Industry News

CCIC memorandum on safety of FAAH inhibitors and cannabis research

29 January 2016

The recent news regarding the mortality of a patient in a phase I trial of a novel inhibitor of the endocannabinoid enzyme FAAH in France by the Portuguese company, Bial, has created considerable concern, in the public media as well as among scientists and ethics boards, about the safety of cannabis research more broadly. It is important to note that the compound that was being tested was not derived from the cannabis plant, and is chemically and pharmacologically distinct from all known plant-derived cannabinoids.

Clinical trials of structurally different FAAH inhibitors have been explored by several companies (Pfizer, Sanofi, Merck, Johnson & Johnson) prior to this recent episode, without known serious adverse effects. Each of these FAAH inhibitors was found to be safe in humans. Therefore it is currently inexplicable why a drug working only on this mechanism (FAAH inhibition) would have such a serious reaction. The CCIC and its members are concerned about the safety of patients and research subjects, and urges the company and the relevant health authorities to explain quickly and satisfactorily to the public and scientific community how and why this event occurred.

While all studies of novel synthetic drugs must be carefully and systematically evaluated for safety, especially those being used for the first time in humans, the CCIC does not believe that this event should prevent clinical research on naturally occurring, plant-derived cannabinoids from continuing. The safety of herbal cannabis in medical use has been studied and the results reported in peer-reviewed publications; research is ongoing in many jurisdictions. Establishing and regulating the quality of herbal cannabis products used in therapy and research is crucial, and is already the ethical standard for all properly managed clinical trials and studies. While this recent tragedy reinforces the need for vigilance, research regarding cannabis and cannabinoids should go on.

Newsfeed of the Canadian Medical Cannabis Industry Association

Access news from the Canadian Medical Cannabis Industry Association at: http://www.cmcia.ca/news/

New data reinforce the efficacy and safety profile of Sativex® in Multiple Sclerosis Spasticity

02/10/2013

  • Results of a new long-term, placebo-controlled trial support sustained efficacy of Sativex (THC:CBD oromucosal spray) without cognition or mood impairment
  • New study data also shows that Sativex does not cause impairment of motor vehicle driving ability
  • Sativex’s real world tolerability has now been demonstrated from registries in Germany, Spain and UK with >800 patients

Copenhagen, Denmark, 2nd October 2013: Almirall S.A. (ALM) today announces the latest evidence with Sativex® (THC:CBD spray) from new MS spasticity studies (clinical trial data, observational study data and registries data collection). These data, presented today at the 29thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, show that Sativex®effectiveness is maintained long term with no additional safety concerns identified in clinical practice.

Two-thirds of the more than 2,000 patients with MS surveyed in the recent Spanish “6E” study reported a certain degree of spasticity, being moderate or severe in 40% of them[i].

Read the full press release at: http://www.almirall.com/webcorp2/cda/comunicacion_detalle_noticia.jsp?id=2544&langSuscripcion=3

Prairie Plant Systems Inc. & CanniMed Ltd. Awarded First Two Medical Marijuana Licenses by Health Canada

SASKATOON, Sept. 23, 2013 /CNW/ - For Canadians suffering from chronic and terminal illnesses including severe pain, chronic inflammation due to arthritis or the nausea associated with chemotherapy, medical marijuana has become a well-recognized option for patients and doctors to try when conventional medicine just isn't enough.

Today, Health Canada licensed the first two companies under the new Marihuana for Medical Purposes Regulations - Prairie Plant Systems Inc. and CanniMed Ltd.

"As the sole supplier to Health Canada for the last 13 years, patients and physicians have come to trust the safety and efficacy of the Prairie Plant Systems pharmaceutical-grade cannabis," said Brent Zettl, CEO, Prairie Plant Systems. "We are very pleased to have been awarded the first two licenses under the new medical marijuana regulations."

In addition to receiving a license for Prairie Plant Systems, today marks the launch of CanniMed Ltd., a subsidiary to Prairie Plant Systems, which will be the distribution and support hub for patients and physicians, as well as the brand name of the three pharmaceutical-grade cannabis products that will be made available as soon as physically possible - CanniMed® 17.1, CanniMed® 12.0 and CanniMed® 9.9.

Read the full press release at: http://www.newswire.ca/en/story/1229547/prairie-plant-systems-inc-cannimed-ltd-awarded-first-two-medical-marijuana-licenses-by-health-canada

Sativex® starts a third Phase III clinical trial in cancer pain

Barcelona, Spain, 22nd May 2012: Almirall, S.A. (ALM:MC) is pleased to note the announcement by GW Pharmaceuticals plc (AIM:GWP) on the start of a third Phase III clinical trial of Sativex® in cancer pain in patients who experience inadequate analgesia during optimized chronic opioid therapy. Full text of the announcement from GW Pharmaceuticals plc follows: THIRD PHASE III SATIVEX®CANCER PAIN TRIAL COMMENCES Porton Down, UK; 22 May 2012: GW Pharmaceuticals plc (AIM: GWP) today announced the initiation of a third Phase III Sativex®clinical trial in the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. GW’s cancer pain clinical programme is being wholly funded by Otsuka Pharmaceutical Co. Ltd, which has licensed the US commercialisation rights to this product. The trials are designed to obtain approval in this indication from the Food & Drug Admi...

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Sativex® Mutual Recognition Procedure Closes with Recommendation for Approval in Ten European Countries

08/05/2012: Almirall website

•Sativex® is already available in the UK, Spain, Germany and Denmark. Launches currently in preparation in Italy, Sweden, Austria and Czech Republic

•Recommendation for approval now received in Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia. Launches expectedfrom the end of 2012 onwards

Barcelona, Spain; Porton Down, UK; 8th May 2012: GW Pharmaceuticals plc (AIM:GWP) and Almirall S.A. (ALM) today announce the successful completion of the European Mutual Recognition Procedure (MRP) for Sativex® oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS).

Following previous positive regulatory submissions in the UK, Spain, Germany, Italy, Denmark Sweden, Austria, Czech Republic, a MRP application was made to expand the availability of Sativex®to ten additional European countries. The MRP has now closed successfully with regulatory authorities in all ten countries confirming that Sativex®meets their requirements for approval. The countries involved in the MRP and in which Sativex® is expected to be approved are: Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.

For more information please read the full press release on the Almirall website.

Almirall supports European post-graduate clinical research examining the efficacy of Sativex® on gait parameters and will the treatment’s effect on fatigue and depression

The first winning project is an open prospective study proposed by Dr. Thorsten Schultheiß, member of the Neurology Department at Dresden University Hospital, Germany. It focuses on healthcare and healtheconomic aspects in the treatment of MSS patients with Sativex®, (the endocannabinoid system modulator recently approved). Specifically, the project will examine the efficacy of Sativex® on gait parameters and will also evaluate the treatment’s effect on fatigue and depression.

Grants are to promote post-graduate clinical research projects in the field of multiple sclerosis spasticity (MSS)

Winning projects will examine the effectiveness of physiotherapy via videoconference for MSS patients and evaluate the efficacy of a new endocannabinoid modulator medicine on gait parameters, fatigue and health resources.

Results are expected to be published by Q2 2013 Barcelona, 29th February 2012: During its offical awards ceremony at company headquarters in Barcelona, Almirall S.A. (ALM.MC) announced its MS Spasticity Research Grants for 2012 had been awarded to Dr. Thorsten Schultheiß from Germany and Mrs. María Carmen Molina Díaz from Spain.

Read More on the Almirall website.

Almirall extends Sativex® marketing rights to Mexico

Sativex®is marketed by Almirall in several European countries The medicine is undergoing a second wave of approvals in Europe through Mutual Recognition Procedure Sativex® is currently in phase III for oncological pain Barcelona, 15 march 2012.- Almirall, S.A. (“Almirall”) announces the signature with GW Pharma Ltd. ("GW") of an amendment to their existing agreement for Sativex®. As part of the amendment, Almirall has been granted rights to market Sativex® in Mexico. Under the terms of the original licence agreement signed in December 2005, Almirall was granted exclusive rights to market Sativex® in Europe (excluding the UK). Almirall has now been granted exclusive rights to commercialise Sativex® in Mexico, a country in which Almirall has had an affiliate for more than a decade. Luciano Conde, Chief Operating Officer at Almirall, said “We have be...

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Sativex® starts a new wave of regulatory submissions in Europe.

7 February, 2012, Almirall
Sativex® starts a new wave of regulatory submissions in Europe

  • Countries include Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia
  • Sativex® is a medicine indicated for the treatment of spasticity in patients with Multiple Sclerosis (MS), who have not responded to other anti-spasticity treatments
  • Almirall launched Sativex®in Spain, Germany and Denmark in 2011

Barcelona, 7th February 2012: Almirall S.A. (ALM.MC) today announced the start of a second wave of regulatory submissions for Sativex® in Europe. The list of countries submitted to the Health Authorities by GW Pharmaceuticals, under a Mutual Recognition Procedure (MRP) include: Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia. The UK is acting as reference member state in this MRP.

Response from Health Authorities is expected in the first half of 2012 and, subsequently, approval processes will continue in each country separately, according to local regulatory requirements.

"We are excited by this opportunity of broadening the geographical accessibility of the unique benefits of Sativex® alleviating symptoms of spasticity in patients with MS",says Bertil Lindmark, Chief Scientific Officer at Almirall.

Sativex® offers a new therapeutic option to patients with spasticity symptoms due to MS who have previously failed to respond adequately to other anti-spasticity medication, andit is currently available in Denmark, Germany, Spain, UK, Canada and New Zealand. Additionally, four new countries are expected to get marketing approval this year: Austria, Sweden, Italy and Czech Republic.Sativex® is administered as an oromucosal spray (either onto the inside of the cheek or under the tongue), which provides optimal delivery of the active ingredients and allows for dose flexibility thus enabling each individual patient to manage the variable nature of their spasticity.

Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

For more information visit:
http://www.almirall.com/webcorp2/cda/comunicacion_detalle_noticia.jsp?id=1614

New UK Study - Cannabinoids in Huntingtons Disease.

27 November, 2009, MEDA Pharmaceuticals, Bishop Stortford, UK:
MEDA Pharmaceuticals announces today that the Journal of Movement Disorders has published the results of a study completed in the United Kingdom, by investigators at Birmingham and Solihull Mental Health NHS Foundation Trust in Birmingham. The authors reported that the licensed synthetic cannabinoid Nabilone is well tolerated and provided improvement in some of the neuropsychiatric symptoms associated with Huntington’s disease (HD). Experts estimate that at least one in every 10,000 persons—nearly 6,000 in the UK—have Huntington's disease, an inherited chronic neurodegenerative disorder.
Click here to download the full press release.

GW receives commercial manufacturing licence for sativex®

Porton Down, UK, 16 July 2009: GW Pharmaceuticals plc (GWP:AIM) today announces that it has passed a Good Manufacturing Practice (GMP) inspection by the UK regulatory authority of its new in-house commercial manufacturing facility for Sativex®, enabling the facility to act as the primary manufacturing site for the anticipated European commercial launch of Sativex.
For the full article please click here or visit www.gwpharm.com

GW Files Sativex® Regulatory Submission

PORTON DOWN, UK, 20 May, 2009: GW Pharmaceuticals plc (GWP:AIM) today announces that it has filed a regulatory submission for Sativex® for the treatment of spasticity due to Multiple Sclerosis. This submission follows the recent announcement of a positive Phase III trial in this indication.
For the full article please click here or visit www.gwpharm.com.

Cannasat and IntelGenx Announce Positive Phase 1(b) Results Improved buccal tablet outperforms oral dronabinol

TORONTO, 14 April, 2009: Cannasat Therapeutics Inc. (“Cannasat”) (TSX-V: CTH), and its development partner IntelGenx Corp. (TSX-V: IGX and OTCBB: IGXT) ("IntelGenx"), today announced positive results for the Phase 1(b) clinical trial of Relivar, the first buccal dronabinol drug delivery product, which was developed using IntelGenx’ proprietary AdVersa buccal delivery technology. Buccal delivery allows for drug absorption from the mouth directly into the bloodstream as opposed to the intestinal tract absorption seen with oral tablet technologies.
For the full article please click here or visit www.cannasat.com.

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