GWP.L Regulatory News (GWP)

4 Jan 2006 07:00

GW Pharmaceuticals PLC04 January 2006 For Immediate Release 4 January 2006 GW Pharmaceuticals plc ("GW" or "the Company") FDA Accepts Investigational New Drug (IND) Application For Sativex(R) Sativex(R)To Enter Directly Into Phase III Cancer Pain Trials in United States GW Pharmaceuticals (AiM:GWP) today announced that the U.S. Food and DrugAdministration (FDA) has accepted its Investigational New Drug (IND) Applicationfor Sativex(R), a cannabis-derived, oro-mucosal spray composed primarily oftetrahydrocannabinol (THC) and cannabidiol (CBD), a non-psychoactivecannabinoid, for the treatment of pain in patients with advanced cancer that hasnot been adequately relieved by opioid medications. As part of this IND, the FDA has agreed that GW Pharmaceuticals may proceeddirectly into pivotal Phase III clinical trials in the United States in thisvery seriously ill patient population. This IND follows a pre-IND/end of Phase II meeting held with the FDA in June2005. The FDA has reviewed the extensive quality, safety and efficacy datagenerated by GW on Sativex in Europe. In addition, the FDA has provided writtenguidance on the U.S. Phase III trial protocol. The planned 250 patient,double-blind, randomized placebo controlled study will evaluate the effect ofSativex in relieving average daily pain, reducing the use of breakthrough opioidmedications, improving the quality of sleep and relevant aspects of quality oflife among other outcome measures. Pain is one of the common symptoms associated with cancer and each year morethan 250,000 terminal cancer patients in the USA take opioids for pain relief.(1) Approximately 75% of advanced cancer patients experience pain.(2) "A previous Phase III clinical study showed that Sativex achieved astatistically significant improvement in pain relief in terminally ill cancerpatients," says researcher, Dr. Russell K. Portenoy, Chairman of the Departmentof Pain Medicine and Palliative Care at Beth Israel Medical Center in New YorkCity. "Although opioids are highly effective analgesics, studies suggest that asmany as one-third of patients with pain due to advanced cancer do not obtainadequate relief and new treatments are needed. Cannabinoid formulations mayrepresent an important option in the future and the information obtained fromclinical trials of Sativex will be critical in defining their role." GW has completed a positive Phase III study in Europe in 177 patients withcancer pain. The trial was a multi-center double-blind, randomized,placebo-controlled parallel group study. Patients in the study had advancedcancer and were experiencing pain that was not responding adequately to strongopioid medication (e.g. morphine). In addition to study medication, all patientsremained on their existing opioid and other analgesic medication during thetrial. In this study, Sativex achieved a statistically significant improvementin comparison with placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of the study. A responder analysis showed thatapproximately 40% of patients on Sativex showed a greater than 30% improvementin their pain (p=0.024). Sativex is a pharmaceutical product standardized by both composition and dosethat is supplied in small vials as an oromucosal spray. Sativex is thought toact via cannabinoid receptors that are distributed throughout the centralnervous system and in immune cells.(3) These receptors are distributedthroughout the pain pathways of the nervous system, and their activation isknown to reduce pain in relevant pain models. "Sativex seems to be a very promising treatment option for patients whose paindoes not respond to current analgesics," said Dr. Nathaniel Katz, AssistantProfessor of Anesthesia, Tufts University School of Medicine. "The clinical datathus far suggest that many patients who have been suffering with intractablepain may gain significant benefit from the use of Sativex. I welcome GWexpanding its research program into the U.S." GW expects to carry out two pivotal Phase III trials in cancer pain in the U.S.prior to filing a U.S. regulatory submission. The U.S. development plan alsoincludes other smaller scale supporting studies. This clinical program is likelyto commence in late 2006. A U.S. regulatory submission could reasonably beexpected to occur 24-36 months thereafter. "We are very excited about the FDA's acceptance of our IND," said Dr. GeoffreyGuy, Executive Chairman, GW Pharmaceuticals. "GW believes that Sativexrepresents a first-in-class valuable new treatment option for the many advancedcancer patients in the United States whose suffering has not been adequatelymanaged by current opioid pain medications." Dr Guy added, "The acceptance by the FDA of this Phase III IND is a significantachievement for the company. It is a recognition of the technical excellence ofGW's team, the sound scientific basis for Sativex, the quality of the productand the extent of the quality, safety and efficacy data generated to date. Ithas, for some time, been GW's strategy to generate extensive data on Sativex inEurope before embarking on discussions with FDA. This strategy has now providedthe optimum outcome in allowing the Company to proceed directly into U.S. PhaseIII clinical trials, thus compressing the overall potential timelines to filinga U.S. regulatory submission. We are delighted that the FDA has accepted ourapproach." In April 2005, GW announced that Sativex had been granted regulatory approval inCanada for the symptomatic relief of neuropathic pain in multiple sclerosis. Sativex has already been subject to an extensive pharmaceutical developmentprogram, in which more than 2000 patients and subjects have been involved inclinical trials. - Ends - Enquiries: GW Pharmaceuticals plc + 44 (0)1980 557000Dr Geoffrey Guy, Executive ChairmanJustin Gover, Managing DirectorMark Rogerson, Press and PR + 44 (0)7885 638810 Weber Shandwick Square Mile + 44 (0)20 7067 0700Kevin Smith, Yvonne Alexander, Rachel Taylor MS&L New York + 1 (212) 468 4226Lolita Verny Notes to Editors: About GW Pharmaceuticals plc GW was founded in 1998 and listed on the Alternative Investment Market (AiM) ofthe London Stock Exchange in June 2001. Operating under license from the UK HomeOffice, the company is developing cannabis-derived pharmaceutical products forpatients with multiple sclerosis, spinal cord injury, rheumatoid arthritis,neuropathic pain, cancer pain and other severe medical conditions. GW maintainscontrol over all aspects of the development process: botanical research,cultivation, extraction, formulation and medication delivery. GW has assembled a team of over 100 scientists with extensive experience indeveloping both plant-based prescription pharmaceutical products and medicinescontaining controlled substances. GW is dedicated to developing treatmentoptions that alleviate pain symptoms in patients who suffer from seriousailments. This news release may contain forward-looking statements that reflect theCompany's current expectations regarding future events, including developmentand regulatory clearance of the Company's products. Forward-looking statementsinvolve risks and uncertainties. Actual events could differ materially fromthose projected herein and depend on a number of factors, including (interalia), the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion ofuncertainties related to the regulatory process, and the acceptance of Sativexand other products by consumer and medical professionals. -------------------------- References(1) University of Chicago Chronicle. "New drug promises pain relief for manyterminal cancer patients." Last accessed 21 December 2005. Available at http://chronicle.uchicago.edu/000217/drug.shtml.(2) National Cancer Institute. "Communicating About Cancer Pain." Last accessed21 December 2005. Available at http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_112905/page4(3) Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet." Lastaccessed 16 December 2005. Available at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sativex_factsheet_e.html. This information is provided by RNS The company news service from the London Stock Exchange