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

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


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*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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