GW
Pharmaceuticals plc, the company which develops a
range of new medicines based on cannabis and other
controlled drugs, announces its preliminary results
for the year ended 30 September 2003.
Highlights
*
Regulatory dossier for SativexT submitted to the UK
authorities in March 2003
*
Sativex regulatory assessment process well advanced.
Completion expected during the second quarter of 2004.
*
Production, supply chain and marketing teams prepared
for launch of Sativex
*
Marketing arrangements signed with Bayer in UK and
Canada providing GW with total potential milestone
payments in excess of £30m as well as a significant
share of long term product sales revenues
*
Bayer extend option to licence Sativex in Europe,
Australia and New Zealand into 2004
*
£19m net raised from share placing in June 2003
*
Five Phase III clinical trials recruiting as planned
and due to report in 2004
*
Net loss of £8.1m (2002: £11.2m) in line with expectations
*
Cash and short term deposits of £32.0m at year end
(2002: £20.2m)
Dr
Geoffrey Guy, Executive Chairman, commented: ñHaving
filed the UK regulatory submission for Sativex in
March 2003, the application is now well advanced towards
achieving the critical milestone of regulatory approval.
The final stages in the regulatory process are underway;
the timing of completion of this process is a matter
of scheduling within the regulatory agency and is
currently expected to occur during the second quarter
of 2004.
ñGW
and Bayer are working very closely together to prepare
for the anticipated launch of Sativex and we expect
to be able to move swiftly towards market launch following
a successful approval. The Bayer agreement, together
with a successful institutional share placing undertaken
last summer, has significantly enhanced the Group÷s
financial position.
ñWe
anticipate that 2004 will see the regulatory approval
and launch of Sativex. Achievement of this milestone
would represent a transformation for GW as a pharmaceutical
company and provide validation for the future therapeutic
and market opportunities in our product pipeline.
We have every reason to be extremely excited about
the year ahead.î
For
more info on GW & Sativex go to http://www.gwpharm.com/faqs.asp