Porton Down, UK, 5 September 2006 - GW Pharmaceuticals plc (AIM: GWP) (“GW” or “the Company”) today announces that it has filed a regulatory submission in selected European countries for Sativex®, its cannabinoid spray medicine. The filing is for the symptomatic relief of spasticity in people with multiple sclerosis (MS), a patient group with a significant unmet medical need.
To listen to the conference call that took place at 09:00 on 5th September 2006, hosted by GW, please download the audio file.
The filing has been made under the “decentralised procedure” in the UK, Spain, Denmark and the Netherlands. Under this procedure, the UK is acting as Reference Member State and will consult with the three other countries. If successful, a filing under the decentralised procedure would lead to the simultaneous approval of Sativex in these countries for the MS spasticity indication.
Upon approval, Sativex will be marketed in the UK by Bayer HealthCare and in the rest of Europe by Almirall.
Commenting on today’s announcement, Dr Stephen Wright, GW’s R&D Director, said:
“We now have a sizeable body of positive clinical data to support the efficacy and safety of Sativex in MS spasticity. This is a complex data package and we have therefore reviewed the complete dossier with our marketing partners and discussed it in detail with a number of European regulators. These meetings have provided constructive and positive feedback. The conclusion of GW and its marketing partners, taking into account the views of the regulators, as well as the unmet needs of this target patient group, is that this body of data warrants serious regulatory evaluation.”
Dr Geoffrey Guy, Executive Chairman of GW, added:
“This filing is one element of a broad-based regulatory strategy for Sativex, which is designed to maximise the opportunities for Sativex as well as to manage the risks associated with its development. Beyond the filing today in MS spasticity, the Phase III clinical trials programme continues and will provide further sets of clinical data to support additional regulatory filings in separate indications. This approach is aimed at creating several independent opportunities to obtain regulatory approvals for Sativex in the coming years.”
There will be a conference call for analysts today at 9.00am. Please contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. A recording of this call will be accessible on the press releases page in the investor relations section of the GW website (www.gwpharm.com) later today.
GW Pharmaceuticals plc
Today: +44 (0)20 7831 3113
Dr Geoffrey Guy , Chairman
Thereafter: + 44 (0)1980 557000
Justin Gover , Managing Director
Mark Rogerson , Press and PR
Tel: + 44 (0)7885 638810
Tel: +44 (0)20 7831 3113
David Yates, Ben Atwell
Tel: +44 (0) 1635 563607
Weber Shandwick Healthcare
Natalie Murphy, Brian Tjugum
Tel: +44 (0) 20 7067 0000
Notes to Editors
Background to the submission
The current submission is supported by a body of clinical data in approximately 700 patients with MS spasticity, and includes two pivotal Phase III trials as well as two supportive trials. Data from the first pivotal trial, which showed positive results across all primary analyses, were announced in June 2004 and reviewed by the UK regulatory authority. The UK regulators subsequently advised that this single pivotal trial would need to be supplemented by a further pivotal clinical study in MS spasticity in order to obtain a product licence for Sativex in this indication.
The second pivotal trial in MS spasticity, the results of which were reported in March 2006, showed a consistent positive treatment effect to the first pivotal trial. A pooled analysis of the full spasticity data-set also showed a positive effect for Sativex in this patient population. In the second pivotal trial, the per protocol analysis achieved statistical significance, whereas the outcome in the Intention to Treat (ITT) analysis was positive but non-significant. GW therefore stated at that time that it wished to consult with a number of different regulatory authorities in Europe, as well as with its European marketing partners, Bayer and Almirall, to determine whether it should move forward with a filing in this indication.
In the last few months, a series of positive meetings have taken place with officials from selected target European regulatory authorities. These meetings were attended by GW as well as its marketing partners and were aimed at providing advice as to the appropriateness of the data package for regulatory submission. These meetings are based on a preliminary view of the data and, as such, any advice provided is always subject to a detailed assessment in any future application. As a result of these meetings, GW and its marketing partners were in full agreement that the regulatory dossier should be submitted at this time.
Regulatory strategy for Sativex
This regulatory submission is part of a comprehensive strategy to secure regulatory approvals for Sativex across multiple indications in Europe, North America and the rest of the world. In addition to MS spasticity, Sativex is also in Phase III trials for three further separate indications: peripheral neuropathic pain, MS neuropathic pain and cancer pain. It is intended that, in accordance with conventional regulatory requirements, each regulatory submission for each target indication is supported by two pivotal Phase III clinical trials.
Indication: MS Neuropathic Pain
Sativex is approved in Canada in the indication of MS Neuropathic Pain under Health Canada’s Notice of Compliance with conditions policy.
GW has recently commenced a second pivotal Phase III study in this indication. This study supplements a completed positive pivotal Phase III study as well as a number of supportive studies. This second pivotal study, which is expected to report results in approximately one year, is intended to complete a data package to support a regulatory submission in Europe in this indication. In addition, the study will be submitted to the Canadian regulators in order to achieve a full Notice of Compliance.
Indication: Peripheral Neuropathic Pain
GW is now completing two pivotal Phase III studies in this indication, which are due to report results at the end of this year. These studies, together with a number of completed positive supportive studies, are intended to provide a data package to support a regulatory submission in Europe in this indication.
Indication: Cancer Pain
In January 2006, GW received permission from the US regulatory authority, the Food and Drug Administration (FDA) to commence Phase III trials in the US in the cancer pain indication. This follows the results of a positive Phase III trial carried out in Europe. Preparations to commence the first of two pivotal Phase III trials in this indication are well underway. Two pivotal Phase III trials in this indication will be carried out to provide a regulatory submission in both the US and in Europe.
About GW Pharmaceuticals
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under licence from the UK Home Office, the Company is developing cannabis-derived pharmaceutical products for patients with multiple sclerosis, neuropathic pain, cancer pain, spinal cord injury, rheumatoid arthritis, and other severe medical conditions.
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 and other neurological symptoms in patients who suffer from serious ailments.
For further information, please visit the Company’s website:www.gwpharm.com
Almirall is a consolidated international pharmaceutical company that researches, develops and commercialises its own R&D and licensed drugs with the aim of improving people’s health and quality of life.
Almirall is to invest 750 million euros in R&D over the next five years. The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD, psoriasis and rheumatoid arthritis.
Almirall, whose headquarters are in Barcelona (Spain), has a staff of over 3200 people, 500 of whom work in R&D and with approximately 1000 working internationally in Almirall´s affiliate companies.
Almirall´s products are currently present in approximately 100 countries. The company has direct presence in Europe and Latin America via affiliates.
For further information please visit the website at:www.almirall.es
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Haematology/Cardiology; Oncology and Primary Care. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
This news release may contain forward-looking statements that reflect GW's current expectations regarding future events, including the clinical development and regulatory clearance of GW'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 GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and GW’s other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.