Overview
The Company
GW Pharmaceuticals was founded in 1998 and listed on AIM, a market of the London Stock Exchange, in June 2001. GW is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes. The Group's lead programme is the development of a product portfolio of cannabinoid prescription medicines, including Sativex® Oromucosal Spray, to meet patient needs in a wide range of therapeutic indications.
GW has assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. GW maintains in-house control over all aspects of the cannabinoid product development process - botanical research, extraction technology, formulation into drug delivery technologies, clinical trials and regulatory affairs. GW also holds GMP manufacturing licences for the manufacture of pharmaceutical products for both clinical trials and commercial purposes.
Sativex®
GW’s lead product, Sativex is now approved in the UK and available as a prescription medicine. It is indicated as add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (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 expected to be approved and launched in Spain in the second half of 2010. For other European countries, regulatory applications are expected to be made under the Mutual Recognition Procedure in the second half of this year. Sativex is also approved and marketed in Canada for the relief of neuropathic pain in Multiple Sclerosis (MS) and cancer pain. Each of these approvals was secured under the Notice of Compliance with Conditions (NOC/c) policy. Sativex is also in late stage development in the United States for the treatment of cancer pain.
GW has entered into three licensing agreements for Sativex – with Bayer HealthCare in the UK and Canada, with Almirall in Europe (excluding UK) and with Otsuka Pharmaceutical Co. Ltd in the United States.
Cannabinoid Research
GW occupies a world leading position in cannabinoid science and has developed an extensive international network of the most prominent scientists in the field. In mid 2007, GW’s early cannabinoid research activities were significantly expanded through the establishment of a global cannabinoid research agreement with Otsuka. Under this collaboration, GW and Otsuka are researching novel cannabinoids as potential treatments in the fields of Central Nervous System (CNS) disorders and oncology. In addition, GW has an in-house programme researching cannabinoids in the field of type 2 diabetes and related metabolic disorders. As part of this programme, GW set up in 2009 the GW Metabolic Research Laboratory at the University of Buckingham.
