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GW Medical Technologies, LLC Release: FDA Accepts Investigational New Drug (IND) Application For Sativex(R)


1/4/2006 11:11:36 AM

LONDON, Jan. 3 /PRNewswire-FirstCall/ -- GW Pharmaceuticals (AiM: GWP) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for Sativex(R), a cannabis- derived, oro-mucosal spray composed primarily of tetrahydrocannabinol (THC) and cannabidiol (CBD), a non-psychoactive cannabinoid, for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.

As part of this IND, the FDA has agreed that GW Pharmaceuticals may proceed directly into pivotal Phase III clinical trials in the United States in this very seriously ill patient population.

This IND follows a pre-IND/end of Phase II meeting held with the FDA in June 2005. The FDA has reviewed the extensive quality, safety and efficacy data generated by GW on Sativex(R) in Europe. In addition, the FDA has provided written guidance on the U.S. Phase III trial protocol. The planned 250 patient, double-blind, randomized placebo controlled study will evaluate the effect of Sativex(R) in relieving average daily pain, reducing the use of breakthrough opioid medications, improving the quality of sleep and relevant aspects of quality of life among other outcome measures.

Pain is one of the common symptoms associated with cancer and each year more than 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(R) achieved a statistically significant improvement in pain relief in terminally ill cancer patients," says researcher, Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City. "Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex(R) will be critical in defining their role."

GW has completed a positive Phase III study in Europe in 177 patients with cancer pain. The trial was a multi-center double-blind, randomized, placebo- controlled parallel group study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine). In addition to study medication, all patients remained on their existing opioid and other analgesic medication during the trial. In this study, Sativex(R) achieved a statistically significant improvement in 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 that approximately 40% of patients on Sativex(R) showed a greater than 30% improvement in their pain (p=0.024).

Sativex(R) is a pharmaceutical product standardized by both composition and dose that is supplied in small vials as an oromucosal spray. Sativex(R) is thought to act via cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.(3) These receptors are distributed throughout the pain pathways of the nervous system, and their activation is known to reduce pain in relevant pain models.

"Sativex(R) seems to be a very promising treatment option for patients whose pain does not respond to current analgesics," said Dr. Nathaniel Katz, Assistant Professor of Anesthesia, Tufts University School of Medicine. "The clinical data thus far suggest that many patients who have been suffering with intractable pain may gain significant benefit from the use of Sativex(R). I welcome GW expanding 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 also includes other smaller scale supporting studies. This clinical program is likely to commence in late 2006. A U.S. regulatory submission could reasonably be expected to occur 24-36 months thereafter.

"We are very excited about the FDA's acceptance of our IND," said Dr. Geoffrey Guy, Executive Chairman, GW Pharmaceuticals. "GW believes that Sativex(R) represents a first-in-class valuable new treatment option for the many advanced cancer patients in the United States whose suffering has not been adequately managed by current opioid pain medications."

Dr. Guy added, "The acceptance by the FDA of this Phase III IND is a significant achievement for the company. It is a recognition of the technical excellence of GW's team, the sound scientific basis for Sativex(R), the quality of the product and the extent of the quality, safety and efficacy data generated to date. It has, for some time, been GW's strategy to generate extensive data on Sativex(R) in Europe before embarking on discussions with FDA. This strategy has now provided the optimum outcome in allowing the Company to proceed directly into U.S. Phase III clinical trials, thus compressing the overall potential timelines to filing a U.S. regulatory submission. We are delighted that the FDA has accepted our approach."

In April 2005, GW announced that Sativex(R) had been granted regulatory approval in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis.

Sativex(R) has already been subject to an extensive pharmaceutical development program, in which more than 2000 patients and subjects have been involved in clinical trials.

About GW

GW was founded in 1998 and listed on the Alternative Investment Market (AIM) of the London Stock Exchange in June 2001. Operating under license from the UK Home Office, the company is developing cannabis-derived pharmaceutical products for patients with multiple sclerosis, spinal cord injury, rheumatoid arthritis, neuropathic pain, cancer pain and other severe medical conditions. GW maintains control 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 in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW is dedicated to developing treatment options that alleviate pain symptoms in patients who suffer from serious ailments.

Forward-looking statement

This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events, including development and regulatory clearance of the Company'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 Company'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(R) and other products by consumer and medical professionals.

For media inquires contact: MS&L, Lolita Verny 212-468-4336 Lolita.Verny@mslpr.com GW Pharmaceuticals, Mark Rogerson 011 44 7885 638810

1) University of Chicago Chronicle. "New drug promises pain relief for many terminal 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 accessed 21 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." Last accessed 16 December 2005. Available at http://www.hc-sc.gc.ca/dhp- mps/prodpharma/notices-avis/conditions/sativex_factsheet_e.html.

GW Pharmaceuticals

CONTACT: Lolita Verny, MS&L, +1-212-468-4336, Lolita.Verny@mslpr.com; orMark Rogerson, GW Pharmaceuticals, +44-7885-638810


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