Sativex (Cannabis) gegen Multiple Sklerose zugelassen! - 500 Beiträge pro Seite

[BrauchGeld]

Hi

GW PHARMACEUTICAL


Erste zulassung in canada mitte des jahres folgt U.K..
Man erwartet schon für dieses jahr rund 200mio$ umsatz.

GW Pharmaceuticals plc
(`GW` or `the Company`)

GW Announces Regulatory Approval of Sativex(R) in Canada

GW announces that Sativex(R) has been granted regulatory approval in Canada for
the symptomatic relief of neuropathic pain in multiple sclerosis.

Dr Geoffrey Guy, Executive Chairman, said, `We are delighted that Sativex has
received regulatory approval in Canada. This event marks the world`s first
approval of a cannabis derived medicine. This first regulatory approval has been
obtained by GW in just over six years since the Company`s development programme
commenced, a highly significant achievement. We are now working with our
Canadian marketing partner, Bayer, towards the launch of Sativex throughout
Canada in late Spring.`

The full text of a joint statement released today with Bayer Healthcare, follows
below:

HEALTH CANADA FIRST TO APPROVE A NOVEL CANNABIS DERIVED PHARMACEUTICAL TREATMENT
FOR PEOPLE WITH MULTIPLE SCLEROSIS

TORONTO, Ontario -- (19 April 2005) - Health Canada has approved Sativex(R)
(Cannabis sativa L. extract) a new drug developed as adjunctive treatment for
the symptomatic relief of neuropathic pain in adults with multiple sclerosis
(MS). Canada becomes the first country in the world to approve Sativex, a novel
prescription pharmaceutical product derived from components of the cannabis
plant shown to have therapeutic properties. Sativex is administered via a spray
into the mouth.

Health Canada has approved Sativex with conditions, under the Notice of
Compliance with Conditions (NOC/c) policy. This authorization reflects the
promising nature of the clinical evidence which will be confirmed with further
studies. Products approved under Health Canada`s NOC/c policy, have demonstrated
promising benefit, are of high quality and possess an acceptable safety profile
based on a benefit/risk assessment for the approved use.

`Effective pain control and management are extremely important in a disease like
MS,` said Dr. Allan Gordon, Neurologist and Director of the Wasser Pain
Management Centre, Mount Sinai Hospital, Toronto, Ontario. `The approval of
Sativex in Canada reflects the urgent need for additional treatment options in
the field of neuropathic pain in MS.`

Neuropathic pain
Pain is a common symptom of MS occurring in up to 86 per cent of people with MS.
(1) Neuropathic or nerve pain can occur spontaneously or can be provoked by
touch, temperature or movement. It is estimated that 50 per cent of people with
MS suffer from chronic neuropathic pain.(2),(3),(4) The most common descriptions
of neuropathic pain are of freezing, cold or burning sensations usually of the
limbs and most often of the lower extremities.(5) Many individuals with
neuopathic pain respond inadequately to current treatment options.(6),(7)

`It`s hard to explain to someone who has never felt this type of pain. It`s like
being plugged into an electric socket all the time,` said Steve Walsh, who
suffers from MS and has lived with neuropathic pain for five years. `At times,
putting on clothes or anything touching me can be too much to take,` he added.

Data demonstrates efficacy
While there is no complete cure for MS or neuropathic pain, a double-blind
placebo controlled parallel group study demonstrated that Sativex provided
significantly greater pain relief than placebo. Sativex also significantly
reduced pain-related sleep disturbance.

Principal components
A product resulting from the pioneering research efforts of UK-based GW
Pharmaceuticals plc and marketed in Canada by Bayer HealthCare, Pharmaceuticals
Division, Sativex is the first product indicated in Canada as adjunctive
treatment for the symptomatic relief of neuropathic pain in MS.

Its principal active cannabinoid components are delta-9-tetrahydrocannabinol
(THC) and cannabidiol (CBD). The ratio of THC to CBD in Sativex is
2.7 mg : 2.5 mg per spray, ensuring a standardized dose is delivered each time
it is used.

`The approval of Sativex is good news for the Canadian MS community. People
living with MS and neuropathic pain need new options to address their pain.
Sativex will likely be welcomed by the many people with MS, whose quality of
life has been further compromised with neuropathic pain,` said Dr. William J.
McIlroy, National Medical Advisor, MS Society of Canada.

How Sativex works
Sativex is administered through a spray pump under the tongue or on the inside
of the cheek, providing reliable, self-administered pain relief. The spray
formulation allows for more flexible dosing than an oral tablet, well suited to
the variable nature of neuropathic pain experienced by people with MS.

`Because Sativex is designed for self-administration, this allows for flexible
dosing and puts the patient in control of their pain,` said Dr. Gordon. `This is
very important since pain severity varies between different patients and even in
the same patient at different times.`

Sativex and side-effects
In clinical trials, the most frequent side-effects included nausea, fatigue,
dizziness and application site reactions. Side-effects were usually mild or
moderate in severity and often resolved with down-titration or interruption of
treatment.(8)

Sativex is expected to be available through Canadian pharmacies by late Spring
2005.

Multiple sclerosis (MS) in Canada(9)
MS is a disease of the central nervous system and is the most common
neurological disease affecting young adults in Canada. Approximately 50,000
Canadian men and women have the disease and each day approximately three more
people are diagnosed. MS is most often diagnosed in people between the ages of
20 to 40 years of age.
- Ends -

[BrauchGeld]

SAN FRANCISCO & LONDON--(BUSINESS WIRE)--April 11, 2005--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. 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 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.)

[BrauchGeld]

http://www.gwpharm.com

Pipeline:
http://www.gwpharm.com/research_pipeline.asp

[crashpoet]

Thread: ENDLICH!!!! Jetzt geht es UP!!!!

[crashpoet]

[BrauchGeld]

GW Pharmaceuticals PLC
11 May 2005


For Immediate Release 11 May 2005

GW Pharmaceuticals plc
(`GW` or `the Company`)

Re: Sativex Marketing Agreement

GW and Bayer Healthcare AG announce certain amendments to their marketing
agreement for Sativex in the UK and Canada. The amendments have been made in
light of the recent regulatory approval of Sativex in Canada, and reflect the
fact that approval was granted in Canada before the UK, and not vice versa as
was envisaged at the time that the marketing agreement was entered into in May
2003.

Under the original terms of the marketing agreement, as a consequence of the
approval of Sativex in Canada last month, Bayer became obliged to make a
milestone payment to GW. Bayer has now agreed to make an immediate additional
payment to GW of £1m in further recognition of this approval.

With respect to the UK, the original terms provided, upon regulatory approval,
for Bayer to be able to elect to utilise £10m of the total payment to subscribe
for GW shares. Under the amended terms, the total payment to be received by GW
on UK approval shall be £10m and this entire amount shall be paid in the form of
a milestone payment (i.e. Bayer shall no longer be entitled to utilise any part
of the payment to subscribe for GW shares). In addition, further milestones
shall be payable to GW during the first three years following launch dependent
on sales performance.

The total milestone payments due to GW under the Bayer agreement of £32.75m
remain unchanged.

In addition, GW and Bayer have agreed a revised timeframe for their discussions
on extending Bayer`s rights to other countries. These discussions will take
place during the second half of 2005.

Dr Geoffrey Guy, Executive Chairman of GW, said, `We believe that these
amendments are a positive development for GW shareholders. While the total value
of our potential receipts under the marketing agreement remains unchanged, we
have increased our short term cash position by £1m, whilst at the same time
ensuring that the substantial UK approval payment will not be dilutive to our
shareholders. With the successful approval of Sativex in Canada as well as our
continued close collaboration in the UK, the GW-Bayer partnership remains
strong.`