Cannabinoid player GW Pharma nears all-time highs on 3rd set of positive pivotal data

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.

Featured Webinar

From Concept to Market: Overcoming the Challenges of Manufacturing and Clinical Trials

In this webinar we will reveal the inner workings of the manufacturing and pharmacy department of a CRO/CDMO, so you understand the different regulatory and operational considerations faced by a clinical research pharmacy.

Learn how CRO/CDMOs successfully address operational and regulatory challenges for pharmaceutical and biotechnology clients; and how this can make the difference between study success or failure.

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.

Suggested Articles

Ironwood had once hyped this drug as a $2 billion-a-year asset, but IW-3718 has failed to live up to its high expectations.

The company describes the continuous glucose monitor as the world’s smallest and thinnest diabetes sensor, with a disc about the size of two pennies.

Junshi’s PD-1 blocker is already approved in China for metastatic melanoma, but the Shanghai-based biotech may soon add throat cancer to its label.