GW Pharmaceuticals plc Opens an Investigational New Drug Application (IND) in the United States for a Sativex® Phase 3 Clinical Program as a Treatment for Spasticity Due to Multiple Sclerosis

LONDON, Aug. 14, 2013 /PRNewswire/ -- GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW") announced today that it has opened a Phase 3 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical program to evaluate Sativex® for the treatment of spasticity due to Multiple Sclerosis (MS). Sativex is currently approved in 22 countries outside the U.S. as a treatment for MS spasticity.

The proposed U.S. Phase 3 program will be conducted under the agreement with GW's licensing partner for Sativex®, Otsuka Pharmaceutical Co. Ltd. Under the terms of GW's agreement with Otsuka, Otsuka is responsible for wholly funding the MS Phase 3 clinical program, as is the case with the current Phase 3 cancer pain program. 

As part of its MS spasticity IND application, GW requested feedback from the FDA on key features of the proposed single Phase 3 trial protocol. GW expects to work with the FDA over the coming months to incorporate FDA feedback and to finalize the protocol design, which may include a request for Special Protocol Assessment (SPA). GW expects the Phase 3 trial to commence in 2014.

Cancer pain remains the initial target indication for Sativex in the U.S. and it is intended that MS spasticity would represent a future second indication for the U.S. market. GW and Otsuka are currently undertaking a Phase 3 clinical trial program for Sativex in cancer pain and results from two pivotal Phase 3 trials are expected in 2014.

"With results from our U.S. Phase 3 program in cancer pain due next year, this new Phase 3 IND provides us with the opportunity to broaden the future U.S. market potential for Sativex to include MS spasticity. As such, this new IND represents an important extension of GW's and Otsuka's ambitions for Sativex in the U.S.," stated Justin Gover, Chief Executive Officer of GW. "We now look forward to working with the FDA to gain agreement on the required program to enable a future filing of an NDA for the MS indication."

Notes to Editors

About Sativex

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 100 microliter 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 U.S. A Phase 3 clinical trials program is currently underway to evaluate Sativex to treat persistent pain in patients with advanced cancer who experience inadequate pain relief from optimized chronic opioid therapy. Results from two pivotal Phase 3 cancer pain trials are expected in 2014.

Outside the U.S, Sativex is approved in 22 countries as a treatment for Multiple Sclerosis spasticity.

About GW-Otsuka

In February 2007, GW and Otsuka entered into an exclusive license agreement to develop and market Sativex in the U.S. Under the terms of this agreement, the costs of pre-clinical and clinical required for U.S. approval are to be wholly funded by Otsuka.

About MS

Multiple sclerosis (MS) is a degenerative neurological condition, which is associated with a wide range of distressing and disabling signs and symptoms. MS is the most common disabling disease of the CNS affecting young adults and is usually diagnosed between the ages of 20 and 40 years.  MS is twice as common in women than in men.  It is estimated that greater than 400,000 people in the United States have MS¹.

About spasticity

Spasticity is a common symptom associated with MS² and is a major contributor to disability.³ It is caused by damage to the nerves in the central nervous system which carry messages instructing muscles how to move resulting in an involuntary muscle overactivity.⁴

In a survey, 84% of people with MS reported symptoms of spasticity.⁵ Moderate, severe or total spasticity is reported in 34% of individuals.⁵ Symptoms include loss of mobility, painful spasms, stiffness and / or weakness of muscles.⁴ As a consequence an individual may have difficulty in walking, picking up objects, washing, dressing and other everyday activities involving movement. In addition to causing a great deal of distress to the person with MS, mood, self-image and motivation can also be affected.

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 22 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 Phase 1 and Phase 2 clinical trials in the next 12 months. For further information, please visit www.gwpharm.com.

1. World Health Organization / MS International Federation, Atlas 2008
2. Beard S, et al. Health Technol Assess 2003;7(40)
3. Multiple Sclerosis Trust. Spasticity and Spasms factsheet. November 2009
4. Rizzo MA, et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Multiple Sclerosis 2004;10:589/595
5. Multiple Sclerosis International Federation. Spasticity in MS. MS in focus. Issue 12. 2008. Available at http://www.msif.org/docs/MSinFocusIssue12EN.pdf

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding our clinical goals, the IND application, our plans for a clinical trial, the proposed MS indication, the timing of the clinical program, the ability to initiate and complete trials at the referenced times, the ability to conduct clinical trials sufficient to achieve positive completion, the uncertainty of the FDA approval process, and the therapeutic and commercial value of the company's compounds. GW's proposed trial protocols may not be approved in a timely fashion, if at all, and the FDA may require changes to our application that could prove time consuming and costly and may lead to a decision not to proceed. To the degree we are able to conduct clinical trials, we may have difficulty in enrolling candidates for testing and we may not be able to achieve the desired results. 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 the prospectus related to the NASDAQ offering filed by GW with the SEC on May 1, 2013. 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.

SOURCE GW Pharmaceuticals plc