Porton Down, UK; 10 April 2013: GW Pharmaceuticals, the biopharmaceutical company focused on discovering, developing and commercialising novel therapeutics from its proprietary cannabinoid product platform, announced that Sativex®, its treatment for spasticity in Multiple Sclerosis, has today been rescheduled in the UK from Schedule 1 under the Misuse of Drugs Act to Schedule 4, Part 1. The move follows a recommendation to the Home Office by the Advisory Council on Misuse of Drugs (ACMD), which determined that Sativex® has a low potential for abuse and low risk of diversion.
This new, less restrictive scheduling means that Sativex® can be prescribed in the UK with no restriction on supply, recording, storage or destruction. The change confirms the distinction between Sativex® - with its evidence of quality, safety and efficacy as recognised by the Medicines and Healthcare products Regulatory Agency (MHRA) - and crude herbal cannabis, which will remain on Schedule 1 of the Act.
“This rescheduling is an important legal milestone for Sativex®, both in the UK and around the world. It provides a strong reference source for lawmakers and will help differentiate Sativex® and any future cannabinoid prescription medicines developed by GW from crude herbal cannabis,” stated Dr. Geoffrey Guy, GW’s Chairman. “Achieving a low restrictive scheduling for Sativex® was one of the fundamental goals that GW set out to achieve from inception and we are delighted that the extensive scientific data generated over the last decade has informed the UK government in making this important decision.”
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UK Legislation
In the UK, the overall legislative framework which applies to all medicines is the Medicines Act 1968 and its associated legislation - principally the Prescription Only Medicines (Human Use) order 1997, which is managed by the MHRA (Medicines and Health Products Regulatory Agency). Controlled drugs are additionally defined and governed by the Misuse of Drugs Act (MDA) 1971 and associated regulations - principally the Misuse of Drugs Regulations (MDR) 2001, which fall within the remit of the Home Office. In February 2013, the Advisory Council on Misuse of Drugs advised the UK Home Office to reschedule Sativex® in Schedule 4, Part 1.
Sativex®
Sativex® was developed by UK-based GW Pharmaceuticals plc in specific response to the Multiple Sclerosis (MS) population’s unmet need for a prescription cannabis-based medicine. Manufactured under Home Office licence at an undisclosed location in the UK it is marketed by Bayer in the UK and by Almirall in the rest of Europe. Sativex® is indicated as treatment for symptom improvement in patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Sativex® is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue) and has a flexible dosing regime, particularly appropriate given the variable nature of both spasticity and MS from patient to patient.
The definition of Sativex® adopted for the purposes of re-scheduling is: a liquid formulation -
(a) containing a botanical extract of cannabis -
(i) with a concentration of not more than 30 milligrammes of cannabidiol per millilitre, and not more than 30 milligrammes of delta-9-tetrahydrocannabinol per millilitre and
(ii) where the ratio of cannabidiol to delta-9-tetrahydrocannabinol is between 0.7 and 1.3
(b) which is dispensed through a metred dose pump as a mucosal mouth spray, and,
(c) which was approved for marketing by the Medicines and Healthcare Products Regulatory Agency on 16th June 2010.
In addition to MS spasticity, Sativex® is also being investigated as a treatment for cancer pain. A Phase III cancer pain trials program is now underway with results due in 2014. Cancer pain represents the lead indication for Sativex® in the United States.
About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 20 countries. Sativex® is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex® in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional cannabinoid product candidates, including two distinct compounds, GWP42004 and GWP42003, in Phase 2 clinical development for Type 2 diabetes and ulcerative colitis, respectively, and at least two additional programs expected to enter clinical trials in the next 12 months. For further information, please visit www.gwpharm.com
Forward-looking statements
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW’s products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission, including its most recent Form F-1. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
