GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) stock surged over 8.7% on April 17th, 2018 as US FDA approved their experimental medication derived from cannabis.
As per the Food and Drug Administration staff, the group offered “substantial evidence” of the drug’s effectiveness. Moreover, the medication would treat seizures related with two rare forms of epilepsy that typically affect children. Even though the medication is showing a higher risk of liver injury, FDA staff says it could be managed.
The group hopes to market the drug under the name Epidiolex which, is produced in the U.K. from a plant that has been bred to have a high cannabidiol, or CBD, content.
Earlier, the group notified that they have receipt of Notices of Allowance for five new Epidiolex® patent applications that would be listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) if the NDA for Epidiolex is approved. After they are issued, these patents are set to expire in 2035.
Management believes that their achievements have positioned them for a midyear NDA approval and an expected U.S. launch in the second half of the year. In Europe, they expect an approval decision in the first quarter of 2019. Moreover, the group expects the results of their second LGS Phase 3 trial to be published in the first half of this year, also in a top tier journal.
To achieve their milestones, they have finished the follow-on offering raising net proceeds of approximately $300 million in December. The funds would be used for Epidiolex launches in the U.S. and Europe as well as continuing to expand manufacturing capacity and advance the pipeline.
On the other side, the group is also focusing on evaluating Cannabidivarin or CBDV as add-on therapy in adult patients with inadequately controlled focal seizures for which they are conducting a Phase 2 double-blind randomized placebo-controlled trial. Recruitment in this trial has finished with 162 randomized patients. They are expecting top line results from this trial to become available this quarter.