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IACM-Bulletin of 25 December 2005

Spain/UK: Agreement for the marketing of Sativex in EURope

GW Pharmaceuticals and Almirall Prodesfarma announced on 12 December that they have entered into an exclusive agreement for Almirall to market Sativex in EURope (excluding the UK). Sativex is a cannabis extract produced by the British company GW Pharmaceuticals. Almirall is Spain’s largest pharmaceutical company and one of EURope’s leading private pharmaceutical companies. It is headquartered in Barcelona and is currently present in around 100 countries worldwide. It has subsidiary operations in several EURopean markets, including France, Germany, Italy, Portugal and Belgium.

Under the terms of the agreement, GW will benefit from a 12 million British Pounds signature fee. In addition, further payments are payable on the successful completion of each of the ongoing Phase III trials, as well as on regulatory approvals and in relation to achievement of sales targets. Including the signature fee, the amounts payable under the contract may total up to 46 million British Pounds. Sativex is in Phase III trials for the treatment of Multiple Sclerosis symptoms (neuropathic pain and spasticity), neuropathic pain and cancer pain. In addition to these three indications, Almirall and GW expect to collaborate on the development of Sativex in other indications.

The licensed territory includes the members of the EURopean Union (excluding the UK), EU accession countries as well as Switzerland, Norway and Turkey. In the UK, Sativex is already licensed to Bayer HealthCare.

(Source: Press release of GW Pharmaceuticals of 12 December 2005)

Germany: Petition Committee of the German Bundestag supports the meeting of costs of a treatment with THC (dronabinol) by the health insurances

In a decision of 14 December the Petition Committee of the German Bundestag supports the petition of a pain patient who profits from THC (dronabinol) but whose health insurance since 2001 refuses to meet the costs of the treatment. Since 1985 Mrs Ute Koehler from Thuringia suffers from severe pain following a radiotherapy in the course of her cancer treatment. Only the prescription of dronabinol by a pain therapist in 1998 resulted in a significant reduction of her ailment. Notwithstanding, the responsible health insurance refused to meet the costs of the treatment and even claimed a repayment of the previous treatment costs.

The Federal Health Ministry said in a statement to the Petition Committee that meeting of the costs of dronabinol would depend on a recommendation by the Joint Federal Committee of Physicians and Health Insurances. The ministry had asked the Joint Federal Committee again to start a procedure for the evaluation of dronabinol-containing receipts. It had also pointed out that as the supervising authority the ministry would be authorized "to enact guidelines instead of the Joint Federal Committee if the maintenance of the health care requires such action and self-administration does not decide on a necessary guideline itself."

The Petition Committee writes in its decision: "It is irresponsible to abandon the cancer patient to her fate and let her pay the expensive medical drugs herself that only allow her to live a humane life." The Federal Health Ministry was asked "to tap all possibilities to find a regulation for all patients suffering from pain."

(Source: Decision of the Petition Committee of the German Bundestag of 14 December 2005, file number: Pet 2-15-16-8271-008724a)

Germany: Federal Constitutional Court decides that health insurances have to meet the costs of a new treatment if no therapeutic alternatives are available in life-threatening illness

In a ruling of 6 December (file number: 1 BvR 347/98), which was made public on 16 December, the Federal Constitutional Court decided in favour of a constitutional complaint of a patient. In his complaint the plaintiff who is suffering from a life-threatening illness demanded his health insurance to meet the costs of a non-approved treatment.

It would not be in accordance with the general freedom of action guaranteed by the Constitution, the principles of the welfare state and the base right for life, to exclude a health insured person, for whose life-threatening or usually fatal disease no generally accepted treatment that meet the medical standards is available, from the reimbursement of a treatment chosen by him and applied by a physician, if there is not too far a prospect of cure or positive influence of the disease process.

If this ruling has any consequences on the obligation of health insurances to meet the costs of a therapy with dronabinol, at least in some cases, cannot be foreseen yet. A difference to the actual case is the availability of alternative treatment options in most of the indications, in which dronabinol is used.

(Source: Press release of the Federal Constitutional Court of 16 December 2005)

News in brief

Czech Republic: Legalization of medical use
The government plans to make cannabis-based medicines available for medical use. So far, the substances from cannabis, mainly its major active substance THC, can be applied in research only on the basis of a permit issued by the Health Ministry. Theoretically, they can be used in a special medical treatment in selected cases, but the ministry said that no one has been treated with cannabis extracts in the Czech Republic yet. "With regard to the worldwide rising interest in a possible medical use of hemp, we consider it beneficial to list cannabis among the narcotics that can be used for therapeutic purposes," Vaclav Sebor from the Health Ministry's press section told the newspaper Lidove noviny. (Source: Prague Daily Monitor of 12 December 2005)

UK: Sativex
The death of a 70-year-old woman who took part in a trial with Sativex caused some media interest with articles in The Guardian and The Times, among others. An inquest has taken place in December 2005 on this issue. Mrs. Rene Anderson died in March 2004 and took part in a Sativex clinical trial over a 3 week period during October 2003. During the trial she developed psychotic symptoms that were not controlled. After 10 weeks in hospital she developed physical problems, including pneumonia and kidney failure. In his verdict at the end of the inquest, the Coroner stated that "on the balance of probabilities, an idiosyncratic reaction to a trial drug (either alone or in combination with other medications) was at least a significant contributory factor to the initiation of this illness." (Sources: The Guardian of 12 December 2005, press release of GW Pharmaceuticals of 16 December 2005)

Germany: Cannabis and driving
Driving with THC in the blood is not necessarily a misdemeanour or even a criminal offence according to a ruling of the Appelate Court of Koblenz. While the law prohibits driving under the influence of a drug once the substance is detected in the blood, however, since meanwhile smallest amounts are detectable, it has to be explicitly ascertained that the driving abilities of the subject were influenced (file number: 1 Ss 189/05). (Source: Sueddeutsche Zeitung of 14 December 2005)

USA: California
One of the biggest raids against Californian cannabis dispensaries took place in San Diego county on 12 December. Federal agents searched 13 dispensaries. Additional discussion was raised by the fact that the raids seemed to be ordered by a state judge, not a judge of a federal court. Law enforcement officials said the warrants followed investigations by undercover agents who purchased cannabis without the paperwork required for medical use under the Californian medical cannabis law. Although no charges have been filed, dispensary operators fear arrests. They worry about where patients can get cannabis now, and what the government will do with patient records it seized. (Sources: San Diego Union Tribune of 13 and 19 December 2005)

UK: New report
A new report by the Royal College of Physicians published in December 2005 states that medicines based on cannabis and its derivatives have the potential to treat a range of symptoms but that more clinical research is needed. "There is some evidence for relief of spasticity and neuropathic pain and for improvement in sleep," the report says. "There is evidence that exposure to cannabis in adolescence is associated with subsequent psychotic illness. However, the patient population that might use cannabis as a medicine is generally older than those at risk of cannabis-induced psychosis." The summary and a patient information of the 44-page-report "Cannabis and cannabis-based medicines" is available online at: www.rcplondon.ac.uk/pubs/books/cannabis/.

Science: Brain injury
In a phase III clinical trial the synthetic cannabinoid dexanabinol was not effective in reducing the consequences of severe traumatic brain injury. 861 patients admitted to 86 specialist centres from 15 countries were included in this placebo-controlled study. Patients were randomised to receive a single intravenous 150 mg dose of dexanabinol or placebo within 6 h of injury. Outcome between the two groups did not differ 6 months after the injury. (Source: Maas AI, et al. Lancet Neurol 2006;5(1):38-45)

Science: Depression
Blockade of the deactivation of the endocannabinoid anandamide resulted in antidepressant-like effects in a mouse and a rat model of depression. Researchers used an inhibitor of the enzyme fatty-acid amide hydrolase, which increases the breakdown of anandamide, thus increasing the concentration of this endocannabinoid. They concluded that these "findings support a role for anandamide in mood regulation and point to fatty-acid amide hydrolase as a previously uncharacterized target for antidepressant drugs." (Source: Gobbi G, et al. Proc Natl Acad Sci U S A 2005;102(51):18620-5)

Science: Cancer
A synthetic analogue of anandamide, called Met-F-anandamide, was effective in reducing invasion into the surrounding tissues and metastatic spreading of breast cancer in animal tests. These effects were mediated by CB1 receptors. Researchers propose that the activation of CB1 receptors "might represent a novel therapeutic strategy to slow down the growth of breast carcinoma and to inhibit its metastatic diffusion." (Source: Grimaldi C, et al. Exp Cell Res 2006;312(4):363-73)

Science: Cancer
In this study cells of a certain blood cell cancer, called mantle cell lymphoma, with increased concentrations of CB1 and CB2 receptors responded to a treatment with the synthetic cannabinoid Win-55,212-2. This cannabinoid that acts similar to THC resulted in a decreased viability of these cancer cells in cell studies. Cancer cells of the same type that lacked cannabinoid receptors did not respond to this treatment. (Source: Flygare J, et al. FEBS Lett 2005;579(30):6885-9)

Science: Alzheimer's disease
Researchers investigated the effects of a synthetic cannabinoid that binds specifically to the CB2 receptor on certain immune cells of the brain called microglial cells. These cells are involved in a number of neurodegenerative disorders, including Alzheimer's disease and multiple sclerosis. The cannabinoid reduced several effects induced by microglial cells that usually result in nerve cell damage. (Source: Ehrhart J, et al. J Neuroinflammation 2005;2(1):29)

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