PrintContact
 
  • Home
  • About Us
  • Sativex
  • R&D
  • Investors
  • Media
GW Pharmaceuticals
  • Press Releases
  • Media Contacts
  • Notes to Editors
  • Image Library
  • Home
  • Media
  • Press Releases
  • Preliminary Results for the Year Ended 30 September 2004

Preliminary Results for the Year Ended 30 September 2004

 

Preliminary Results for the Year Ended 30 September 2004

19  January  2005

GW Pharmaceuticals announces its Preliminary Results for the year ended 30 September 2004

Highlights

 

  • Qualifying notice received for first regulatory approval of Sativex® in Canada
  • UK regulatory approval process for Sativex ongoing. Medicines Commission hearing expected within six months
  • Positive results from Phase III clinical trial in cancer pain (announced separately today)
  • Further positive results from Phase III clinical trials in neuropathic pain and spasticity in Multiple Sclerosis
  • Positive results from Phase II clinical trial in rheumatoid arthritis
  • Patient recruitment complete for two further Phase III trials. Results due in first half of 2005
  • Further regulatory filings planned in 2005, including a US IND application
  • Second generation Advanced Dispensing System methadone technology developed and operational
  • Net loss for the year to 30 September 2004 of £13.7m (2003: £8.1m)
  • Cash and short term deposits at 30 September 2004 of £17.8m

 

 

Dr Geoffrey Guy, Executive Chairman, commented: “This has been a year of significant achievement. Although the UK regulatory process for Sativex has been slower than anticipated, we were delighted in December 2004 to receive notice that Sativex qualifies for approval in Canada. We therefore expect shortly to achieve our first regulatory approval, a key milestone in the history of GW. In addition, we have announced a series of positive results from clinical trials, including three new Phase III trials, which further enhance the wealth of efficacy data to support the potential of Sativex.

 

“Regarding the UK regulatory process, we have now resolved all quality and safety issues and we remain determined to resolve the one outstanding efficacy-related issue at the Medicines Commission. The outcome of this Commission hearing should be known in the summer.

 

“With our first approval imminent as well as the breadth of positive clinical data which continues to be generated, we have good reason to be excited about the year ahead. We expect 2005 to be the year of our first product launch, a time of restored momentum, as well as a financial turning point as we start to generate commercial revenues from product sales.”

 

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.

 

Enquiries:

 

GW Pharmaceuticals plc(19/01/05) 020 7067 0700

Dr Geoffrey Guy, Chairman Thereafter: 01980 557000

Justin Gover, Managing Director

Weber Shandwick Square Mile020 7067 0700

Kevin Smith / Sarah MacLeod

 

View the webcast of the analyst presentation

 

View the complete document [PDF, 134KB, opens in a new window].

 

To view this document you will need Adobe Acrobat Reader. Download this software.

 

 
 
 

© GW Pharmaceuticals 2009

  • Home
  • Sitemap
  • Accessibility
  • Disclosure & Disclaimer
  • Contact
  • Email Alerts
 

Website designed and developed by www.emperordesign.co.uk