GW Pharmaceuticals

[boulder]

GW Pharmaceuticals plc, the company licensed by the UK Home Office to work with cannabis and a range of controlled drugs for medical research purposes, announces its interim results for the six months ended 31 March 2003.

 

HIGHLIGHTS

Regulatory dossier for SativexÒ, GW’s lead cannabis-based medicine, submitted to the UK regulatory authority at end of March, on schedule

Bayer AG appointed as marketing partner for Sativex in the UK, GW’s first commercial partnership

Subject to UK regulatory approval, GW aims to make Sativex available on prescription by the end of 2003

Following positive results of four Phase III trials in November 2002, recruitment continues to proceed as planned for five ongoing Phase III trials

Progress continues with Phase II research into the use of cannabinoids in novel therapeutic areas

Development of Advanced Dispensing System technology continues for use with anti-addiction products as well as for other applications

Net loss for the six months to 31 March 2003 of £6.7m, in line with budget

Cash and short term deposits at 31 March of £13.7m, supplemented by signature fee of £5m from Bayer received since the half-year end

 

Dr Geoffrey Guy, Executive Chairman of GW Pharmaceuticals, said: “The first six months of the year has seen GW achieve a number of significant milestones, all in accordance with previously stated timescales. In particular, GW submitted its regulatory dossier for Sativex to the UK regulatory authority and also entered into an agreement with Bayer to market Sativex in the UK. The Bayer agreement is GW’s first commercial collaboration to date and provides a clear demonstration of confidence on the part of a world leading pharmaceutical company in GW’s product development capability and the quality of the science underpinning its programme.

 

“GW’s achievements over recent years provide a solid platform for growth. We are confident that GW is on track to secure regulatory approvals, commercial partnerships and launches for Sativex around the world as well as progress new opportunities from our earlier stage research programmes. We have considerable ambitions for the next phase in the Group’s development and believe that we now have the elements in place to build a major UK pharmaceuticals business.”

 

 

A presentation for analysts is taking place today at 09.30 at Weber Shandwick Square Mile, Fox Court, 14 Gray’s Inn Road, London WC1. An audio webcast of the presentation will be available on GW’s website at www.gwpharm.com from 15.00 today.

 

Interim Results For The Six Months To 31 March 2003

 

During the first six months of the year, GW has made progress in all key areas, consistent with targets set out at the beginning of the year. In particular, the Group has filed its first regulatory dossier and has appointed Bayer AG as its first marketing partner for its lead product, Sativex®. Expenditure is in line with budget and the Group’s cash position remains strong.

 

Sativex® Dossier Submitted in UK

 

In November 2002, GW announced positive results from each of four Phase III clinical trials in patients with Multiple Sclerosis and Neuropathic Pain. These four randomised, double-blind, placebo-controlled Phase III trials included approximately 350 patients. In the trials, Sativex achieved statistically significant reductions in Neuropathic Pain in comparison with placebo, as well as statistically significant improvements in other symptoms of Multiple Sclerosis, most notably spasticity and sleep disturbance. These findings are consistent with results from Phase II trials.

 

Sativex, GW’s lead product, is a whole plant medicinal cannabis extract containing Tetranabinex™ extract (tetrahydrocannabinol, “THC”) and Nabidiolex™ extract (cannabidiol, “CBD”) as its principal components. The medicine is administered by means of a spray into the mouth.

 

At the end of March, in accordance with the Group’s target timescales, GW submitted its regulatory dossier for Sativex to the UK regulatory authority, the recently re-named Medicines and Healthcare Products Regulatory Agency (“MHRA”). The dossier submission was a key milestone for GW resulting from considerable effort and commitment on the part of the whole company.

 

GW has applied to the MHRA for an authorisation to market Sativex in two therapeutic indications:

- relief of symptoms in patients with Multiple Sclerosis

- relief of Neuropathic Pain (nerve-damage pain)

 

GW has previously stated that, subject to MHRA approval, it hopes to be able to make Sativex available for prescription by doctors in the UK by the end of 2003. GW believes that this target timescale remains on track.

 

Market Opportunity for Sativex

 

We believe that the market opportunity for Sativex in its initial target markets of MS and Neuropathic Pain is substantial. In Europe alone, there are approximately 500,000 MS sufferers and 4 million patients with Neuropathic Pain, with both of these patient groups being poorly served by existing therapies. We expect Sativex to be the world’s first cannabis-based medicine to be launched for these indications and we believe the product will represent a significant advance in the management of these debilitating conditions.

 

Agreement with Bayer AG

 

In the last annual report, we stated that the next phase of the Group’s growth would be characterised by commercial partnerships and associated revenues. In May, GW and Bayer AG (“Bayer”) entered into an exclusive marketing agreement for Sativex. This is GW’s first commercial collaboration.

 

 

GW’s commercial strategy is to maximise the value of its products by entering into agreements at a late stage of development. The terms of the Bayer agreement reflect the merits of this strategy. The financial terms of this partnership have been established to yield equal long term value to each partner. GW has maintained a significant share of long term product revenues whilst benefiting from a signature fee, an innovative advance working capital facility and, subject to MHRA approval, milestone payments which would further enhance the Group’s cash position.

 

Bayer is one of the world’s leading companies in the health care and medical products industry and is well placed to maximise the market opportunity for GW’s product.

 

Bayer has obtained exclusive rights to market Sativex in the UK. Bayer also has the option for a limited period of time to negotiate the marketing rights in other countries in the European Union and selected other countries around the world.

 

In addition to the two indications for Sativex detailed above, Sativex and a THC extract product are also undergoing Phase III trials for the treatment of cancer pain. If approved, Bayer will also market these medicines for cancer pain in the UK.

 

GW has received a signature fee of £5 million and will receive additional milestone payments up to a maximum amount of £20 million, subject to regulatory approvals being granted in the UK for the initial indications of MS, Neuropathic Pain and cancer pain. Total fees are £25 million. In the event that Bayer exercises the option for countries outside the UK, additional milestones would be payable on a country by country basis.

 

Of the £25 million payments, £10 million can be drawn by GW in advance as an interest-free working capital facility to support ongoing preparations for market launch of Sativex. The facility can be drawn by GW at its discretion until MHRA approval is obtained. On approval, Bayer has the option to convert the facility into a milestone payment or to convert into GW shares at an agreed premium to the share price at the time of conversion. The facility is subject to additional conditions if MHRA approval is not obtained by 30 September 2004.

 

GW is to be responsible for completing steps to secure regulatory approvals and for commercial product supply to Bayer. GW will manage the supply of product through a range of contract manufacturing partners, arrangements for which are all in place.

 

GW and Bayer are now working closely to prepare for market launch in the UK.

 

Phase III trials

 

In addition to the four completed trials reported in November 2002, GW has a further five Phase III trials in progress. These trials are examining the effectiveness of Sativex in the following medical conditions:

Cancer Pain

Neuropathic Pain in Spinal Cord Injury

General Neuropathic Pain (Allodynia)

Spasticity in MS

Bladder Dysfunction in MS

 

These trials continue to recruit patients as planned. Results from a number of these trials are expected around the end of 2003 or early 2004.

 

International Activity

 

In addition to the UK, GW has established clinical trial centres in Ireland, Belgium, Romania, and Canada. The Group maintains ongoing communication with regulatory authorities and government officials from a range of countries around the world. Following UK regulatory approval, GW will be focusing on securing regulatory approval and the commercialisation of Sativex on the international stage.

 

 

Cannabinoid Research Institute

 

The Cannabinoid Research Institute (“CRI”), based in Oxford under the direction of Dr Philip Robson, GW’s Medical Director, has continued to progress pre-clinical and clinical research in a range of therapeutic areas. One of the key objectives of the CRI is to undertake exploratory clinical evaluation of GW’s cannabis-based medicines to provide a platform for the next wave of products from the pipeline.

 

Studies are underway in Rheumatoid Arthritis, Peri-operative pain, and Glaucoma. Other trials are being planned in a range of additional target therapeutic conditions.

 

GW continues to carry out research in conjunction with its international network of leading cannabinoid scientists. The company is increasing its activity in producing publications and scientific presentations at international conferences.

 

Advanced Dispensing System

 

GW’s Advanced Dispensing System (ADS) technology provides the ability to monitor and, if required, control drug usage in real time. The technology also provides a secure and tamper-proof means of dispensing controlled drugs.

 

Last year, GW established a Home Office endorsed collaboration with the National Addiction Centre to evaluate the use of ADS to dispense methadone and diamorphine in the treatment of drug addiction.

 

If the development of anti-addiction products is successful, we will look to exploit further opportunities for ADS over the coming few years. GW believes that the potential applications of this technology are considerable.

[Alison Myrden]

Thanx for posting sopme amazing information guys. Geoffery Guy has helped me to meet some of his co-workers and they are now very dear friendsof mine in this issue....

 

 

LOTS going on in Canada as well right now.....

 

 

Check it out......

Love and a squish,

Alison

xx

www.themarijuanamission.com