GW Pharmaceuticals ($GWPH) has been the subject of acquisition speculation. In fact, it has reportedly hired Morgan Stanley to evaluate its field of options--despite not being officially for sale. Now, it’s clocked a third set of positive pivotal trial data, which makes it an even more attractive potential purchase.
The London-based company was up 16% in early trading on the latest data, giving it a valuation of about $2.7 billion. That puts it at a share price of around $125, which is near its 52-week and all-time high.
The data were a second set of positive Phase III results from Epidiolex (cannabidiol or CBD) to treat seizures in Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. Patients on a high dose of Epidiolex saw a reduction in monthly drop seizures of 42%, while low-dose patients achieved a 37% decline and placebo patients saw a 17% reduction.
The company plans to submit a single NDA in LGS and Dravet syndrome, another form of childhood-onset epilepsy in which it has had positive pivotal data. It plans to do so during the first half of next year. GW reported that in a mid-July meeting with the FDA, the agency confirmed that strategy of one submission in both of these indications.
“The positive outcome in this second trial of Epidiolex in patients with Lennox-Gastaut syndrome demonstrates the effectiveness of this product in this particularly difficult to treat, childhood-onset epilepsy,” said principal investigator Dr. Orrin Devinsky of New York University Langone Medical Center’s Comprehensive Epilepsy Center in a statement.
He continued, “The data from the Epidiolex Dravet and LGS studies offers the prospect of an FDA-approved CBD medicine that shows both clinically meaningful seizure reduction and a consistent safety and tolerability profile. I believe Epidiolex has the potential to become an important new option within the field of treatment-resistant epilepsy.”
The company does not expect the new data will precipitate an additional pre-NDA meeting with the FDA. It anticipates a label that includes both the high Epidiolex dose of 20 mg per kg and the low dose of 10 mg per kg.
Epidiolex has received orphan drug designation from the FDA for Dravet syndrome and LGS, as well as fast-track designation for Dravet.