In December 2004, GW announced that the Committee on Safety of Medicines (CSM), an advisory body to the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), had advised that a further clinical study in Multiple Sclerosis (MS) Spasticity would be required prior to the grant of a UK product licence for Sativex®
In December 2004, GW announced that the Committee on Safety of Medicines (CSM), an advisory body to the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), had advised that a further clinical study in Multiple Sclerosis (MS) Spasticity would be required prior to the grant of a UK product licence for Sativex®. At that time, the CSM confirmed that there were no quality or safety issues that would prevent the grant of a product licence.
GW elected to appeal against the CSM’s decision to request a further study to the Medicines Commission, the senior advisory body to the MHRA. The Medicines Commission met in mid May and received a presentation supporting the approval of Sativex by a number of the UK’s leading experts in the field. The appeal was also attended by MS patient representative organisations.
At a meeting with senior officials at the MHRA yesterday afternoon, GW was informed that the Medicines Commission has declined GW’s appeal. The Commission has determined that the evidence of efficacy of Sativex in MS Spasticity is not yet sufficiently compelling.
In December 2004, GW announced its intention to start an additional MS Spasticity study in parallel to the Medicines Commission process. This 280 patient study has now commenced and is due to report results in Spring 2006.
Meanwhile, Sativex has received regulatory approval in Canada in the treatment of Neuropathic Pain in MS. The product is due for Canadian launch imminently.
Professor Mike Barnes, President of the World Federation of Neuro-rehabilitation, Chairman of the Royal College of Physicians Rehabilitation Committee and Professor of Neurological Rehabilitation at the University of Newcastle-upon-tyne, said, “It is my view that there is excellent clinical evidence to support the regulatory approval of Sativex in the UK. I am very disappointed that the Medicines Commission did not follow the recommendation of myself and other leading experts in the treatment of MS. People with MS have considerable unmet medical needs and I am deeply saddened that the regulators do not yet feel in a position to licence this important product.”
The MHRA’s position relates solely to the indication of MS Spasticity. GW will continue to progress its research programme for the use of Sativex in a range of indications. In addition to its MS programme, GW has reported positive Phase III data in Neuropathic Pain and two further neuropathic pain trials are commencing in support of a future regulatory filing in this indication. In addition, having reported a positive Phase III Cancer Pain trial earlier this year, the Company is now planning an additional trial which will provide a registration package for this indication also.
GW remains in a strong financial position, with net cash balances of £16.2m at end of May 2005.
Dr Geoffrey Guy, Executive Chairman, said, “We are disappointed that the UK regulators consider that the efficacy data is not yet sufficiently compelling to make Sativex available to UK patients for the relief of MS Spasticity. Our view, which is shared by prominent experts in the field, is that the existing clinical data shows that Sativex provides an important new treatment option for patients with MS. We know that UK patients will share our disappointment at the decision of the regulators to delay its introduction.
“It is clear from our discussions with the regulatory authority that they recognise the promising results seen to date and they have expressed a desire to provide constructive advice to GW as to how the regulatory requirements may best be met.
“Whilst today’s news is disappointing, the fundamentals for the company remain strong. Sativex will be available on prescription to MS patients in Canada imminently. Furthermore, we have produced a wealth of positive clinical trials data, including seven Phase III trials and have a range of further trials underway. GW also retains its world leading position in cannabinoid science. Today’s setback will only serve to reinforce our determination to bring this important and innovative new medicine to the UK market.”
GW Pharmaceuticals will provide a further update when it announces interim results on the 20 June, 2005.
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GW Pharmaceuticals pl: (12/12/05) + 44 20 7067 0700
Dr Geoffrey Guy, Executive Chairman: (Thereafter) + 44 1980 557000
Justin Gover, Managing Director
Weber Shandwick SquareMile: + 44 20 7067 0700
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events, including the clinical 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 clinical studies, including with respect to Sativex and the Company's other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.