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GW Pharmaceuticals's cannabidiol epilepsy drug ready for NDA filing

GW Pharmaceuticals says it is on track to file a New Drug Application for its cannabis-based epilepsy treatments following positive Phase III trials.
An epileptic orphan
GW is advancing an orphan drug program in the field of childhood epilepsy.

GW Pharmaceuticals plc (NASDAQ:GWPH, LON:GWP) said it was on track for an NDA (New Drug Application) filing for both its cannabis-derived Dravet Syndrome and Lennox-Gastaut Syndrome indications following positive Phase III trials.

“We believe that these Phase III data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in these highly treatment-resistant populations together with an acceptable safety and tolerability profile,” stated chief executive Justin Gover.

Last month, GW raised just over £200mln (US$273mln) from a follow-on offering.

“Our recent successful financing has provided GW with the necessary capital to move forward with confidence in preparing to execute a highly successful launch," added Gover.

The group reported losses for the nine months ended June of £46.7mln (US$62.2mln) compared to £32.3mln reported last year. It said the loss reflected investment in the Phase III pivotal trials program.

It ended the period with £191.2mln (US$254.3mln) cash and cash equivalents, down from the £234.9mln last reported in September.

GW is developing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex, or cannabidiol, derived from the cannabis plant.

The group also announced today that its chief medical officer Stephen Wright is to retire in May next year after serving 13 years on the board.

Wright was instrumental in the development of the cannabinoid drug and bringing the pushing the group towards a NASDAQ listing, said a statement Tuesday.

GW will look to hire a successor by May 2017.



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