologist based at the Walton Centre for Neurology and Neurosurgery in Liverpool said, "Central neuropathic pain occurs frequently in people with MS. It can be tremendously debilitating and unresponsive to existing therapies. Our findings demonstrate that Sativex was effective in reducing both central pain in MS and pain-related sleep disturbance in a population with moderate to severe central pain inadequately relieved by existing medication".
Sativex has been developed by UK-based GW Pharmaceuticals plc and is currently approved as a prescription medicine in Canada for the symptomatic relief of neuropathic pain in adults with MS. Sativex is marketed in Canada by Bayer HealthCare. An ongoing clinical trial programme is currently being undertaken to support regulatory approval in the UK. Upon UK approval, Sativex will be exclusively marketed by Bayer HealthCare.
- Ends -
GW Pharmaceuticals plc + 44 (0)1980 557000
Dr Geoffrey Guy, Chairman
Justin Gover, Managing Director
Mark Rogerson, Press and PR + 44 (0)7885 638810
Weber Shandwick Square Mile + 44 (0)20 7067 0700
Kevin Smith
Notes to Editors
Sativex
Sativex is derived from whole plant extracts of two specifically bred cannabis plant varieties. The extracts are combined to produce a standardised formulation containing two major components of cannabis, the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
Sativex is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD.
Central Neuropathic Pain
Neuropathic pain is caused by damage to or dysfunction of the nervous system. It is usually chronic and accompanied by unpleasant burning or shooting sensations, or extreme sensitivity to touch.
It is estimated that at least 2.4% of the world’s population suffers from neuropathic pain2, including over 1.4 million patients in UK.
It is estimated that central neuropathic pain (pain initiated or caused by damage to the central nervous system, i.e.brain or spinal cord) occurs in up to 52% of people with multiple sclerosis3. Up to 32% of patients with MS regard pain among their most severe symptoms4 describing it as frequent, disabling and inadequately managed5.
About GW Pharmaceuticals plc
GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines. GW’s shares are publicly traded on AiM, a market on the London Stock Exchange.
Full details of GW and the company’s clinical trials programme can be found at www.gwpharm.com. GW’s clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems.
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
References
D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005;65:812
Neuropathy Trust 2005. www.neurocentre.com (Source September 2005)
Biovie J. Central Pain. In: Wall PD, Melzack R, eds. Textbook of pain, 4th ed. Hong Kong: Harcourt Publishers Ltd, 1999:879-914
Stenager E, Knudsen L, Jensen K. Acute and chronic pain syndromes in multiple sclerosis. Acta Neurol Scand 1991;84:197-200
Thompson AJ. Symptomatic treatment in multiple sclerosis. Curr Opin Neurol 1998;11(4):305-309
eine gute sache das wegen letzten den anstieg hoffe das so weiter geht
Es kommt Bewegung in die Sache!!!
UK Named Patient Prescribing for Sativex®
15/11/2005
GW announces that it has been informed by the Home Office that the Drugs Minister, Paul Goggins, has confirmed that Sativex® oromucosal spray, its cannabis-based medicine, may be imported from Canada to satisfy its prescription to individual patients in the UK as an unlicensed medicine. This development is in response to enquiries from a number of UK doctors and individual patients who have been in contact with the Home Office to request access to Sativex.
In accordance with the Medicines Act, a medicine which has yet to be licensed in the UK may be prescribed and supplied in response to an unsolicited request to fulfil the special needs of an individual patient under a physician’s direct personal responsibility. The basis on which Sativex may be imported, therefore, is the clinical judgement of doctors in relation to specific nominated patients.
This development follows the approval of Sativex by Health Canada in April 2005. The medicine has been available on prescription in Canada since late June.
More recently, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued to GW a Wholesale Dealer’s (Importation from non-EU countries) Licence, and has not objected to the importation of Sativex under the regulations for importation of medicines unlicensed in the UK.
Sativex will remain a Schedule 1 controlled drug in the UK in line with stated government policy. This means that the prescribing of Sativex can only be permitted under Home Office licence. The Home Office will therefore be developing a licensing regime to fit these circumstances. GW expects to discuss the implementation practicalities with the Home Office over the coming weeks.
Clearance for supply on an unlicensed basis does not affect GW’s plans to seek full regulatory approval from the MHRA for Sativex in the UK. The Company is currently conducting a number of further Phase III trials and is still planning to submit an application for Marketing Authorisation to the MHRA during 2006. Only after such an approval is granted can the product be promoted in the UK.
- Ends -
GW Pharmaceuticals plc
+ 44 (0)1980 557000
Dr Geoffrey Guy, Chairman
Justin Gover, Managing Director
Mark Rogerson, Press and PR
+ 44 (0)7885 638810
Weber Shandwick Square Mile
+ 44 (0)20 7067 0700
Kevin Smith/Yvonne Alexander
About GW Pharmaceuticals plc
GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development program to develop non-smoked cannabis-based prescription medicines. GW’s shares are publicly traded on AiM, a market on the London Stock Exchange.
Full details of GW and the company’s research programme can be found at www.gwpharm.com.
This news release may contain forward-looking statements that reflect GW`s current expectations regarding future events, including the clinical development and regulatory clearance of its 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 GW`s research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and GW`s other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.
UK Named Patient Prescribing for Sativex®
15/11/2005
GW announces that it has been informed by the Home Office that the Drugs Minister, Paul Goggins, has confirmed that Sativex® oromucosal spray, its cannabis-based medicine, may be imported from Canada to satisfy its prescription to individual patients in the UK as an unlicensed medicine. This development is in response to enquiries from a number of UK doctors and individual patients who have been in contact with the Home Office to request access to Sativex.
In accordance with the Medicines Act, a medicine which has yet to be licensed in the UK may be prescribed and supplied in response to an unsolicited request to fulfil the special needs of an individual patient under a physician’s direct personal responsibility. The basis on which Sativex may be imported, therefore, is the clinical judgement of doctors in relation to specific nominated patients.
This development follows the approval of Sativex by Health Canada in April 2005. The medicine has been available on prescription in Canada since late June.
More recently, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued to GW a Wholesale Dealer’s (Importation from non-EU countries) Licence, and has not objected to the importation of Sativex under the regulations for importation of medicines unlicensed in the UK.
Sativex will remain a Schedule 1 controlled drug in the UK in line with stated government policy. This means that the prescribing of Sativex can only be permitted under Home Office licence. The Home Office will therefore be developing a licensing regime to fit these circumstances. GW expects to discuss the implementation practicalities with the Home Office over the coming weeks.
Clearance for supply on an unlicensed basis does not affect GW’s plans to seek full regulatory approval from the MHRA for Sativex in the UK. The Company is currently conducting a number of further Phase III trials and is still planning to submit an application for Marketing Authorisation to the MHRA during 2006. Only after such an approval is granted can the product be promoted in the UK.
- Ends -
GW Pharmaceuticals plc
+ 44 (0)1980 557000
Dr Geoffrey Guy, Chairman
Justin Gover, Managing Director
Mark Rogerson, Press and PR
+ 44 (0)7885 638810
Weber Shandwick Square Mile
+ 44 (0)20 7067 0700
Kevin Smith/Yvonne Alexander
About GW Pharmaceuticals plc
GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development program to develop non-smoked cannabis-based prescription medicines. GW’s shares are publicly traded on AiM, a market on the London Stock Exchange.
Full details of GW and the company’s research programme can be found at www.gwpharm.com.
This news release may contain forward-looking statements that reflect GW`s current expectations regarding future events, including the clinical development and regulatory clearance of its 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 GW`s research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and GW`s other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.
Da steckt heute richtig Volumen hinter !
noch ein paar background-news...
Times Online November 15, 2005
Home Office approves cannabis-based MS drug
By Miles Costello
Multiple Sclerosis sufferers learned today that they can be prescribed a cannabis-based spray treatment for pain relief, even though it is not yet licensed in the UK.
The announcement sent the share price of the company that produces the medicine rocketing on the stock market.
GW Pharmaceuticals, a medical research and development company based in Salisbury, Wiltshire, said it had been told by the Home Office that it would allow doctors to prescribe Sativex to select MS patients, based on their individual needs.
The treatment - which has been found to significantly reduce pain in the central nervous system among those hit by the disease - has until now only been available in Canada.
After receiving approval from the Canadian medical authorities in April, Sativex has been available on prescription there since late June.
The drug will now have to be imported from Canada to the UK, where it will remain a tightly controlled, Schedule 1 drug. There are about 85,000 MS sufferers in the UK, of which around two-thirds are women.
Doctors have wanted to be able to prescribe Sativex to their patients, amid widespread use by MS sufferers of pure cannabis to combat pain relief. Cannabis remains a Class C drug, for which even possession can result in arrest. GW had previously been granted the right to grow the drug legally in Britain for testing and refining purposes.
The approval means Sativex becomes the only cannabis-based drug to become available on prescription in the UK.
"This development is in response to enquiries from a number of UK doctors and individual patients who have been in contact with the Home Office to request access to Sativex," GW Pharmaceuticals said today.
Steve Barker, a spokesman for the Campaign to Legalise Cannabis, said: "It`s great news... I think this will be a relief for the huge number of MS sufferers and thousands of sufferers of chronic pain.
"Presumably it`s a toe in the water as far as the Government is concerned. They`ll want to see how it goes."
Before the Misuse of Drugs Act in 1971, cannabis could be prescribed by GPs. In the 1920s, it was routinely used to treat more than 20 medical conditions.
GW said that now, doctors will only be able to prescribe the drug to patients under licence from the Home Office, which will now develop a licensing regime to accommodate the controversial nature of the ingredients. But the drug should be immediately available to patients, once their GPs have carried out the necessary paperwork.
The company added: "GW expects to discuss the implementation practicalities with the Home Office over the coming weeks. GW, which is still carrying out final stage trials for Sativex, said it would pursue its application for a full UK licence for the drug."
Shares in GW Pharmaceuticals, which is listed on the London Stock Exchange`s junior AIM market, soared following the disclosure of the approval, which should act as a strong boost to the company`s business in the UK.
Having closed last night at 70p, the shares jumped more than 18.5 per cent to 83p, substantially increasing GW`s value, which based on yesterday`s close stood at just under £80 million.
Times Online November 15, 2005
Home Office approves cannabis-based MS drug
By Miles Costello
Multiple Sclerosis sufferers learned today that they can be prescribed a cannabis-based spray treatment for pain relief, even though it is not yet licensed in the UK.
The announcement sent the share price of the company that produces the medicine rocketing on the stock market.
GW Pharmaceuticals, a medical research and development company based in Salisbury, Wiltshire, said it had been told by the Home Office that it would allow doctors to prescribe Sativex to select MS patients, based on their individual needs.
The treatment - which has been found to significantly reduce pain in the central nervous system among those hit by the disease - has until now only been available in Canada.
After receiving approval from the Canadian medical authorities in April, Sativex has been available on prescription there since late June.
The drug will now have to be imported from Canada to the UK, where it will remain a tightly controlled, Schedule 1 drug. There are about 85,000 MS sufferers in the UK, of which around two-thirds are women.
Doctors have wanted to be able to prescribe Sativex to their patients, amid widespread use by MS sufferers of pure cannabis to combat pain relief. Cannabis remains a Class C drug, for which even possession can result in arrest. GW had previously been granted the right to grow the drug legally in Britain for testing and refining purposes.
The approval means Sativex becomes the only cannabis-based drug to become available on prescription in the UK.
"This development is in response to enquiries from a number of UK doctors and individual patients who have been in contact with the Home Office to request access to Sativex," GW Pharmaceuticals said today.
Steve Barker, a spokesman for the Campaign to Legalise Cannabis, said: "It`s great news... I think this will be a relief for the huge number of MS sufferers and thousands of sufferers of chronic pain.
"Presumably it`s a toe in the water as far as the Government is concerned. They`ll want to see how it goes."
Before the Misuse of Drugs Act in 1971, cannabis could be prescribed by GPs. In the 1920s, it was routinely used to treat more than 20 medical conditions.
GW said that now, doctors will only be able to prescribe the drug to patients under licence from the Home Office, which will now develop a licensing regime to accommodate the controversial nature of the ingredients. But the drug should be immediately available to patients, once their GPs have carried out the necessary paperwork.
The company added: "GW expects to discuss the implementation practicalities with the Home Office over the coming weeks. GW, which is still carrying out final stage trials for Sativex, said it would pursue its application for a full UK licence for the drug."
Shares in GW Pharmaceuticals, which is listed on the London Stock Exchange`s junior AIM market, soared following the disclosure of the approval, which should act as a strong boost to the company`s business in the UK.
Having closed last night at 70p, the shares jumped more than 18.5 per cent to 83p, substantially increasing GW`s value, which based on yesterday`s close stood at just under £80 million.
Scheinbar kommt die eigentliche Reaktion auf die News erst heute
Recent Trades for GW Pharmaceuticals (GWP)
Trade Time Date Price Volume Buy/Sell Trade Type
08:50:01 16-NOV-2005 95.00 3,126 *Buy O
08:49:31 16-NOV-2005 95.00 306 *Buy O
08:47:34 16-NOV-2005 93.00 6,000 *Buy O
08:46:59 16-NOV-2005 92.00 5,500 *Buy O
08:46:26 16-NOV-2005 92.00 1,197 *Buy O
08:46:20 16-NOV-2005 92.00 5,341 *Buy O
08:44:40 16-NOV-2005 90.82 1,000 *Buy B
08:44:30 16-NOV-2005 90.75 605 *Buy O
08:44:26 16-NOV-2005 90.82 1,000 *Buy O
08:44:30 16-NOV-2005 90.75 1,114 *Buy O
08:44:30 16-NOV-2005 90.75 1,237 *Buy O
08:40:58 16-NOV-2005 89.25 1,000 *Buy O
08:40:50 16-NOV-2005 89.95 555 *Buy O
08:40:49 16-NOV-2005 90.00 6,000 *Buy O
08:40:42 16-NOV-2005 89.95 3,305 *Buy O
08:39:34 16-NOV-2005 90.00 13,000 *Buy O
08:38:36 16-NOV-2005 89.70 2,197 *Buy O
08:35:25 16-NOV-2005 90.00 10,000 *Buy O
08:34:10 16-NOV-2005 89.95 753 *Buy O
08:31:23 16-NOV-2005 89.00 20,000 *Buy O
Recent Trades for GW Pharmaceuticals (GWP)
Trade Time Date Price Volume Buy/Sell Trade Type
08:50:01 16-NOV-2005 95.00 3,126 *Buy O
08:49:31 16-NOV-2005 95.00 306 *Buy O
08:47:34 16-NOV-2005 93.00 6,000 *Buy O
08:46:59 16-NOV-2005 92.00 5,500 *Buy O
08:46:26 16-NOV-2005 92.00 1,197 *Buy O
08:46:20 16-NOV-2005 92.00 5,341 *Buy O
08:44:40 16-NOV-2005 90.82 1,000 *Buy B
08:44:30 16-NOV-2005 90.75 605 *Buy O
08:44:26 16-NOV-2005 90.82 1,000 *Buy O
08:44:30 16-NOV-2005 90.75 1,114 *Buy O
08:44:30 16-NOV-2005 90.75 1,237 *Buy O
08:40:58 16-NOV-2005 89.25 1,000 *Buy O
08:40:50 16-NOV-2005 89.95 555 *Buy O
08:40:49 16-NOV-2005 90.00 6,000 *Buy O
08:40:42 16-NOV-2005 89.95 3,305 *Buy O
08:39:34 16-NOV-2005 90.00 13,000 *Buy O
08:38:36 16-NOV-2005 89.70 2,197 *Buy O
08:35:25 16-NOV-2005 90.00 10,000 *Buy O
08:34:10 16-NOV-2005 89.95 753 *Buy O
08:31:23 16-NOV-2005 89.00 20,000 *Buy O
und weiter gehts...
[posting]18.934.503 von crashpoet am 22.11.05 10:13:03[/posting]und wie...
Recent Trades for GW Pharmaceuticals (GWP)
Trade Time Date Price Volume Buy/Sell Trade Type
09:13:24 22-NOV-2005 104.00 15,000 *Buy O
09:11:32 22-NOV-2005 102.00 3,000 *Buy O
09:11:02 22-NOV-2005 100.75 1,500 *Sell O
09:10:57 22-NOV-2005 102.00 10,000 *Buy O
09:10:41 22-NOV-2005 101.35 740 *Buy O
09:09:24 22-NOV-2005 100.00 2,000 *Buy O
09:09:00 22-NOV-2005 100.00 7,000 *Buy O
09:06:29 22-NOV-2005 100.00 10,000 *Buy O
09:06:04 22-NOV-2005 100.00 20,000 *Buy O
09:05:49 22-NOV-2005 97.50 5,000 *Sell O
09:05:05 22-NOV-2005 98.80 3,000 *Buy O
09:04:41 22-NOV-2005 97.75 5,000 *Sell O
09:03:07 22-NOV-2005 99.00 5,000 *Buy O
09:02:24 22-NOV-2005 97.70 10,000 *Sell O
09:02:23 22-NOV-2005 97.75 4,000 *Sell O
09:01:50 22-NOV-2005 97.00 27,903 *Sell O
09:00:34 22-NOV-2005 99.00 10,000 *Buy O
08:57:31 22-NOV-2005 99.00 8,500 *Buy O
08:53:05 22-NOV-2005 99.00 5,100 *Buy O
08:52:54 22-NOV-2005 99.00 2,500 *Buy O
Recent Trades for GW Pharmaceuticals (GWP)
Trade Time Date Price Volume Buy/Sell Trade Type
09:13:24 22-NOV-2005 104.00 15,000 *Buy O
09:11:32 22-NOV-2005 102.00 3,000 *Buy O
09:11:02 22-NOV-2005 100.75 1,500 *Sell O
09:10:57 22-NOV-2005 102.00 10,000 *Buy O
09:10:41 22-NOV-2005 101.35 740 *Buy O
09:09:24 22-NOV-2005 100.00 2,000 *Buy O
09:09:00 22-NOV-2005 100.00 7,000 *Buy O
09:06:29 22-NOV-2005 100.00 10,000 *Buy O
09:06:04 22-NOV-2005 100.00 20,000 *Buy O
09:05:49 22-NOV-2005 97.50 5,000 *Sell O
09:05:05 22-NOV-2005 98.80 3,000 *Buy O
09:04:41 22-NOV-2005 97.75 5,000 *Sell O
09:03:07 22-NOV-2005 99.00 5,000 *Buy O
09:02:24 22-NOV-2005 97.70 10,000 *Sell O
09:02:23 22-NOV-2005 97.75 4,000 *Sell O
09:01:50 22-NOV-2005 97.00 27,903 *Sell O
09:00:34 22-NOV-2005 99.00 10,000 *Buy O
08:57:31 22-NOV-2005 99.00 8,500 *Buy O
08:53:05 22-NOV-2005 99.00 5,100 *Buy O
08:52:54 22-NOV-2005 99.00 2,500 *Buy O
Und es geht munter weiter 
Heute bereits mehr als 1000000 Stück in London gehandelt! (Avg. Vol. 222725)
Der Kursverlauf gefällt mir
schönes intraday-reversal
FDA Accepts Investigational New Drug (IND) Application For Sativex(R)
Tuesday January 3, 11:00 pm ET
Sativex(R) To Enter Directly Into Phase III Cancer Pain Trials In United States
LONDON, Jan. 3 /PRNewswire-FirstCall/ -- GW Pharmaceuticals (AiM: GWP) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for Sativex®, a cannabis- derived, oro-mucosal spray composed primarily of tetrahydrocannabinol (THC) and cannabidiol (CBD), a non-psychoactive cannabinoid, for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.
As part of this IND, the FDA has agreed that GW Pharmaceuticals may proceed directly into pivotal Phase III clinical trials in the United States in this very seriously ill patient population.
This IND follows a pre-IND/end of Phase II meeting held with the FDA in June 2005. The FDA has reviewed the extensive quality, safety and efficacy data generated by GW on Sativex® in Europe. In addition, the FDA has provided written guidance on the U.S. Phase III trial protocol. The planned 250 patient, double-blind, randomized placebo controlled study will evaluate the effect of Sativex® in relieving average daily pain, reducing the use of breakthrough opioid medications, improving the quality of sleep and relevant aspects of quality of life among other outcome measures.
Pain is one of the common symptoms associated with cancer and each year more than 250,000 terminal cancer patients in the USA take opioids for pain relief.(1) Approximately 75% of advanced cancer patients experience pain.(2)
"A previous Phase III clinical study showed that Sativex® achieved a statistically significant improvement in pain relief in terminally ill cancer patients," says researcher, Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City. "Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex® will be critical in defining their role."
GW has completed a positive Phase III study in Europe in 177 patients with cancer pain. The trial was a multi-center double-blind, randomized, placebo- controlled parallel group study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine). In addition to study medication, all patients remained on their existing opioid and other analgesic medication during the trial. In this study, Sativex® achieved a statistically significant improvement in comparison with placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of the study. A responder analysis showed that approximately 40% of patients on Sativex® showed a greater than 30% improvement in their pain (p=0.024).
Sativex® is a pharmaceutical product standardized by both composition and dose that is supplied in small vials as an oromucosal spray. Sativex® is thought to act via cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.(3) These receptors are distributed throughout the pain pathways of the nervous system, and their activation is known to reduce pain in relevant pain models.
"Sativex® seems to be a very promising treatment option for patients whose pain does not respond to current analgesics," said Dr. Nathaniel Katz, Assistant Professor of Anesthesia, Tufts University School of Medicine. "The clinical data thus far suggest that many patients who have been suffering with intractable pain may gain significant benefit from the use of Sativex®. I welcome GW expanding its research program into the U.S."
GW expects to carry out two pivotal Phase III trials in cancer pain in the U.S. prior to filing a U.S. regulatory submission. The U.S. development plan also includes other smaller scale supporting studies. This clinical program is likely to commence in late 2006. A U.S. regulatory submission could reasonably be expected to occur 24-36 months thereafter.
"We are very excited about the FDA`s acceptance of our IND," said Dr. Geoffrey Guy, Executive Chairman, GW Pharmaceuticals. "GW believes that Sativex® represents a first-in-class valuable new treatment option for the many advanced cancer patients in the United States whose suffering has not been adequately managed by current opioid pain medications."
Dr. Guy added, "The acceptance by the FDA of this Phase III IND is a significant achievement for the company. It is a recognition of the technical excellence of GW`s team, the sound scientific basis for Sativex®, the quality of the product and the extent of the quality, safety and efficacy data generated to date. It has, for some time, been GW`s strategy to generate extensive data on Sativex® in Europe before embarking on discussions with FDA. This strategy has now provided the optimum outcome in allowing the Company to proceed directly into U.S. Phase III clinical trials, thus compressing the overall potential timelines to filing a U.S. regulatory submission. We are delighted that the FDA has accepted our approach."
In April 2005, GW announced that Sativex® had been granted regulatory approval in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis.
Sativex® has already been subject to an extensive pharmaceutical development program, in which more than 2000 patients and subjects have been involved in clinical trials.
About GW
GW was founded in 1998 and listed on the Alternative Investment Market (AIM) of the London Stock Exchange in June 2001. Operating under license from the UK Home Office, the company is developing cannabis-derived pharmaceutical products for patients with multiple sclerosis, spinal cord injury, rheumatoid arthritis, neuropathic pain, cancer pain and other severe medical conditions. GW maintains control over all aspects of the development process: botanical research, cultivation, extraction, formulation and medication delivery.
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 is dedicated to developing treatment options that alleviate pain symptoms in patients who suffer from serious ailments.
Forward-looking statement
This news release may contain forward-looking statements that reflect the Company`s current expectations regarding future events, including development and regulatory clearance of the Company`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 Company`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.
For media inquires contact:
MS&L, Lolita Verny
212-468-4336
Lolita.Verny@mslpr.com
GW Pharmaceuticals, Mark Rogerson
011 44 7885 638810
1) University of Chicago Chronicle. "New drug promises pain relief for many terminal cancer patients." Last accessed 21 December 2005. Available at http://chronicle.uchicago.edu/000217/drug.shtml.
2) National Cancer Institute. "Communicating About Cancer Pain." Last accessed 21 December 2005. Available at http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_…
3) Health Canada. "Approval of SATIVEX® with Conditions Fact Sheet." Last accessed 16 December 2005. Available at http://www.hc-sc.gc.ca/dhp- mps/prodpharma/notices-avis/conditions/sativex_factsheet_e.html.
--------------------------------------------------------------------------------
Source: GW Pharmaceuticals
Tuesday January 3, 11:00 pm ET
Sativex(R) To Enter Directly Into Phase III Cancer Pain Trials In United States
LONDON, Jan. 3 /PRNewswire-FirstCall/ -- GW Pharmaceuticals (AiM: GWP) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for Sativex®, a cannabis- derived, oro-mucosal spray composed primarily of tetrahydrocannabinol (THC) and cannabidiol (CBD), a non-psychoactive cannabinoid, for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.
As part of this IND, the FDA has agreed that GW Pharmaceuticals may proceed directly into pivotal Phase III clinical trials in the United States in this very seriously ill patient population.
This IND follows a pre-IND/end of Phase II meeting held with the FDA in June 2005. The FDA has reviewed the extensive quality, safety and efficacy data generated by GW on Sativex® in Europe. In addition, the FDA has provided written guidance on the U.S. Phase III trial protocol. The planned 250 patient, double-blind, randomized placebo controlled study will evaluate the effect of Sativex® in relieving average daily pain, reducing the use of breakthrough opioid medications, improving the quality of sleep and relevant aspects of quality of life among other outcome measures.
Pain is one of the common symptoms associated with cancer and each year more than 250,000 terminal cancer patients in the USA take opioids for pain relief.(1) Approximately 75% of advanced cancer patients experience pain.(2)
"A previous Phase III clinical study showed that Sativex® achieved a statistically significant improvement in pain relief in terminally ill cancer patients," says researcher, Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City. "Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex® will be critical in defining their role."
GW has completed a positive Phase III study in Europe in 177 patients with cancer pain. The trial was a multi-center double-blind, randomized, placebo- controlled parallel group study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine). In addition to study medication, all patients remained on their existing opioid and other analgesic medication during the trial. In this study, Sativex® achieved a statistically significant improvement in comparison with placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of the study. A responder analysis showed that approximately 40% of patients on Sativex® showed a greater than 30% improvement in their pain (p=0.024).
Sativex® is a pharmaceutical product standardized by both composition and dose that is supplied in small vials as an oromucosal spray. Sativex® is thought to act via cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.(3) These receptors are distributed throughout the pain pathways of the nervous system, and their activation is known to reduce pain in relevant pain models.
"Sativex® seems to be a very promising treatment option for patients whose pain does not respond to current analgesics," said Dr. Nathaniel Katz, Assistant Professor of Anesthesia, Tufts University School of Medicine. "The clinical data thus far suggest that many patients who have been suffering with intractable pain may gain significant benefit from the use of Sativex®. I welcome GW expanding its research program into the U.S."
GW expects to carry out two pivotal Phase III trials in cancer pain in the U.S. prior to filing a U.S. regulatory submission. The U.S. development plan also includes other smaller scale supporting studies. This clinical program is likely to commence in late 2006. A U.S. regulatory submission could reasonably be expected to occur 24-36 months thereafter.
"We are very excited about the FDA`s acceptance of our IND," said Dr. Geoffrey Guy, Executive Chairman, GW Pharmaceuticals. "GW believes that Sativex® represents a first-in-class valuable new treatment option for the many advanced cancer patients in the United States whose suffering has not been adequately managed by current opioid pain medications."
Dr. Guy added, "The acceptance by the FDA of this Phase III IND is a significant achievement for the company. It is a recognition of the technical excellence of GW`s team, the sound scientific basis for Sativex®, the quality of the product and the extent of the quality, safety and efficacy data generated to date. It has, for some time, been GW`s strategy to generate extensive data on Sativex® in Europe before embarking on discussions with FDA. This strategy has now provided the optimum outcome in allowing the Company to proceed directly into U.S. Phase III clinical trials, thus compressing the overall potential timelines to filing a U.S. regulatory submission. We are delighted that the FDA has accepted our approach."
In April 2005, GW announced that Sativex® had been granted regulatory approval in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis.
Sativex® has already been subject to an extensive pharmaceutical development program, in which more than 2000 patients and subjects have been involved in clinical trials.
About GW
GW was founded in 1998 and listed on the Alternative Investment Market (AIM) of the London Stock Exchange in June 2001. Operating under license from the UK Home Office, the company is developing cannabis-derived pharmaceutical products for patients with multiple sclerosis, spinal cord injury, rheumatoid arthritis, neuropathic pain, cancer pain and other severe medical conditions. GW maintains control over all aspects of the development process: botanical research, cultivation, extraction, formulation and medication delivery.
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 is dedicated to developing treatment options that alleviate pain symptoms in patients who suffer from serious ailments.
Forward-looking statement
This news release may contain forward-looking statements that reflect the Company`s current expectations regarding future events, including development and regulatory clearance of the Company`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 Company`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.
For media inquires contact:
MS&L, Lolita Verny
212-468-4336
Lolita.Verny@mslpr.com
GW Pharmaceuticals, Mark Rogerson
011 44 7885 638810
1) University of Chicago Chronicle. "New drug promises pain relief for many terminal cancer patients." Last accessed 21 December 2005. Available at http://chronicle.uchicago.edu/000217/drug.shtml.
2) National Cancer Institute. "Communicating About Cancer Pain." Last accessed 21 December 2005. Available at http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_…
3) Health Canada. "Approval of SATIVEX® with Conditions Fact Sheet." Last accessed 16 December 2005. Available at http://www.hc-sc.gc.ca/dhp- mps/prodpharma/notices-avis/conditions/sativex_factsheet_e.html.
--------------------------------------------------------------------------------
Source: GW Pharmaceuticals
da kommt was...
Moin !
sind hier irgendjemandem neuigkeiten bekannt ? ich sprech nicht von den "normalen" nachrichten..
danke
claud
sind hier irgendjemandem neuigkeiten bekannt ? ich sprech nicht von den "normalen" nachrichten..
danke
claud
ich weiss zwar nicht was, aber irgendwas ist heute nachmittag passiert.
Reefer madness
Apr 27th 2006
From The Economist print edition
Marijuana is medically useful, whether politicians like it or not
Getty Images
IF CANNABIS were unknown, and bioprospectors were suddenly to find it in some remote mountain crevice, its discovery would no doubt be hailed as a medical breakthrough. Scientists would praise its potential for treating everything from pain to cancer, and marvel at its rich pharmacopoeia—many of whose chemicals mimic vital molecules in the human body. In reality, cannabis has been with humanity for thousands of years and is considered by many governments (notably America's) to be a dangerous drug without utility. Any suggestion that the plant might be medically useful is politically controversial, whatever the science says. It is in this context that, on April 20th, America's Food and Drug Administration (FDA) issued a statement saying that smoked marijuana has no accepted medical use in treatment in the United States.
The statement is curious in a number of ways. For one thing, it overlooks a report made in 1999 by the Institute of Medicine (IOM), part of the National Academy of Sciences, which came to a different conclusion. John Benson, a professor of medicine at the University of Nebraska who co-chaired the committee that drew up the report, found some sound scientific information that supports the medical use of marijuana for certain patients for short periods—even for smoked marijuana.
This is important, because one of the objections to marijuana is that, when burned, its smoke contains many of the harmful things found in tobacco smoke, such as carcinogenic tar, cyanide and carbon monoxide. Yet the IOM report supports what some patients suffering from multiple sclerosis, AIDS and cancer—and their doctors—have known for a long time. This is that the drug gives them medicinal benefits over and above the medications they are already receiving, and despite the fact that the smoke has risks. That is probably why several studies show that many doctors recommend smoking cannabis to their patients, even though they are unable to prescribe it. Patients then turn to the black market for their supply.
Another reason the FDA statement is odd is that it seems to lack common sense. Cannabis has been used as a medicinal plant for millennia. In fact, the American government actually supplied cannabis as a medicine for some time, before the scheme was shut down in the early 1990s. Today, cannabis is used all over the world, despite its illegality, to relieve pain and anxiety, to aid sleep, and to prevent seizures and muscle spasms. For example, two of its long-advocated benefits are that it suppresses vomiting and enhances appetite—qualities that AIDS patients and those on anti-cancer chemotherapy find useful. So useful, in fact, that the FDA has licensed a drug called Marinol, a synthetic version of one of the active ingredients of marijuana—delta-9-tetrahydrocannabinol (THC). Unfortunately, many users of Marinol complain that it gets them high (which isn't what they actually want) and is not nearly as effective, nor cheap, as the real weed itself.
This may be because Marinol is ingested into the stomach, meaning that it is metabolised before being absorbed. Or it may be because the medicinal benefits of cannabis come from the synergistic effect of the multiplicity of chemicals it contains.
Just what have you been smoking?
THC is the best known active ingredient of cannabis, but by no means the only one. At the last count, marijuana was known to contain nearly 70 different cannabinoids, as THC and its cousins are collectively known. These chemicals activate receptor molecules in the human body, particularly the cannabinoid receptors on the surfaces of some nerve cells in the brain, and stimulate changes in biochemical activity. But the details often remain vague—in particular, the details of which molecules are having which clinical effects.
More clinical research would help. In particular, the breeding of different varieties of cannabis, with different mixtures of cannabinoids, would enable researchers to find out whether one variety works better for, say, multiple sclerosis-related spasticity while another works for AIDS-related nerve pain. However, in the United States, this kind of work has been inhibited by marijuana's illegality and the unwillingness of the Drug Enforcement Administration (DEA) to license researchers to grow it for research.
Since 2001, for example, Lyle Craker, a researcher at the University of Massachusetts, has been trying to obtain a licence from the DEA to grow cannabis for use in clinical research. After years of prevarication, and pressure on the DEA to make a decision, Dr Craker's application was turned down in 2004. Today, the saga continues and a DEA judge (who presides over a quasi-judicial process within the agency) is hearing an appeal, which could come to a close this summer. Dr Craker says that his situation is like that described in Joseph Heller's novel, “Catch 22”. “We can say that this has no medical benefit because no tests have been done, and then we refuse to let you do any tests. The US has gotten into a bind, it has made cannabis out to be such a villain that people blindly say ‘no’.”
Anjuli Verma, the advocacy director of the American Civil Liberties Union (ACLU), a group helping Dr Craker fight his appeal, says that even if the DEA judge rules in their favour, the agency's chief administrator can still decide whether to allow the application. And, as she points out, the DEA is a political organisation charged with enforcing the drug laws. So, she says, the ACLU is in this for the long haul, and is already prepared for another appeal—one that would be heard in a federal court in the normal judicial system.
Ms Verma's view of the FDA's statement is that other arms of government are putting pressure on the agency to make a public pronouncement that conforms with drug ideology as promulgated by the White House, the DEA and a number of vocal anti-cannabis congressmen. In particular, the federal government has been rattled in recent years by the fact that eleven states have passed laws allowing the medical use of marijuana. In this context it is notable that the FDA's statement emphasises that it is smoked marijuana which has not gone through the process necessary to make it a prescription drug. (Nor would it be likely to, with all of the harmful things in the smoke.) The statement's emphasis on smoked marijuana is important because it leaves the door open for the agency to approve other methods of delivery.
High hopes
Donald Abrams, a professor of clinical medicine at the University of California, San Francisco, has been working on one such option. He is allowed by the National Institute on Drug Abuse (the only legal supplier of cannabis in the United States) to do research on a German nebuliser that heats cannabis to the point of vaporisation, where it releases its cannabinoids without any of the smoke of a spliff, and with fewer carcinogens.
That is encouraging. But it does not address the wider question of which cannabinoids are doing what. For that, researchers need to be able to do their own plant-breeding programmes.
In America, this is impossible. But it is happening in other countries. In 1997, for example, the British government asked Geoffrey Guy, the executive chairman and founder of GW Pharmaceuticals, to come up with a programme to develop cannabis into a pharmaceutical product.
In the intervening years, GW has assembled a “library” of more than 300 varieties of cannabis, and obtained plant-breeder's rights on between 30 and 40 of these. It has found the genes that control cannabinoid production and can specify within strict limits the seven or eight cannabinoids it is most interested in. And it knows how to crossbreed its strains to get the mixtures it wants.
Nor is this knowledge merely academic. Last year, GW gained approval in Canada for the use of its first drug, Sativex, which is an extract of cannabis sprayed under the tongue that is designed for the relief of neuropathic pain in multiple sclerosis. Sativex is also available to a more limited degree in Spain and Britain, and is in clinical trials for other uses, such as relieving the pain of rheumatoid arthritis.
At the start of this year, the company made the first step towards gaining regulatory approval for Sativex in America when the FDA accepted it as a legitimate candidate for clinical trials. But there is still a long way to go.
And that delay raises an important point. Once available, a well-formulated and scientifically tested drug should knock a herbal medicine into a cocked hat. No one would argue for chewing willow bark when aspirin is available. But, in the meantime, there is unmet medical need that, as the IOM report pointed out, could easily and cheaply be met—if the American government cared more about suffering and less about posturing.
Apr 27th 2006
From The Economist print edition
Marijuana is medically useful, whether politicians like it or not
Getty Images
IF CANNABIS were unknown, and bioprospectors were suddenly to find it in some remote mountain crevice, its discovery would no doubt be hailed as a medical breakthrough. Scientists would praise its potential for treating everything from pain to cancer, and marvel at its rich pharmacopoeia—many of whose chemicals mimic vital molecules in the human body. In reality, cannabis has been with humanity for thousands of years and is considered by many governments (notably America's) to be a dangerous drug without utility. Any suggestion that the plant might be medically useful is politically controversial, whatever the science says. It is in this context that, on April 20th, America's Food and Drug Administration (FDA) issued a statement saying that smoked marijuana has no accepted medical use in treatment in the United States.
The statement is curious in a number of ways. For one thing, it overlooks a report made in 1999 by the Institute of Medicine (IOM), part of the National Academy of Sciences, which came to a different conclusion. John Benson, a professor of medicine at the University of Nebraska who co-chaired the committee that drew up the report, found some sound scientific information that supports the medical use of marijuana for certain patients for short periods—even for smoked marijuana.
This is important, because one of the objections to marijuana is that, when burned, its smoke contains many of the harmful things found in tobacco smoke, such as carcinogenic tar, cyanide and carbon monoxide. Yet the IOM report supports what some patients suffering from multiple sclerosis, AIDS and cancer—and their doctors—have known for a long time. This is that the drug gives them medicinal benefits over and above the medications they are already receiving, and despite the fact that the smoke has risks. That is probably why several studies show that many doctors recommend smoking cannabis to their patients, even though they are unable to prescribe it. Patients then turn to the black market for their supply.
Another reason the FDA statement is odd is that it seems to lack common sense. Cannabis has been used as a medicinal plant for millennia. In fact, the American government actually supplied cannabis as a medicine for some time, before the scheme was shut down in the early 1990s. Today, cannabis is used all over the world, despite its illegality, to relieve pain and anxiety, to aid sleep, and to prevent seizures and muscle spasms. For example, two of its long-advocated benefits are that it suppresses vomiting and enhances appetite—qualities that AIDS patients and those on anti-cancer chemotherapy find useful. So useful, in fact, that the FDA has licensed a drug called Marinol, a synthetic version of one of the active ingredients of marijuana—delta-9-tetrahydrocannabinol (THC). Unfortunately, many users of Marinol complain that it gets them high (which isn't what they actually want) and is not nearly as effective, nor cheap, as the real weed itself.
This may be because Marinol is ingested into the stomach, meaning that it is metabolised before being absorbed. Or it may be because the medicinal benefits of cannabis come from the synergistic effect of the multiplicity of chemicals it contains.
Just what have you been smoking?
THC is the best known active ingredient of cannabis, but by no means the only one. At the last count, marijuana was known to contain nearly 70 different cannabinoids, as THC and its cousins are collectively known. These chemicals activate receptor molecules in the human body, particularly the cannabinoid receptors on the surfaces of some nerve cells in the brain, and stimulate changes in biochemical activity. But the details often remain vague—in particular, the details of which molecules are having which clinical effects.
More clinical research would help. In particular, the breeding of different varieties of cannabis, with different mixtures of cannabinoids, would enable researchers to find out whether one variety works better for, say, multiple sclerosis-related spasticity while another works for AIDS-related nerve pain. However, in the United States, this kind of work has been inhibited by marijuana's illegality and the unwillingness of the Drug Enforcement Administration (DEA) to license researchers to grow it for research.
Since 2001, for example, Lyle Craker, a researcher at the University of Massachusetts, has been trying to obtain a licence from the DEA to grow cannabis for use in clinical research. After years of prevarication, and pressure on the DEA to make a decision, Dr Craker's application was turned down in 2004. Today, the saga continues and a DEA judge (who presides over a quasi-judicial process within the agency) is hearing an appeal, which could come to a close this summer. Dr Craker says that his situation is like that described in Joseph Heller's novel, “Catch 22”. “We can say that this has no medical benefit because no tests have been done, and then we refuse to let you do any tests. The US has gotten into a bind, it has made cannabis out to be such a villain that people blindly say ‘no’.”
Anjuli Verma, the advocacy director of the American Civil Liberties Union (ACLU), a group helping Dr Craker fight his appeal, says that even if the DEA judge rules in their favour, the agency's chief administrator can still decide whether to allow the application. And, as she points out, the DEA is a political organisation charged with enforcing the drug laws. So, she says, the ACLU is in this for the long haul, and is already prepared for another appeal—one that would be heard in a federal court in the normal judicial system.
Ms Verma's view of the FDA's statement is that other arms of government are putting pressure on the agency to make a public pronouncement that conforms with drug ideology as promulgated by the White House, the DEA and a number of vocal anti-cannabis congressmen. In particular, the federal government has been rattled in recent years by the fact that eleven states have passed laws allowing the medical use of marijuana. In this context it is notable that the FDA's statement emphasises that it is smoked marijuana which has not gone through the process necessary to make it a prescription drug. (Nor would it be likely to, with all of the harmful things in the smoke.) The statement's emphasis on smoked marijuana is important because it leaves the door open for the agency to approve other methods of delivery.
High hopes
Donald Abrams, a professor of clinical medicine at the University of California, San Francisco, has been working on one such option. He is allowed by the National Institute on Drug Abuse (the only legal supplier of cannabis in the United States) to do research on a German nebuliser that heats cannabis to the point of vaporisation, where it releases its cannabinoids without any of the smoke of a spliff, and with fewer carcinogens.
That is encouraging. But it does not address the wider question of which cannabinoids are doing what. For that, researchers need to be able to do their own plant-breeding programmes.
In America, this is impossible. But it is happening in other countries. In 1997, for example, the British government asked Geoffrey Guy, the executive chairman and founder of GW Pharmaceuticals, to come up with a programme to develop cannabis into a pharmaceutical product.
In the intervening years, GW has assembled a “library” of more than 300 varieties of cannabis, and obtained plant-breeder's rights on between 30 and 40 of these. It has found the genes that control cannabinoid production and can specify within strict limits the seven or eight cannabinoids it is most interested in. And it knows how to crossbreed its strains to get the mixtures it wants.
Nor is this knowledge merely academic. Last year, GW gained approval in Canada for the use of its first drug, Sativex, which is an extract of cannabis sprayed under the tongue that is designed for the relief of neuropathic pain in multiple sclerosis. Sativex is also available to a more limited degree in Spain and Britain, and is in clinical trials for other uses, such as relieving the pain of rheumatoid arthritis.
At the start of this year, the company made the first step towards gaining regulatory approval for Sativex in America when the FDA accepted it as a legitimate candidate for clinical trials. But there is still a long way to go.
And that delay raises an important point. Once available, a well-formulated and scientifically tested drug should knock a herbal medicine into a cocked hat. No one would argue for chewing willow bark when aspirin is available. But, in the meantime, there is unmet medical need that, as the IOM report pointed out, could easily and cheaply be met—if the American government cared more about suffering and less about posturing.
The benefits of Cannabis (sprayed under the tongue)
By h.b.
Wed, 14 Jun 2006, 08:12
Email this article
Printer friendly page
EDITORIAL COMMENT - Healthcare in Spain is organised on a regional basis. While the region of Cataluña goes to the polls on Sunday to vote on their new regional powers, the Health Service in the region is already well advanced into a study into the use of Cannabis to reduce pain.
The study began at the start of the year using a Cannabis spray, applied under the tongue, called Sativex. The medicine is made by a British company GW Pharmaceutical, and has come imported to Cataluña from Canada where the production is authorised for the control of pain from multiple sclerosis. Now too the Catalan company Almirall has been given a licence to develop the product which contains more than 400 of the active ingredients found in Marihuana.
63 patients are taking part in the therapeutic use of the drug. The volunteers are suffering pain, Aids or Cancer, and feel they have not responded to traditional therapies.
Cannabis also has a reputation for helping to control vomiting and side effects from other treatments, such as chemotherapy. The Catalan study here is much wider with 300 people taking part, but first the doctors have to establish, with a controlled smaller initial group, what dosage of cannabis is needed to be effective, without in itself proving toxic. "The volunteers are suffering pain, Aids or Cancer, and feel they have not responded to traditional therapies"
Although in the early stages, already eight participants in the study have decided to stop because of the adverse effects they have suffered. Here it seems each person is different, and so each one is keeping a diary where they can record how they are feeling after each treatment. Some are already saying pain is down by some 40%, but that in itself has proven frustrating for some who had hoped for greater relief.
Others say they want to self-medicate themselves, using the real plant or hashish resin, but of course in those circumstances the scientific control goes out the window. There is no control on dosage, or indeed on product quality. Some of the Catalan doctors would like to use cannabis leaves in a study, as has been done in Holland, but that is proving difficult to get past the Spanish Ministry of Health.
Around 90 researchers are taking part in the Catalan project, the first of its type in Spain. The Generalitat, the Catalan Regional Government, says that if the findings are positive they may move to try and change the law in Spain to allow the medicinal use of Cannabis. So far only Canada and Holland have such a law. Here the IU left wing coalition has already put forward a proposal calling for the legal production, distribution and consumption of the drug for therapeutic use.
The first official results from the Catalan study will be published in the Autumn.
© typicallyspanish.com
By h.b.
Wed, 14 Jun 2006, 08:12
Email this article
Printer friendly page
EDITORIAL COMMENT - Healthcare in Spain is organised on a regional basis. While the region of Cataluña goes to the polls on Sunday to vote on their new regional powers, the Health Service in the region is already well advanced into a study into the use of Cannabis to reduce pain.
The study began at the start of the year using a Cannabis spray, applied under the tongue, called Sativex. The medicine is made by a British company GW Pharmaceutical, and has come imported to Cataluña from Canada where the production is authorised for the control of pain from multiple sclerosis. Now too the Catalan company Almirall has been given a licence to develop the product which contains more than 400 of the active ingredients found in Marihuana.
63 patients are taking part in the therapeutic use of the drug. The volunteers are suffering pain, Aids or Cancer, and feel they have not responded to traditional therapies.
Cannabis also has a reputation for helping to control vomiting and side effects from other treatments, such as chemotherapy. The Catalan study here is much wider with 300 people taking part, but first the doctors have to establish, with a controlled smaller initial group, what dosage of cannabis is needed to be effective, without in itself proving toxic. "The volunteers are suffering pain, Aids or Cancer, and feel they have not responded to traditional therapies"
Although in the early stages, already eight participants in the study have decided to stop because of the adverse effects they have suffered. Here it seems each person is different, and so each one is keeping a diary where they can record how they are feeling after each treatment. Some are already saying pain is down by some 40%, but that in itself has proven frustrating for some who had hoped for greater relief.
Others say they want to self-medicate themselves, using the real plant or hashish resin, but of course in those circumstances the scientific control goes out the window. There is no control on dosage, or indeed on product quality. Some of the Catalan doctors would like to use cannabis leaves in a study, as has been done in Holland, but that is proving difficult to get past the Spanish Ministry of Health.
Around 90 researchers are taking part in the Catalan project, the first of its type in Spain. The Generalitat, the Catalan Regional Government, says that if the findings are positive they may move to try and change the law in Spain to allow the medicinal use of Cannabis. So far only Canada and Holland have such a law. Here the IU left wing coalition has already put forward a proposal calling for the legal production, distribution and consumption of the drug for therapeutic use.
The first official results from the Catalan study will be published in the Autumn.
© typicallyspanish.com
Something's going on...
BRANDAKTUELL:
GW Files Sativex® for Approval in Selected European Countries for MS Spasticity
05/09/2006
Porton Down, UK, 5 September 2006 - GW Pharmaceuticals plc (AIM: GWP) (“GW” or “the Company”) today announces that it has filed a regulatory submission in selected European countries for Sativex®, its cannabinoid spray medicine. The filing is for the symptomatic relief of spasticity in people with multiple sclerosis (MS), a patient group with a significant unmet medical need.
The filing has been made under the “decentralised procedure” in the UK, Spain, Denmark and the Netherlands. Under this procedure, the UK is acting as Reference Member State and will consult with the three other countries. If successful, a filing under the decentralised procedure would lead to the simultaneous approval of Sativex in these countries for the MS spasticity indication.
Upon approval, Sativex will be marketed in the UK by Bayer HealthCare and in the rest of Europe by Almirall.
Commenting on today’s announcement, Dr Stephen Wright, GW’s R&D Director, said:
“We now have a sizeable body of positive clinical data to support the efficacy and safety of Sativex in MS spasticity. This is a complex data package and we have therefore reviewed the complete dossier with our marketing partners and discussed it in detail with a number of European regulators. These meetings have provided constructive and positive feedback. The conclusion of GW and its marketing partners, taking into account the views of the regulators, as well as the unmet needs of this target patient group, is that this body of data warrants serious regulatory evaluation.”
Dr Geoffrey Guy, Executive Chairman of GW, added:
“This filing is one element of a broad-based regulatory strategy for Sativex, which is designed to maximise the opportunities for Sativex as well as to manage the risks associated with its development. Beyond the filing today in MS spasticity, the Phase III clinical trials programme continues and will provide further sets of clinical data to support additional regulatory filings in separate indications. This approach is aimed at creating several independent opportunities to obtain regulatory approvals for Sativex in the coming years.”
There will be a conference call for analysts today at 9.00am. Please contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. A recording of this call will be accessible on the press releases page in the investor relations section of the GW website (www.gwpharm.com) later today.
Enquiries:
For GW:
GW Pharmaceuticals plc
Today: +44 (0)20 7831 3113
Dr Geoffrey Guy , Chairman
Thereafter: + 44 (0)1980 557000
Justin Gover , Managing Director
Mark Rogerson , Press and PR
Tel: + 44 (0)7885 638810
Financial Dynamics
Tel: +44 (0)20 7831 3113
David Yates, Ben Atwell
For Bayer:
Sylvia Barber
Tel: +44 (0) 1635 563607
For Almirall:
Weber Shandwick Healthcare
Natalie Murphy, Brian Tjugum
Tel: +44 (0) 20 7067 0000
Notes to Editors
Background to the submission
The current submission is supported by a body of clinical data in approximately 700 patients with MS spasticity, and includes two pivotal Phase III trials as well as two supportive trials. Data from the first pivotal trial, which showed positive results across all primary analyses, were announced in June 2004 and reviewed by the UK regulatory authority. The UK regulators subsequently advised that this single pivotal trial would need to be supplemented by a further pivotal clinical study in MS spasticity in order to obtain a product licence for Sativex in this indication.
The second pivotal trial in MS spasticity, the results of which were reported in March 2006, showed a consistent positive treatment effect to the first pivotal trial. A pooled analysis of the full spasticity data-set also showed a positive effect for Sativex in this patient population. In the second pivotal trial, the per protocol analysis achieved statistical significance, whereas the outcome in the Intention to Treat (ITT) analysis was positive but non-significant. GW therefore stated at that time that it wished to consult with a number of different regulatory authorities in Europe, as well as with its European marketing partners, Bayer and Almirall, to determine whether it should move forward with a filing in this indication.
In the last few months, a series of positive meetings have taken place with officials from selected target European regulatory authorities. These meetings were attended by GW as well as its marketing partners and were aimed at providing advice as to the appropriateness of the data package for regulatory submission. These meetings are based on a preliminary view of the data and, as such, any advice provided is always subject to a detailed assessment in any future application. As a result of these meetings, GW and its marketing partners were in full agreement that the regulatory dossier should be submitted at this time.
Regulatory strategy for Sativex
This regulatory submission is part of a comprehensive strategy to secure regulatory approvals for Sativex across multiple indications in Europe, North America and the rest of the world. In addition to MS spasticity, Sativex is also in Phase III trials for three further separate indications: peripheral neuropathic pain, MS neuropathic pain and cancer pain. It is intended that, in accordance with conventional regulatory requirements, each regulatory submission for each target indication is supported by two pivotal Phase III clinical trials.
Indication: MS Neuropathic Pain
Sativex is approved in Canada in the indication of MS Neuropathic Pain under Health Canada’s Notice of Compliance with conditions policy.
GW has recently commenced a second pivotal Phase III study in this indication. This study supplements a completed positive pivotal Phase III study as well as a number of supportive studies. This second pivotal study, which is expected to report results in approximately one year, is intended to complete a data package to support a regulatory submission in Europe in this indication. In addition, the study will be submitted to the Canadian regulators in order to achieve a full Notice of Compliance.
Indication: Peripheral Neuropathic Pain
GW is now completing two pivotal Phase III studies in this indication, which are due to report results at the end of this year. These studies, together with a number of completed positive supportive studies, are intended to provide a data package to support a regulatory submission in Europe in this indication.
Indication: Cancer Pain
In January 2006, GW received permission from the US regulatory authority, the Food and Drug Administration (FDA) to commence Phase III trials in the US in the cancer pain indication. This follows the results of a positive Phase III trial carried out in Europe. Preparations to commence the first of two pivotal Phase III trials in this indication are well underway. Two pivotal Phase III trials in this indication will be carried out to provide a regulatory submission in both the US and in Europe.
About GW Pharmaceuticals
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under licence from the UK Home Office, the Company is developing cannabis-derived pharmaceutical products for patients with multiple sclerosis, neuropathic pain, cancer pain, spinal cord injury, rheumatoid arthritis, and other severe medical conditions.
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 is dedicated to developing treatment options that alleviate pain and other neurological symptoms in patients who suffer from serious ailments.
For further information, please visit the Company’s website: www.gwpharm.com
About Almirall
Almirall is a consolidated international pharmaceutical company that researches, develops and commercialises its own R&D and licensed drugs with the aim of improving people’s health and quality of life.
Almirall is to invest 750 million euros in R&D over the next five years. The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD, psoriasis and rheumatoid arthritis.
Almirall, whose headquarters are in Barcelona (Spain), has a staff of over 3200 people, 500 of whom work in R&D and with approximately 1000 working internationally in Almirall´s affiliate companies.
Almirall´s products are currently present in approximately 100 countries. The company has direct presence in Europe and Latin America via affiliates.
For further information please visit the website at: www.almirall.es
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Haematology/Cardiology; Oncology and Primary Care. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
This news release may contain forward-looking statements that reflect GW's current expectations regarding future events, including the clinical development and regulatory clearance of 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 GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and GW’s other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.
GW Files Sativex® for Approval in Selected European Countries for MS Spasticity
05/09/2006
Porton Down, UK, 5 September 2006 - GW Pharmaceuticals plc (AIM: GWP) (“GW” or “the Company”) today announces that it has filed a regulatory submission in selected European countries for Sativex®, its cannabinoid spray medicine. The filing is for the symptomatic relief of spasticity in people with multiple sclerosis (MS), a patient group with a significant unmet medical need.
The filing has been made under the “decentralised procedure” in the UK, Spain, Denmark and the Netherlands. Under this procedure, the UK is acting as Reference Member State and will consult with the three other countries. If successful, a filing under the decentralised procedure would lead to the simultaneous approval of Sativex in these countries for the MS spasticity indication.
Upon approval, Sativex will be marketed in the UK by Bayer HealthCare and in the rest of Europe by Almirall.
Commenting on today’s announcement, Dr Stephen Wright, GW’s R&D Director, said:
“We now have a sizeable body of positive clinical data to support the efficacy and safety of Sativex in MS spasticity. This is a complex data package and we have therefore reviewed the complete dossier with our marketing partners and discussed it in detail with a number of European regulators. These meetings have provided constructive and positive feedback. The conclusion of GW and its marketing partners, taking into account the views of the regulators, as well as the unmet needs of this target patient group, is that this body of data warrants serious regulatory evaluation.”
Dr Geoffrey Guy, Executive Chairman of GW, added:
“This filing is one element of a broad-based regulatory strategy for Sativex, which is designed to maximise the opportunities for Sativex as well as to manage the risks associated with its development. Beyond the filing today in MS spasticity, the Phase III clinical trials programme continues and will provide further sets of clinical data to support additional regulatory filings in separate indications. This approach is aimed at creating several independent opportunities to obtain regulatory approvals for Sativex in the coming years.”
There will be a conference call for analysts today at 9.00am. Please contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. A recording of this call will be accessible on the press releases page in the investor relations section of the GW website (www.gwpharm.com) later today.
Enquiries:
For GW:
GW Pharmaceuticals plc
Today: +44 (0)20 7831 3113
Dr Geoffrey Guy , Chairman
Thereafter: + 44 (0)1980 557000
Justin Gover , Managing Director
Mark Rogerson , Press and PR
Tel: + 44 (0)7885 638810
Financial Dynamics
Tel: +44 (0)20 7831 3113
David Yates, Ben Atwell
For Bayer:
Sylvia Barber
Tel: +44 (0) 1635 563607
For Almirall:
Weber Shandwick Healthcare
Natalie Murphy, Brian Tjugum
Tel: +44 (0) 20 7067 0000
Notes to Editors
Background to the submission
The current submission is supported by a body of clinical data in approximately 700 patients with MS spasticity, and includes two pivotal Phase III trials as well as two supportive trials. Data from the first pivotal trial, which showed positive results across all primary analyses, were announced in June 2004 and reviewed by the UK regulatory authority. The UK regulators subsequently advised that this single pivotal trial would need to be supplemented by a further pivotal clinical study in MS spasticity in order to obtain a product licence for Sativex in this indication.
The second pivotal trial in MS spasticity, the results of which were reported in March 2006, showed a consistent positive treatment effect to the first pivotal trial. A pooled analysis of the full spasticity data-set also showed a positive effect for Sativex in this patient population. In the second pivotal trial, the per protocol analysis achieved statistical significance, whereas the outcome in the Intention to Treat (ITT) analysis was positive but non-significant. GW therefore stated at that time that it wished to consult with a number of different regulatory authorities in Europe, as well as with its European marketing partners, Bayer and Almirall, to determine whether it should move forward with a filing in this indication.
In the last few months, a series of positive meetings have taken place with officials from selected target European regulatory authorities. These meetings were attended by GW as well as its marketing partners and were aimed at providing advice as to the appropriateness of the data package for regulatory submission. These meetings are based on a preliminary view of the data and, as such, any advice provided is always subject to a detailed assessment in any future application. As a result of these meetings, GW and its marketing partners were in full agreement that the regulatory dossier should be submitted at this time.
Regulatory strategy for Sativex
This regulatory submission is part of a comprehensive strategy to secure regulatory approvals for Sativex across multiple indications in Europe, North America and the rest of the world. In addition to MS spasticity, Sativex is also in Phase III trials for three further separate indications: peripheral neuropathic pain, MS neuropathic pain and cancer pain. It is intended that, in accordance with conventional regulatory requirements, each regulatory submission for each target indication is supported by two pivotal Phase III clinical trials.
Indication: MS Neuropathic Pain
Sativex is approved in Canada in the indication of MS Neuropathic Pain under Health Canada’s Notice of Compliance with conditions policy.
GW has recently commenced a second pivotal Phase III study in this indication. This study supplements a completed positive pivotal Phase III study as well as a number of supportive studies. This second pivotal study, which is expected to report results in approximately one year, is intended to complete a data package to support a regulatory submission in Europe in this indication. In addition, the study will be submitted to the Canadian regulators in order to achieve a full Notice of Compliance.
Indication: Peripheral Neuropathic Pain
GW is now completing two pivotal Phase III studies in this indication, which are due to report results at the end of this year. These studies, together with a number of completed positive supportive studies, are intended to provide a data package to support a regulatory submission in Europe in this indication.
Indication: Cancer Pain
In January 2006, GW received permission from the US regulatory authority, the Food and Drug Administration (FDA) to commence Phase III trials in the US in the cancer pain indication. This follows the results of a positive Phase III trial carried out in Europe. Preparations to commence the first of two pivotal Phase III trials in this indication are well underway. Two pivotal Phase III trials in this indication will be carried out to provide a regulatory submission in both the US and in Europe.
About GW Pharmaceuticals
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under licence from the UK Home Office, the Company is developing cannabis-derived pharmaceutical products for patients with multiple sclerosis, neuropathic pain, cancer pain, spinal cord injury, rheumatoid arthritis, and other severe medical conditions.
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 is dedicated to developing treatment options that alleviate pain and other neurological symptoms in patients who suffer from serious ailments.
For further information, please visit the Company’s website: www.gwpharm.com
About Almirall
Almirall is a consolidated international pharmaceutical company that researches, develops and commercialises its own R&D and licensed drugs with the aim of improving people’s health and quality of life.
Almirall is to invest 750 million euros in R&D over the next five years. The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD, psoriasis and rheumatoid arthritis.
Almirall, whose headquarters are in Barcelona (Spain), has a staff of over 3200 people, 500 of whom work in R&D and with approximately 1000 working internationally in Almirall´s affiliate companies.
Almirall´s products are currently present in approximately 100 countries. The company has direct presence in Europe and Latin America via affiliates.
For further information please visit the website at: www.almirall.es
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Haematology/Cardiology; Oncology and Primary Care. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
This news release may contain forward-looking statements that reflect GW's current expectations regarding future events, including the clinical development and regulatory clearance of 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 GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and GW’s other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.
Italy allows use of cannabis for therapeutic use
dpa German Press Agency
Published: Thursday October 19, 2006
Rome- Reversing anti-drugs policies enforced by Italy's previous centre-right administration, Romano Prodi's government Thursday approved the use of cannabis-based drugs for therapeutic use. "We are talking about pain-relief therapy. This has nothing to do with smoking joints," Health Minister Livia Turco told reporters after a cabinet meeting in Rome.
The new rules mean AIDS and cancer patients will be able to take prescription drugs based on marijuana.
"These drugs are already in use in Canada, Switzerland and Holland," Turco said.
Earlier this year, the government of former premier Silvio Berlusconi tightened the screws on the consumption of illegal drugs, introducing lengthy prison sentences for those found in possession of even small quantities of recreational drugs, such as cannabis and hashish.
Centre-left lawmakers at the time vowed to relax penalties on drugs consumption once in power.
© 2006 dpa German Press Agency
dpa German Press Agency
Published: Thursday October 19, 2006
Rome- Reversing anti-drugs policies enforced by Italy's previous centre-right administration, Romano Prodi's government Thursday approved the use of cannabis-based drugs for therapeutic use. "We are talking about pain-relief therapy. This has nothing to do with smoking joints," Health Minister Livia Turco told reporters after a cabinet meeting in Rome.
The new rules mean AIDS and cancer patients will be able to take prescription drugs based on marijuana.
"These drugs are already in use in Canada, Switzerland and Holland," Turco said.
Earlier this year, the government of former premier Silvio Berlusconi tightened the screws on the consumption of illegal drugs, introducing lengthy prison sentences for those found in possession of even small quantities of recreational drugs, such as cannabis and hashish.
Centre-left lawmakers at the time vowed to relax penalties on drugs consumption once in power.
© 2006 dpa German Press Agency
Antwort auf Beitrag Nr.: 24.734.925 von crashpoet am 20.10.06 09:39:04Die Nachricht scheint in UK noch gar nicht im Umlauf zu sein und wird -laut google-News-Suche- bislang nur von einer Quelle explizit im Zusammenhang mit Sativex genannt.
Die Reaktion in London steht also noch aus.
Die Reaktion in London steht also noch aus.
Ist noch jemand investiert ?
Es gibt wohl vermehrt Insiderkäufe in den letzten Wochen.....
Es gibt wohl vermehrt Insiderkäufe in den letzten Wochen.....
wenn mich nicht alles täuscht, ist hier dieses frühjahr erntezeit
ANSCHNALLEN - ES GEHT LOS!!!GW and Otsuka Announce Major Long Term Strategic Cannabinoid Alliance
14/02/2007
London, UK; Princeton, NJ, USA; Tokyo, Japan; 14 February 2007: GW Pharmaceuticals plc (AIM: GWP) and Otsuka Pharmaceutical Co., Ltd. today announce that they have entered into a major long term strategic cannabinoid alliance.
The relationship has commenced with the signing of an exclusive license and development agreement to develop and market Sativex®, GW's lead product, in the United States. The companies are also in detailed discussions with a view to entering into a cannabinoid research collaboration in the field of Central Nervous System (CNS) disorders and cancer treatment in order to research, develop and commercialize a range of other early stage cannabinoid product opportunities.
The Otsuka Pharmaceutical Group has placed significant emphasis on the research of CNS disorders for the past 27 years. Otsuka's lead product in the field of CNS ranks among the top seven product launches in industry history and the No. 1 product launch since 2002. Worldwide revenues from this product increased from $1.3bn in 2005 to over $1.9bn in 2006. The Group is privately owned, comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. It earned revenues of $6.8 billion in fiscal 2005, ranking it the 26th largest pharmaceutical company in the world1. Otsuka is continuing to expand its CNS specialty sales force presence in the US.
Sativex US License
Under the terms of the license agreement, GW has granted Otsuka an exclusive license to develop and market Sativex, GW’s lead product, in the US. GW will be responsible for the manufacture and supply of Sativex to Otsuka. The agreement is subject to Hart Scott Rodino clearance in the US.
The financial terms of this agreement include total milestone payments to GW of up to $273m as well as a long term commercial supply price and royalty. Otsuka will pay GW a signature fee of $18m. In addition, Otsuka will bear the costs of all US development activities for Sativex in the treatment of cancer pain, additional indications, and future formulations.
GW and Otsuka will jointly oversee all US clinical development and regulatory activities. For the first cancer pain indication, GW will be responsible for carrying out such activities, at Otsuka’s cost. GW will also continue to be the holder of the IND until the filing of a New Drug Application, which will be in Otsuka’s name. Otsuka will assume development and regulatory responsibility for the second and any subsequent indications.
In 2006, the Food & Drug Administration (FDA) permitted Sativex to enter directly into late stage development in the US for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications. GW and Otsuka currently plan for the first US pivotal efficacy clinical trial to be a Phase II/III cancer pain dose ranging study, to commence this year.
Commenting on Sativex, Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City, and principal investigator of the first planned US Sativex study said, "A previous Phase III clinical study showed that Sativex achieved a statistically significant improvement in pain relief in terminally ill cancer patients. There are 3.9 million cancer patients in the US, of which 2.5 million suffer pain. Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex will be critical in defining their role."
Cannabinoid Research Collaboration
Under the proposed cannabinoid research collaboration, which is currently under detailed discussion and is expected to be formalized in a separate agreement later in the year, Otsuka would fund the evaluation of a range of cannabinoids as drug candidates within the field of CNS and cancer treatment, with a view to selecting the most promising candidates for full clinical development, regulatory approval and global commercialization. Products selected for commercialization would be the subject of a license from GW. Under the terms of this license, Otsuka would fund the global development of selected products and GW would receive commercially reasonable financial terms.
Dr Geoffrey Guy, GW's Chairman, said, "This agreement represents a landmark event in the history of GW. Not only have we secured the development and marketing of our lead product, Sativex, in the world’s largest market, we have also selected a strategic partner that will allow us to extend our cannabinoid pipeline. Otsuka has an excellent US commercial track record and a world leading CNS science base. We are delighted to be working with Otsuka to fulfill our ambition of developing a range of novel cannabinoid medicines to meet serious unmet medical needs."
Taro Iwamoto, PhD, President & COO, Otsuka Pharmaceutical Development & Commercialization, Inc., said, "Otsuka is delighted to be entering into this strategic relationship with GW. Otsuka's scientists consider cannabinoids to be a significant potential source of new medicines, and as world leading pioneers in this field, GW represents the ideal partner for Otsuka. Otsuka is committed to maximizing the potential of Sativex in the US market and looks forward to exploring a range of longer term cannabinoid product opportunities. We are confident that this is the beginning of a highly productive and valuable relationship for both companies."
There will be a conference call for analysts today at 8.30am GMT. 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:
For GW:
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, Nicola Daley
For Otsuka:
US Enquiries
Debbie Kaufmann Tel: +1 240 683 3568
Europe Enquiries
Alison Ross Tel: +44 1895 207 7122
Japan Enquiries
Hideki Shirai Tel: +81 3 3292 0021
Notes to Editors
About Otsuka Pharmaceutical Co., Ltd
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "Otsuka - people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment of disease and consumer products for the maintenance of everyday health. The Otsuka Pharmaceutical Group comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US $6.8 billion in consolidated annual revenues in fiscal 2005. The Group has R&D facilities in Japan (Osaka and Tokushima), EU (Frankfurt) and US (Rockville, MD). Its commercial operations are headquartered in US (Rockville, MD and Princeton, NJ), EU (UK) and Japan (Tokyo). For additional information, visit www.otsuka-global.com
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. GW has to date entered into two additional Sativex license agreements – with Bayer HealthCare in the UK and Canada, and with Almirall in Europe (ex-UK). These agreements together provide payments to GW totaling up to £79m ($156m) as well as significant long term supply price provisions. For further information, please visit www.gwpharm.com
About Sativex
Sativex is an investigational product presented as a pump action oro-mucosal spray, which delivers a pharmaceutical formulation containing delta 9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Each 100µL spray contains 2.7mg THC and 2.5mg CBD.
Sativex is standardized by both composition and dose and is supplied in small spray vials. Sativex is thought to act via cannabinoid receptors that are distributed throughout the central nervous system and in immune cellsi. These receptors are distributed throughout the pain pathways of the nervous system, and their activation is known to reduce pain in relevant pain models.
Sativex showed positive results in a completed Phase III study in Europe in 177 patients with cancer pain. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine). In addition to study medication, all patients remained on their existing opioid and other analgesic medication during the trial. In this study, Sativex achieved a statistically significant improvement in comparison with placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of the study. A responder analysis showed that approximately 40% of patients on Sativex showed a greater than 30% improvement in their pain (p=0.024).
Outside the US, Sativex is approved and marketed in Canada for the symptomatic relief of central neuropathic pain in Multiple Sclerosis, and is the subject of an ongoing regulatory submission in Canada for the relief of cancer pain. Sativex is also the subject of an ongoing regulatory application in four selected European countries for the symptomatic relief of spasticity in MS.
About Cannabinoids
The cannabinoid (CB) receptor system is a complex and far-reaching system which has only started to become understood in the last decade or so. To date, CB1 and CB2 receptors have been identified and cloned. Initially, the chemicals which affect these receptors ("cannabinoids") were identified only within the cannabis plant, but extensive scientific investigation has now elaborated a series of endogenous chemicals which maintain this 'endocannabinoid system'. These endogenous cannabinoids are produced in human tissues, exert their actions within those tissues and are then destroyed locally. This allows the system to function in a fine-tuning, modulatory role, and abnormalities of the endocannabinoid system have now been found in several important diseases. Originally, it was believed that these receptors acted largely within the brain, but it is becoming increasingly clear that they are present at many different sites, in many different body systems.
The importance of the integrity of this system of receptors in maintaining several critical areas of mental and physical well-being is becoming clearer because of the type of research that GW and its collaborators are performing. Equally, this research work has identified several important disease areas where the administration of cannabinoids as medicines may lead to desirable therapeutic consequences. Cannabinoid modulators are showing promise in chronic painful conditions, in movement disorders, and in disorders of cell proliferation such as cancer. Furthermore, the role of cannabinoids in the brain may offer therapeutic promise in disorders of behaviour and mood. This is an area of active scientific discovery and therapeutic research which may deliver a range of new treatments to meet unmet medical needs.
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.
1 Pharmaceutical Executive, May 2006
i Health Canada
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