GW Pharmaceuticals Announces that Sativex Receives Fast Track Designation from FDA in Cancer Pain

 

GW Pharmaceuticals Announces that Sativex Receives Fast Track Designation from FDA in Cancer Pain

28  April  2014

London, UK; 28 April 2014: GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to Sativex® for the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. Sativex is currently in Phase 3 clinical trials for this indication. FDA's Fast Track program facilitates the development of drugs intended to treat serious or life threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval. “The award of Fast Track designation for Sativex represents important recognition by the FDA of the potential of this medicine to address significant unmet needs in the treatment of cancer pain," stated Justin Gover, GW’s Chief Executive Officer. “Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications. We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn.” GW is developing Sativex in the United States in collaboration with Otsuka Pharmaceutical Co. Ltd.

About Sativex in Cancer Pain

Sativexis an investigational product composed primarily of two cannabinoids: CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol), administered as a metered dose oromucosal spray. Cancer pain represents the initial target indication for Sativexin the U.S. and Sativex is currently in a Phase 3 program for the treatment of advanced cancer pain with initial data expected around the end of 2014.  It is estimated that pain is uncontrolled with opioid treatments in approximately 420,000 people in the United States.

In addition to the development of Sativex in cancer pain, Sativexis currently approved in 25 countries (primarily in Europe) for spasticity due to Multiple Sclerosis.

About the Agreement Between GW and 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 development activities required for U.S. approval are to be wholly funded by Otsuka, and Otsuka hold exclusive rights to commercialize Sativex in the U.S.

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 25 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 a deep pipeline of additional cannabinoid product candidates, including Epidiolex which has received Orphan Drug Designation from the FDA for the treatment of Dravet and Lennox-Gastaut syndromes, severe, drug-resistant epilepsy syndromes. GW’s product pipeline also includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type‑2 diabetes, and schizophrenia. 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 statements regarding the therapeutic and commercial value of the company's compounds including Sativex® and Epidiolex®, the development and commercialization of Sativex, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval. 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®, Epidiolex®, 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. 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.

Enquiries:

GW Pharmaceuticals plc

(Today) + 44 20 3727 1000

Justin Gover, Chief Executive Officer

(Thereafter) + 44 1980 557000

Stephen Schultz, VP Investor Relations (US)

401 500 6570

 

 

FTI Consulting (Media Enquiries)

 

Ben Atwell / Simon Conway / John Dineen (UK)

+ 44 20 3727 1000

Robert Stanislaro (US)

212 850 5657

 

 

Trout Group, LLC (US investor relations)

 

Todd James / Chad Rubin

646 378 2900