A bonus windfall from its Nasdaq float is enabling Cambridge UK medical technology business GW Pharmaceuticals to accelerate a development programme for childhood epilepsy in the US.
Gover revealed: We believe our lead epilepsy product candidate, Epidiolex, has the potential to meet significant unmet needs in the treatment of orphan childhood epilepsy syndromes such as Dravet syndrome and Lennox-Gastaut syndrome.
With the new funds raised we have the financial strength to accelerate this development program whilst retaining global commercial rights.
In addition to our orphan epilepsy programme, as we move through 2014, we expect a significant amount of milestones, including Phase 3 cancer pain data for Sativex as well as important clinical progress across our robust pipeline of cannabinoid product candidates.
GW is investing heavily in its pipeline of cannabis-based products, as evidenced by the Q1 2014 results out today. Orphan drug designation for Epidiolex to treat Dravet syndrome has already been granted by the US FDA.
Seven expanded access Investigational New Drug Applications (INDs) have been granted by the FDA to US physicians to treat with Epidiolex approximately 125 children suffering from intractable epilepsy syndromes. Other INDs have been submitted.
Patients are starting treatment with Epidiolex in two expanded access INDs in New York City and San Francisco and initial treatment data is expected mid-2014.
GW is also advancing Sativex programme developments with Phase 3 cancer pain trials in recruitment; more territories in Europe and, most recently, Latin America have been lined up for Sativex in treatment of spasticity in MS.
Total revenue for the three months ended December 31 was up to of 7.5 million ($12.4 million) compared to 5.2m for the three months ended December 31, 2012.
Net loss after tax for the three months was 2.8m ($4.7m) compared to a profit of 2.1m for the same quarter of 2012.
Originally posted here:
$101m Nasdaq windfall boosts child epilepsy venture