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Bayer AG to market cannabis based medicine Sativex in the UK
From:
info@cannabis-med.org
Sent: Monday, May 25, 2003 9:27 AM
UK: Bayer to market cannabis based medicine Sativex in the
UK
German drugs and chemicals group Bayer AG said on 21 May
it had agreed with GW Pharmaceuticals to market a cannabis-based multiple
sclerosis and pain drug from the British company.
Bayer said in a statement it had received exclusive rights
to market the drug in the United Kingdom and had the option for a limited period
of time to negotiate rights in the European Union, as well as Canada. The United
States, however, is not part of the deal and a launch in the world's largest
pharmaceuticals market is at least two or three years away. The company said it
had paid GW a signature fee and would later pay additional fees on regulatory
approval in the United Kingdom for treatment of multiple sclerosis, neuropathic
pain and cancer pain, totalling 25 million pounds (41 million US dollars, 35
million Euros).
GW will supply the product, which is sprayed into the
mouth, and get a share of product revenues. Bayer will market the drug under the
name Sativex. GW Pharmaceuticals had submitted its medicine for approval by the
responsible agency (Medicines Control Agency) in March. UK approval of the drug
was likely by the end of the year, a spokesman of GW said.
(Sources: Reuters of 21 May 2003)
HempFarm.com Commentary to above article: Watch out
guys Bayer is "spreading the wrong message" according to some prohibitionist
zealots in the US.
Also see:
Bayer and GW Pharmaceuticals announce marketing agreement on pioneering
new cannabis-based treatment
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Leverkusen
- Bayer AG and GW Pharmaceuticals plc (GW) have entered into an
exclusive marketing agreement for GW's cannabis-based medicinal
extract product, to be marketed under the Sativex® brand
name. Bayer has obtained exclusive rights to market Sativex in the
UK. In addition, Bayer has the option for a limited period of time to negotiate the marketing rights in other countries in European
Union and selected other countries around the world. GW submitted a
product licence application for Sativex to the UK Medicines and
Healthcare Products Regulatory Agency (MHRA) in March 2003.
The
medicine has been developed by GW to provide a medically acceptable
cannabis-derived product for the treatment of the debilitating symptoms of Multiple Sclerosis (MS) and
severe neuropathic pain. The product is a whole plant
medicinal cannabis
extract containing tetranabinex (tetrahydrocannabinol - THC) and
nabidiolex (cannabidiol - CBD) as its principal components. The
medicine is administered by
means of a spray into
the mouth.
Sativex and a THC
medicine are also undergoing Phase III trials for the treatment of cancer pain. If approved, Bayer will also market these
medicines for cancer
pain.
"We are delighted
that GW has selected Bayer as its marketing partner to bring this
innovative medicine to market. Supporting medical professionals with
effective therapies for the management of MS and severe neuropathic pain is an area of largely unmet
need. I am therefore very excited that Bayer will be bringing a
product to market with the potential to make a significant
contribution in this area. Our two companies are now working closely
to prepare for market launch in the
UK. Sativex will enhance
our portfolio in the
UK extremley
well and strengthen the market position of Bayer pharmaceuticals",
said Dr. Christa Kreuzburg, Head of Europe for Bayer HealthCare's
Pharmaceuticals Division.
Dr Geoffrey Guy,
Executive Chairman of GW, said: "We are delighted to have entered
into this partnership with Bayer. Having recently submitted the
regulatory dossier for Sativex to the
UK
regulatory authorities, this announcement is a further significant
achievement for GW. It is GW's first commercial collaboration and
marks the start of a new phase in the company's history. As a
leading global pharmaceutical company, Bayer is well placed to
maximise the market opportunity for GW's product."
The financial
terms of this partnership have been established to yield equal long
term value to each partner. In addition to a share of product
revenues, GW has received a signature fee and will receive
additional fees on regulatory approval in the UK of the initial
indications of MS, neuropathic pain and cancer pain, totalling £25
million. In the event that Bayer exercise the option for countries
outside the UK, additional milestones shall be payable on a country
by country basis.
Of the £25
million milestone payments, £10 million can be drawn by GW in
advance as an interest-free working capital facility to support
ongoing preparations for market launch of Sativex. The facility can be drawn by GW at GW's
discretion until MHRA approval is obtained. On approval, Bayer has
the option to convert the facility into a milestone payment
or to convert into GW shares at an agreed premium to the share price
at the time of conversion. The facility is subject to additional
conditions if MHRA approval is not obtained by 30 September 2004.
GW is to be
responsible for commercial product supply and has entered into a
supply agreement with Bayer. GW will manage the supply of product
through a range of contract manufacturing partners, arrangements for
which are all in place.
Forward-looking statements
This news release contains forward-looking statements based on
current assumptions and forecasts made by Bayer Group management.
Various known and unknown risks, uncertainties and other factors
could lead to material differences between the actual future
results, financial situation, development or performance of the
company and the estimates given here. These factors include those
discussed in our public reports filed with the Frankfurt Stock
Exchange and with the U.S. Securities and Exchange Commission
(including our Form 20-F). The company assumes no liability whatsoever to update these
forward-looking statements
or to conform them to future events or developments. |
***Science: Heartburn New animal research shows that THC
play a role in a reflex that can result in reflux of stomach acid into the
esophagus. This reflex was significantly attenuated by THC. Thus, THC may be
beneficial in the so-called "gastro-oesophageal reflux", which is characterised
by heartburn, regurgitation of stomach acid, and inflammation of the esophagus.
(Quelle: Partosoedarso ER, et al. J Physiol 2003 May 16; [electronic publication
ahead of print])
***Science: Neuropathic pain Neuropathic cancer pain and
pain due to inflammation was induced in mice. A synthetic cannabinoid
(WIN55,212-2) attenuated tumour-evoked pain approximately 50% and was more
potent at reducing pain in the inflammatory model. In the cancer model the
cannabinoid effect was partially blocked by pre- treatment with a CB1 receptor
antagonist, in the inflammation by a CB1 and a CB2 antagonist. (Source: Kehl LJ,
et al. Pain 2003 May;103(1-2):175-86)
***Science: Neuropathic pain Demyelinating diseases such
as multiple sclerosis can be associated with painful sensory phenomena such as
tactile pain and hyperalgesia. Demyelination is the term used for a loss of
myelin, a substance in the white matter that insulates nerve endings. In a model
of demyelination a cannabinoid that binds to the cannabinoid receptor was shown
to decrease this neuropathic pain. (Source: Wallace VC, et al. J Neurosci 2003
Apr 15;23(8):3221-33

 
*Industrial-Hemp has no
psychoactive properties following definition of the European Economic Community (EEC);
THC content is less than 0.3%. In general, low THC-seed varieties without psychoactive
properties are those that have a THC content of less than 1%. (See also No-THC Hemp-seed.)
THC= Delta-9 TetraHydroCannabinol.
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