Regulatory Update - UK and Canada

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Dec 03, 2004

GW is today providing an update on the progress of its regulatory filings for Sativex in the UK and Canada.

UK Status

In the Interim Statement dated 21 June 2004, GW announced that it would be submitting further information intended to address the outstanding questions from the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA) during summer 2004 relating to its Sativex application.

For a medicine to be granted a product licence, it must satisfy the three criteria of quality, safety and efficacy. The outstanding questions from the MHRA related to all three sections of the application. GW proceeded to submit this further information to the MHRA within the anticipated timeframe. Furthermore, following discussion GW was advised by the MHRA to concentrate this initial application on the indication of relief of spasticity in Multiple Sclerosis (MS) patients and the application was therefore made on this basis.

The Committee on Safety of Medicines (CSM), an advisory body to the MHRA, has recently met to review the updated Sativex application for spasticity. Following this meeting, GW has today received a letter detailing the CSM’s opinion in advising the MHRA, which is as follows in respect of the three criteria:

Quality: No outstanding issues to prevent grant of product licence.

Safety: No outstanding issues to prevent grant of product licence.

Efficacy: Positive effect in spasticity seen in clinical data but clinical relevance* is uncertain. A further confirmatory study in spasticity is required which, if sufficiently positive, would enable grant of a product licence.

Notwithstanding this opinion, GW has been advised by the MHRA that the Company may elect to continue the current regulatory process based on the existing spasticity data package. In these circumstances, the next stage is to seek a hearing with the Medicines Commission, the senior advisory body to the MHRA. The Medicines Commission hearing can be expected to take place in approximately six months. GW will be pursuing this next stage which, if successful, will lead to the immediate grant of a product licence. In parallel, GW also plans to commence the further confirmatory study required by the CSM.

(*clinical relevance: i.e. how much the improvement seen means to the patient)

Canada Status

GW submitted a regulatory application for Sativex in Canada in May 2004. This application was in support of the treatment of Neuropathic Pain in patients with MS.

The Canadian regulatory authority, Health Canada, have proceeded to carry out the regulatory review swiftly and GW understands that the process is approaching completion. To date, Health Canada have not made GW aware of any issues which will prevent the grant of a product licence.

UK Background

After the initial Sativex regulatory application in March 2003, GW received questions from the MHRA in respect of 46 different issues. To date, resolution of all issues except one have been agreed with the regulators.

Both earlier this year and in 2003, GW received guidance from the MHRA that, in light of the promising data generated from its earlier clinical studies in MS spasticity, a further positive clinical study in MS spasticity would be sufficient to enable the grant of a product licence. GW was also advised that the Company’s broader clinical trials data set could be considered following the initial approval to vary the initial licence.

In June 2004, GW reported positive results from this further study in MS spasticity (GWMS0106) and duly submitted this data to the MHRA. The CSM’s recent opinion that a further study would be required for this indication is therefore contrary to the previous guidance provided to GW.

The CSM’s opinion is based on its view that the clinical relevance of the statistically significant effect seen in study GWMS0106 remained uncertain. This opinion is contrary to the views of a number of the UK’s senior experts in the treatment of MS who presented to the CSM on this matter at their recent meeting.

Professor Mike Barnes, President of the World Federation of Neuro-rehabilitation, Chairman of the Royal College of Physicians Rehabilitation Committee and Trustee of the MS Trust, said, “As a specialist in neurological rehabilitation, with long and substantial experience in treating people with MS, and an independent expert who has personally advised the CSM on the use of Sativex, I am very disappointed that the CSM has not followed my recommendation that the data fully support the approval of Sativex. My opinion is that the clinical trials show that Sativex offers sustained benefit to many patients with spasticity due to MS who are otherwise unable to find relief from their condition.”

Professor Derick Wade, Professor in Neurological Rehabilitation, University of Oxford, and clinical expert on MS for the National Institute of Clinical Excellence National Clinical Guideline on management of MS, said, “I have treated more than 60 patients in clinical trials with Sativex. We have seen improvements in spasticity, and in other symptoms, usually sustained for many months. For patients, relief of spasticity is, like relief of pain, a substantial benefit in its own right. Many of those involved in the studies had already tried all other available treatments and so I believe Sativex is a valuable treatment option for people with MS whose spasticity is not yet adequately controlled.”

Given that the CSM has no outstanding issues in respect of quality and safety and recognises that the clinical data do show a positive effect in patients, GW is disappointed that the CSM opinion would appear to take no account of patient need. In particular, study GWMS0106 showed a positive effect in patients who had failed to respond to all available treatment and therefore have no further treatment options available. Fifty percent of these patients were either bed-bound or unable to walk. The study further showed that over 40% of such patients obtain an improvement in their spasticity of greater than 30% over and above all current medication.

Immediate Next Steps With UK Spasticity Application

In the UK, GW will be proceeding to a hearing at the Medicines Commission to obtain regulatory approval for treatment of spasticity in MS patients who have failed to respond to existing treatments. The Medicines Commission hearing can be expected to take place in approximately six months. At the hearing, independent experts will be able to provide their advice to the Commission. A successful outcome would lead to a product licence being granted.

GW is also acutely aware of the need of MS patients for Sativex in the intervening period. At present, the Home Office has issued licences to GW to allow the supply of Sativex as an unlicensed medicine to patients who have participated in the Company’s clinical trials. GW plans to enter into discussions with the Home Office regarding the possible expansion of these licences so as to enable the supply of unlicensed Sativex to a broader group of patients.

Future Applications

The initial application for Sativex has concentrated on the relief of MS spasticity. This indication is just a small part of the scope of GW’s development pipeline. To date, GW’s research programme includes positive data from six Phase III trials as well as five Phase II trials supporting the effectiveness of Sativex in treating several MS symptoms, neuropathic pain and other conditions. Three further Phase III trials are due to report in the near future.

On the basis of the scope of data generated as well as the three ongoing Phase III trials, GW expects to submit a further application to the MHRA for a different indication during 2005.

Separately, GW will follow the advice of the CSM to carry out one further Phase III spasticity study which, if sufficiently positive, will ensure the grant of a product licence for this particular indication. GW aims to commence this study as soon as possible.

In addition, GW already had plans in place to initiate further Phase III trials to support the second wave of regulatory applications in indications such as neuropathic pain. These trials will continue as planned.

Dr Stephen Wright, GW’s R&D Director, said, “We are disappointed and surprised by the CSM’s advice to the MHRA which is contrary to both earlier advice we had received and to the views of leading medical experts in the field. Despite this, the UK regulatory process is ongoing. We have made substantial progress during the course of this application in resolving 45 of the 46 areas of questions and it is of great significance that there are no outstanding quality and safety issues. We now have confirmation that one further positive spasticity study would enable a product licence. Whilst following the CSM’s guidance in starting a further study, we firmly believe that the current data package is sufficient to support the efficacy of Sativex and that position of the CSM rests on a technicality. We will be proceeding to a Medicines Commission hearing on this basis which, if positive, will lead to Sativex’s approval.”

Dr Geoffrey Guy, Executive Chairman of GW, said, “It is very frustrating not only for GW but also for the UK’s 85,000 MS patients that the regulators have formed their current opinion based on an uncertainty as to clinical relevance. We believe that this issue can potentially be resolved through representations from the medical and patient community and we will be pursuing this avenue strongly. Sativex directly addresses unmet needs for MS patients and we are disappointed that these needs do not appear to be factored into the current UK regulatory position. Over the last 18 months, we have endeavoured to follow precisely the guidance of the MHRA in moving towards an approval and have faithfully relayed this guidance to the investment community.

“Despite this setback, we continue to pursue the regulatory applications for Sativex in both UK and Canada. Given that Sativex has produced positive results in every clinical trial completed, we remain firmly of the view that we have a highly valuable product which will provide substantial benefits to patients across a range of medical conditions. Although we will have to wait longer for Sativex to be launched, the Board do consider that the probability of ultimate regulatory success is as great, if not greater, now than at any time previously.”

A conference call will be held for analysts at 3:30pm today. Analysts should contact Kevin Smith at Weber Shandwick Square Mile for dial-in details. A recording of this call will be accessible on the press releases page in the investor relations section of the GW website ( later this afternoon.

- Ends -


GW Pharmaceuticals plc

(03/12/04) + 44 20 7067 0700

Dr Geoffrey Guy, Executive Chairman

(Thereafter) + 44 1980 557000

Justin Gover, Managing Director

Weber Shandwick Square Mile

+ 44 20 7067 0700

Kevin Smith

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