Porton Down, UK; 30 June 2011: GW Pharmaceuticals plc (AIM: GWP) today announced the initiation of a second Phase III Sativex® clinical trial in the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. This indication represents the initial target indication for Sativex® in the United States.
The newly-commenced study is part of a Phase III programme being performed in conjunction with GW’s U.S. licensing partner for Sativex®, Otsuka Pharmaceutical Co. Ltd. The programme, fully funded by Otsuka, includes at least two Phase III randomised placebo-controlled multi-centre multinational trials as well as a long term extension study. The first study commenced in December 2010.
This Phase III trial employs the same study design and endpoints as the first and is intended to include approximately 380 patients. The efficacy and safety of Sativex® versus placebo is evaluated over a 5 week treatment period.
The primary efficacy measure of the Phase III trials is a patient assessment of pain using a 0-10 Numeric Rating Scale (NRS), and the primary analysis is the “continuous response analysis of percent improvement from baseline” (an analysis of percent improvement in pain across the spectrum of response levels). This analysis has yielded statistically significant results in both the Phase IIa and IIb trials and has been the key efficacy parameter discussed in the product labeling of several recently approved medicines in the US for pain. The dose range employed in the studies is 3 – 10 sprays per day.
The Phase III programme is expected to include patients in Europe, North America, Latin America and Asia. Recruitment for the two Phase III studies is initially taking place at sites in Europe. Professor Marie Fallon, Professor of Palliative Care, University of Edinburgh, is principal investigator of the first study. The principal investigator of the second study is Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City.
Studies suggest that more than one-third of patients with cancer, and more than three-quarters of those with advanced disease, have chronic pain. Large surveys indicate that optimal opioid therapy does not yield sufficient relief in a substantial proportion of these patients.
Dr. Stephen Wright, GW’s R&D Director, said, “We are pleased to have commenced this second Phase III study in line with our previous expectations. The development of Sativex®for cancer pain represents a major opportunity and we look forward to continuing to work closely with Otsuka on this comprehensive Phase III programme for Sativex®in this important indication.”
Sativex®is approved in the UK, Spain, Germany, Denmark, Czech Republic, Canada and New Zealand as a treatment for Multiple Sclerosis (MS) spasticity. Further approvals and launches of Sativex®in this MS indication are expected in Europe and other selected markets. Cancer pain represents the initial target indication for Sativex®in the U.S. It is intended that the Phase III cancer pain data will also be used by GW for future regulatory applications in this indication in Europe and around the world.
Sativex®is licensed to Otsuka in the US, Almirall S.A. in Europe (ex-UK), Bayer Healthcare in UK and Canada, and Novartis Pharma AG in Asia (ex-China/Japan), Middle-East and Africa.
GW Pharmaceuticals plc Today: +44 20 7831 3113
Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000
Justin Gover, Managing Director
Mark Rogerson, Press and PR Tel: + 44 7885 638810
Financial Dynamics Tel: +44 20 7831 3113
Ben Atwell, John Dineen
Notes to Editors
Sativex®is an investigational new product composed primarily of two cannabinoids: CBD (cannabidiol,) and THC (delta 9 tetrahydrocannabinol). Sativex®is administered as a metered dose oro-mucosal spray each 100µL spray contains 2.7mg THC and 2.5mg CBD. The Sativex®formulation is standardized by both composition and dose and is supplied in small spray vials. The components of Sativex®have been shown to bind to cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.
Cancer pain represents the initial target indication for Sativex®in the US. Sativex®is approved in the UK, Spain, Germany, Denmark, Czech Republic, Canada and New Zealand as a treatment for Multiple Sclerosis spasticity.
In February 2007, GW and Otsuka entered into a major long term strategic alliance. The relationship commenced with the signing of an exclusive license agreement to develop and market Sativex®, GW’s lead product, in the US. In July 2007, GW and Otsuka signed a global research collaboration for the study of cannabinoids in the field of Central Nervous System (CNS) and oncology to research, develop and commercialize a range of candidate cannabinoid products.
About Otsuka Pharmaceutical Co., Ltd
Founded in 1964, Otsuka Pharmaceutical Co.,Ltd. is a global healthcare company with the corporate philosophy 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases, and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 23 countries and regions around the world, with consolidated sales of ¥1,090.2 billion for fiscal year 2010. For more information, visitwww.otsuka.co.jp/en
GW was founded in 1998 and listed on the AIM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field. For further information, please visitwww.gwpharm.com
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.