GW Pharmaceuticals (GWPH) Posts Q1 Loss of 4c/Share; Epidiolex IND Now Open for Phase 2/3

GW Pharmaceuticals plc (NASDAQ: GWPH) reported Q1 EPS of ($0.04), $0.44 better than the analyst estimate of ($0.48). Revenue for the quarter came in at $12.55 million versus the consensus estimate of $12.48 million.

GW Pharma also announced that the Company has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug application (IND) is now open for Epidiolex in the treatment of Dravet Syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. GW expects to commence a Phase 2/3 clinical trial in the second half of 2014.

Epidiolex has already received orphan drug designation from the FDA for the treatment of Dravet syndrome.

"The acceptance of this IND by the FDA is a significant milestone for Epidiolex and for children with Dravet syndrome for whom existing anti-epileptic medicines often do not provide adequate relief," stated Justin Gover, GW's Chief Executive Officer. "This journey began with requests from the U.S. epilepsy physician and patient community to utilize Epidiolex and has now led to GW embarking on its own formal development program with a view to seeking market authorization from the FDA as rapidly as possible. We are committed to providing a prescription cannabidiol (CBD) medicine for children with Dravet syndrome who have exhausted all other therapeutic options."

The Phase 2/3 trial is a two-part randomized double-blind, placebo-controlled parallel group dose escalation, safety, tolerability, pharmacokinetic and efficacy trial of single and multiple doses of Epidiolex to treat Dravet syndrome in children who are being treated with other anti-epileptic drugs. Part one comprises the pharmacokinetic and dose-finding elements of the trial in a total of 30 patients over a 3 week treatment period. Part two is a placebo-controlled safety and efficacy evaluation of Epidiolex over a 3 month treatment period in a total of 80 patients. All patients who participate in the study will be eligible to receive Epidiolex under a long term open label extension protocol.

GW anticipates commencing an additional Phase 3 trial in Dravet syndrome in the first quarter of 2015 in parallel with part two of the first Phase 2/3 trial.

In addition to Dravet syndrome, GW plans to conduct a clinical development program for Epidiolex in the treatment of Lennox-Gastaut syndrome (LGS). Following receipt earlier in 2014 of orphan drug designation by the FDA in LGS, GW expects to hold a pre-IND meeting with the FDA for Epidiolex in the treatment of LGS in mid-2014, and aims to conduct two Phase 3 trials in LGS during 2015.

For earnings history and earnings-related data on GW Pharmaceuticals plc (GWPH) click here.

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