Analyst: GW Pharma Has Started Laying The Groundwork For Taking Epidiolex To Market

Elemer Piros of Cantor Fitzgerald maintained an Overweight rating and $208 price target on GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) after the developer of cannbinoid products reported its fiscal second-quarter results.

Piros' main takeaway from the report and conference call is that GW Pharmaceuticals is on track to file its NDA (new drug application) for its Epidiolex therapy in mid-2017. The company also expects to submit its European filing in the bottom half of 2017.

Piros highlighted two key portions in progress to support the Epidiolex:

• An integrated safety analysis of over 1,500 patients from clinical studies and the expanded access program.
• Manufacturing data from the manufacturing processes, including scaled materials.

The two elements will likely be the only determining factors relating to the timing of the NDA submission, but is nevertheless expected by the middle of the year.

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Laying The Groundwork

Piros noted that a subsidiary of GW Pharmaceutical called Greenwich Biosciences is already working on a pre-commercial strategy to expand its workforce in advance of the launch of Epidiolex.

The company laid out its vision for a sales force of up to 60 representatives, which can reach up to five thousand targeted U.S. physicians. In addition, the company also began engaging payors on awareness of patient need for Epidiolex and its pricing.

"We believe these efforts will set a meaningful foundation for Epidiolex's commercial launch, which we estimate will initiate in 2018," Piros wrote.

The analyst noted the company expects a Phase 2 readout from its CBDV program involving adult seizure patients in the fourth quarter of 2017.

Bottom line, the analyst is "encouraged" by the company's progress in the most recent quarter.