11th May 2015 11:28
LONDON (Alliance News) - GW Pharmaceuticals PLC Monday said its has begun a phase III trial of Epidiolex for the treatment of rare childhood epilepsy Lenoox-Gastaut syndrome, and posted a widened pretax loss for the first half of its financial year as it continued to drive development of Epidiolex.
GW Pharmaceuticals posted a pretax loss of GBP13.7 million for the half year to end-March, widened from a pretax loss of GBP10.6 million a year earlier, as revenue declined to GBP14.3 million from GBP15.0 million, and research and development costs rose to GBP30.5 million from GBP21.0 million.
The company began its phase III trials programme for Epidiolex, with the intention of releasing initial top-line data from the studies around the end of 2015. It is preparing for a new drug application submission to the US Food and Drug Administration in 2016.
The decline in revenue was due to lower research and development fees due to the end of its first phase III trial of Sativex in cancer pain, and a decline in sales of Sativex, which GW attributed to the decision of the Italian Medicines Agency to impost a maximum budget for Sativex sales in Italy.
Research and development costs increased due to costs related to the beginning of trials, headcount expansion, and other costs related to the development of Epidiolex.
Management and administrative costs also rose due to pre-launch commercialisation costs, and costs related to the establishment of its US operations.
GW raised USD167.8 million in an offering of 1.6 million American Depositary Shares at USD112.00 each last Monday, which it plans to use in order to expand its manufacturing capability and build up inventory ahead of a US launch of Epidiolex. If Epidiolex is approved it will also use the funds to develop other orphan indications for it, including Tuberous Sclerosis Complex, and advance its other pipeline opportunities.
Shares in GW Pharmaceuticals are trading down 2.2% at 588.70 pence Monday afternoon.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
Copyright 2015 Alliance News Limited. All Rights Reserved.
Related Shares:
GWP.L