ENDLICH!!!! Jetzt geht es UP!!!! - 500 Beiträge pro Seite

[crashpoet]

Hat lange gedauert, aber jetzt wird alles gut :-)

GW receives Qualifying Notice for approval in Canada for Sativex®

21/12/2004

GW Pharmaceuticals announces that Health Canada, the Canadian regulatory authority, has issued a Qualifying Notice for the approval of Sativex®, a cannabis-based medicinal extract product.

Sativex will initially be indicated in Canada for the relief of neuropathic pain in Multiple Sclerosis (“MS”).

GW filed its Sativex application with Health Canada under the Notice of Compliance with conditions (NOC/c) policy. The Qualifying Notice confirms that Sativex qualifies to be considered for approval and sets out the conditions and post-approval undertakings upon which the marketing authorization for Sativex can be granted. The conditions for Sativex’s approval are in accordance with standard guidance provided by the regulator for NOC/c approvals and include a commitment to ongoing clinical research.

The regulatory submission for Sativex was filed with Health Canada in May 2004. Health Canada has completed its regulatory review in line with its 200 day review target.

GW is required to respond and accept the conditions within 30 days. Following this, Health Canada review this response, subject to a 30 day review target. Should the response be acceptable, Health Canada can then be expected to proceed to finalise the marketing authorisation.

Sativex has been developed by GW and will be exclusively marketed in Canada by the Pharmaceuticals Division of Bayer HealthCare.

Sativex is a whole plant medicinal cannabis extract containing TetranabinexTM (tetrahydrocannabinol or THC) and NabidiolexTM (cannabidiol or CBD) as its principal components. The medicine is administered by means of a spray into the mouth.

Approximately 50,000 people in Canada are diagnosed with MS.

Following the initial approval for Sativex in the relief of neuropathic pain in MS, GW expects to make further applications in Canada for the use of Sativex in additional indications, including pain in other conditions.

Dr Geoffrey Guy, Executive Chairman of GW, said, “We are delighted to receive this Qualifying Notice from Health Canada and look forward to receiving regulatory approval for Sativex in Canada in the early part of 2005. This approval will be a major milestone for GW and for people with Multiple Sclerosis who have long awaited a prescription cannabis-based medicine for the treatment of neuropathic pain. We view Canada as an important target market for Sativex and look forward to working towards product launch with our partner Bayer.

“Health Canada has processed its regulatory review in just seven months and we are grateful to them for this rapid turnaround time. Sativex will be the first prescription cannabis-based medicine and we believe that the pragmatism shown by Health Canada in their review reflects a welcome recognition of the clinical need in MS patients for Sativex.”

- Ends -

Enquiries:

GW Pharmaceuticals plc (44) 1980 557000
Dr Geoffrey Guy, Chairman
Mark Rogerson, Press and PR (44) 7885 638810

Weber Shandwick SquareMile (44) 20 7067 0700
Sarah Macleod

[crashpoet]

WKN 693692

GW Pharma expects okay for cannabis medicine

LONDON (Reuters) - Biotechnology company GW Pharmaceuticals (LSE: GWP.L - news) <GWP.L> says it has had its cannabis-based medicine tipped for approval for the first time, with Canadian regulators considering giving the go ahead to its Sativex drug for sufferers of multiple sclerosis.

The news comes just weeks after British regulators said they wanted more evidence about the benefits of the non-smoked drug used to treat the central nervous system disease, delaying its approval in the UK and battering GW Pharma`s shares.

"As far as I`m aware, it`s the first approval for a prescription cannabis medicine anywhere," a spokesman for the firm told Reuters on Tuesday.

Canada has confirmed that Sativex qualifies to be considered for approval. GW is required to respond and accept conditions within 30 days. If the response is acceptable, the regulator will proceed to finalise the marketing authorisation.

GW Pharma said it expected full regulatory approval by early next year.

The medicine, administered by means of a spray into the mouth, will be exclusively marketed in Canada by Germany`s Bayer <BAYG.DE>, the firm said.

GW grows thousands of marijuana plants at a secret location in the English countryside, having been granted a dispensation by the government to use the plant for medical research. But Sativex has hit a series of delays with regulators.

[Knollebauer]

wow Spray statt Tüte
is ja auch besser für die Lunge

[alex1975]

mal spaß beiseite: kannte die company bis eben gar nicht, ist aber ne interessante meldung - könnte was gehen...

[crashpoet]

Auf das FETTGEDRUCKTE achten!

GW Pharma cannabis drug tipped for approval

By Sonya Dowsett

LONDON (Reuters) - Biotech firm GW Pharmaceuticals (LSE: GWP.L - news) ` cannabis-based medicine has been tipped for approval for the first time, with Canadian regulators giving the go-ahead for its multiple sclerosis drug.

The news comes just weeks after British regulators said they wanted more evidence about the benefits of the drug, which is used to treat the central nervous system disease, delaying its approval in the UK and battering GW Pharma`s <GWP.L> shares.

"As far as I`m aware, it`s the first approval for a prescription cannabis medicine anywhere," a spokesman for the firm told Reuters on Tuesday.

Shares in the firm jumped as much as 9.5 percent, although they retraced a little to change hands at 113-1/2p, up 8.1 percent. They had lost around a third of their value since the start of December when UK regulators asked for more studies.

Canada has confirmed that Sativex qualifies to be considered for approval. GW is required to respond and accept conditions within 30 days. If the response is acceptable, the regulator will proceed to finalise the marketing authorisation.

Analysts said the Canadian system for drug approval meant the rest of the process was little more than a formality. GW Pharma said it expected full approval by early next year.

"Under the Canadian system, full approval should be relatively straightforward from here," said Jon Senior, analyst at Evolution Beeson Gregory, who rates the stock an "add". He said the relatively modest gains in the wake of the Canadian news meant the stock looked good value at these levels.

The medicine, administered by means of a spray into the mouth, will be exclusively marketed in Canada by Germany`s Bayer <BAYG.DE>, the firm said.

GW grows thousands of marijuana plants at a secret location in the English countryside, having been granted a dispensation by the government to use the plant for medical research.

The firm had hoped for UK approval to come through last year, but the drug has been held up by a series of regulatory delays. The latest UK delay could put back the launch of the drug in this country by at least six months.

[alex1975]

ja, das nenn ich kurssprung mit ansage - die frage ist nur, wann das gehandelte volumen mal ansteigt!

[crashpoet]

das volumen in london geht doch

ist halt witrklich ein nebenwert.

[crashpoet]

Researchers find marijuana may help Alzheimer`s patients

LONDON (AFX) - The active ingredient in marijuana may slow the progress of Alzheimer`s disease, according to research published in the Journal of Neuroscience, BBC Online reported.
Researchers at Madrid`s Complutense University and the Cajal Institute found that a synthetic version of the compound may reduce inflammation associated with Alzheimer`s and thus help to prevent mental degeneration.
The scientists compared the brain tissue of patients who died from Alzheimer`s disease with that of healthy people who had died at a similar age, and found fewer brain cell receptors for cannabinoids in the diseased tissue.
They also injected rats with the amyloid protein that forms Alzheimer`s plaques, and found better mental functioning in rats treated with cannabinoids.
Only one UK pharmaceutical company is licensed to research pharmaceuticals derived from marijuana. GW Pharmaceuticals (LSE: GWP.L - news) is developing cannabis-derived medicines for treating pain and muscle problems in multiple sclerosis patients.

[crashpoet]

Monday April 11, 04:00 PM
Visiongain Analyses Cannabinoid Market: A Potential Blockbuster?
By Business Wire




The latest visiongain report investigates wether the cannabinoids market has the potential to become a blockbuster by 2010. The report, "Cannabinoids: A Potential Blockbuster?" states at present only 2 approved cannabinoid drugs exist on the market: Marinol (Dronabinol) and Nabilone. Both are approved for the control of chemotherapy-induced nausea and vomiting. Marinol is additionally approved as an appetite stimulant for appetite loss/ anorexia associated with HIV/AIDS. Whilst Marinol is
approved for use in the US, Nabilone does not have FDA approval, severely curtailing its revenue potential.

Visiongain values the current cannabinoid market in 2005 at $110.5 million. This value is the combined gloabl revenues of Marinol, Nabilone and generic Dronabinol in Germany. This is a 6.3% growth increase from 2004, where revenues totalled $104 million. By 2010 sales of these products could reach a potential of just under $200 million.

By 2006, the cannabinoid market is expected to transform from today`s limited, controversial, niche market. The next coming months will witness the arrival of the world`s first whole-cannabis plant derived pharmaceutical- Sativex- from the innovative cannabinoid company GW Pharmaceuticals (LSE: GWP.L - news) . Sativex is expected to reach the Canadian neuropathic pain Multiple Sclerosis (MS) market, and by the end of 2005, the UK`S-MS -associated spasticity market.

"Sativex is expected to generate revenues of $200 million in its first six months following its 2005 launch," says Zoe Downes, visiongain`s pharmaceutical analyst. "By 2010, Sativex should be marketed in the US where profits of $575 million can be expected". With these revenues Sativex will dominate the cannabinoid market.

Acomplia, (Rimonabant) by Sanofi-Aventis (Paris: FR0000130460 - news) will be another major new comer to the market. Acomplia is expected to gain approval for the antiobesity/smoking cessation markets by the end of 2005. Acomplia is also undergoing Phase II studies for alcohol withdrawal. Revenues will grow steadily until 2010, where they could generate up to $175 million.

The fact that Marinol was rescheduled by the DEA from Schedule II to Schedule III in 1999, increasing patient availability, highlights the shifiting attitude of cannabinoids as valuable therapeutics. Marinol is now classed within the same group as codeine and anabolic steroids as an addictive drug. Visiongain thinks that this is a key milestone for the cannabinoids group in gaining blockbuster status. It may also be a deciding factor as to why Big Pharma is now showing interest in developing cannabinoid candidate portfolios.

If you are interested in an overview of cannabinoids: a potential blockbuster - Please send an email to Senh Ip [e-mail] including: full name, Title of publication, contact telephone number, Email, and details of where you saw this release. Upon receipt of this information, an overview will be emailed to you. Also view: http://www.epharmaceuticalnews.com/Products/4/201/visiongain… Cannaboids-A-potential-blockbuster.html (Due to its length, this URL may need to be copied/pasted into your Internet browser`s address field. Remove the extra space if one exists.)

Background:

Visiongain is one of the fastest growing and most innovative independent media companies in Europe today. Based in London, UK, visiongain produce a host of business-2-business conferences, newsletters, management reports and E-Zines focusing on the Financial markets, the Pharmaceutical, Telecoms industries and currently the Defence sector.

Visiongain publish reports produced by their in-house analysts of qualified experts in their field. Visiongain have firmly established themselves as the first port-of-call for the business professional, who needs independent, high quality, original material to rely and depend on.

Visiongain also have an event division, b2b Conferences, works in tandem with their analytical reports to provide a forum for key issues within the Telecoms and Pharmaceutical professionals.

For more Pharmaceutical information, please contact our website on:

Http://www.epharmaceuticalnews.com

For information on visiongain, please visit the website: Http://www.visiongain.com

[[KERN]Codex]

interessant!