Date: 2012-03-15
Type of information: Granting of a patent
Product name: Sativex®
Compound: Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)
Therapeutic area: Neurodegenerative diseases
Action mechanism: cannabinol derivative/endocannabinoid modulator. Sativex® is an endocannabinoid modulator made of two actives - THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol). As part of the human endocannabinoid system (ECS), cannabinoid receptors, CB1 and CB2 receptors are found predominantly at nerve terminals where they have a role in retrograde regulation of synaptic function. THC acts as a partial agonist at both CB1 and CB2 receptors, mimicking the effects of the endocannabinoids, which may modulate the effects of neurotransmitters (e.g. reduce effects of excitatory neurotransmitters such as glutamate).
Company: GW Pharmaceuticals (UK) Almirall (Spain)
Disease: spasticity due to multiple sclerosis
Latest news: * On January 8, 2014, the french drug agency, l’agence nationale de sécurité du médicament et des produits de santé (ANSM), has approved Sativex®. Sativex® is now approved for use in the treatment of MS spasticity in 24 countries. 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).
* On November 27, 2013, GW Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, has announced that it has received regulatory approval for Sativex® in Switzerland. A full marketing authorization has been granted by the Swissmedic authorities in the treatment of moderate to severe spasticity in multiple sclerosis patients who have not responded adequately to other anti-spasticity medications. Launch timing is dependent on completion of pricing and reimbursement procedures. Sativex will be commercialized in Switzerland by GW’s European partner, Almirall S.A. Sativex® is approved for use in the treatment of MS spasticity in 23 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden, Italy and Finland with launches currently in preparation for a further 8 European countries, as well as Australia, New Zealand and Kuwait.
* On October 21,2013, GW Pharmaceuticals has announced the successful closing of the European Mutual Recognition Procedure (MRP) in France for Sativex® oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS) and a resulting recommendation for approval by the French authorities. The next step in the regulatory process is to work with the French National Agency of Medicine and Health Products Safety (ANSM) to finalize any country-specific requirements. Following completion of this next step, it is then expected that France will issue a national marketing authorisation. Launch timing in France is dependent on completion of subsequent national pricing and reimbursement procedures. Sativex® will be commercialized in France by GW’s European partner, Almirall S.A. In the United States, GW announced in August 2013 that it had opened a Phase 3 Investigational New Drug (IND) application with the FDA to conduct a pivotal efficacy and safety clinical program to evaluate Sativex® for the treatment of MS spasticity. GW expects the U.S. Phase 3 trial to commence in 2014. Sativex is also currently in Phase 3 clinical trials as a treatment for cancer pain.
* On July 22, 2013, GW Pharmaceuticals has announced that it has submitted an application under the European Mutual Recognition Procedure (MRP) seeking to expand the marketing authorization for Sativex® into France for the treatment of spasticity due to multiple sclerosis. This new regulatory application follows a Decree signed by the French Minister of Health in June 2013, which amended national legislation in France so as to permit a prescription cannabis-based medicine, subject to approval by ANSM, the French regulatory authority. As with previous Sativex® MRP filings, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as the Reference Member State.
* On May 8, 2012, GW Pharmaceuticals and Almirall have announced the successful completion of the European Mutual Recognition Procedure (MRP) for Sativex® oromucosal spray in the treatment of spasticity. 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. The next step in the regulatory process involves separate national phases in each country to finalise local wording on product packaging and related documents and also to agree any other country-specific requirements. Following completion of the national step, each country is then expected to issue a national marketing authorisation. Launch timing in these ten new countries is dependent on national pricing and reimbursement procedures. Launches are anticipated from the end of 2012 onwards.
* On March 15, 2012, Almirall has announced the signature with GW Pharma 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).
* On February 7, 2012, Almirall 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 include: Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia. The UK is acting as reference member state in this MRP.
* Approval for Sativex® was granted in Germany on 26th May 2011, in Denmark on 8th June 2011.
* On March 22, 2011, GW Pharmaceuticals and Almirall have announced 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 initial approvals obtained in the UK and Spain during 2010, the objective of this MRP was to expand the approval of Sativex® to six additional European countries. The MRP has now closed successfully with the regulatory authorities in all six countries confirming that Sativex® meets their requirements for approval. The countries involved in the MRP and in which Sativex® is now expected to be approved are Germany, Italy, Denmark, Sweden, Austria and the Czech Republic.The next step in the regulatory process involves separate national phases in each country to finalise local wording on product packaging and related documents and also to agree any other country-specific requirements. The companies anticipate launch before the end of 2011 in Germany, Denmark and Sweden with the remaining countries expected in 2012.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
