GWPH: Several Catalysts in the Pipeline

12/09/2015 9:00 am EST

Focus: CANNABIS INVESTMENTS

Michael Berger

President & Founder, Technical420.com

Despite the fact that shares are trading well below its average Wall Street price target, Michael Berger, of Technical420.com, thinks recent favorable data coupled with a deep pipeline of products supports his expectation that 2016 will be a milestone year for this prescription cannabinoid medicine company.

GW Pharmaceuticals plc (GWPH) is a pharmaceutical company focused on discovering, developing, and commercializing novel therapeutics from its proprietary cannabinoid product platform. GWPH commercialized the world's first plant-derived cannabinoid prescription drug, Sativex, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States.

GWPH has an extensive product pipeline which should enable to the company to be a major player for years to come. GWPH recently reported data pertaining to its Epidiolex product and we expect 2016 to be a milestone year for the company. 

Favorable Data Presented at the American Epilepsy Society’s Annual Meeting

On Monday, the largest CBD study presented efficacy and safety data on GWPH’s Epidiolex product. The study involved 261 people (average age was 11) who suffer from severe epilepsy and have not responded adequately to other treatments.

After three months of treatment, the frequency of all seizures was reduced by a median of 45% in all participants. Almost half (47%) of the participants experienced a greater than 50% reduction in seizures and 9% were seizure-free. Among specific patient populations, patients who suffer from Dravet Syndrome had a 62% reduction in seizures and 13% were seizure-free. Patients with LGS experienced a 71% reduction in atonic seizures.

Adverse effects occurred in more than 10% of participants with the most common being somnolence, diarrhea, and fatigue. Only 4% of participants withdrew from the study as a result of the adverse effects. 

Continues to Advance its Epidiolex Product

Although GWPH has several products in its pipeline, none is more important than its Epidiolex product. During the quarter, GWPH started and completed the recruitment of multiple Phase 3 trials for Epidiolex and the expansion of its expanded access program which yielded promising safety and efficacy data. Some of the projected milestones for 2016 include:

  • The first Phase 3 Dravet syndrome trial was fully enrolled and data is expected during the first quarter of 2016
  • The first and second Phase 3 LGS trials were fully enrolled and GWPH expects to release data in the second quarter of 2016
  • The second Phase 3 Dravet Syndrome trial is ongoing and GWPH expects to release data in mid-2016
  • GWPH plans to submit a new drug application to the FDA in the fourth quarter of 2016
  • Phase 3 Tuberous Sclerosis Complex trial is expected to start during the first quarter of 2016
  • During the second half of 2016, GWPH will commence additional clinical development for Epidiolex beyond initial three indications.

Deep Pipeline of Products Provides Several Catalysts

GWPH continues to make advancements in its pipeline of cannabinoid products. Some of the highlights include:

  • Phase 2a CBD schizophrenia study data showed a positive proof-of-concept with a reassuring safety profile
  • GWPH expects to release data from its Phase 2 CBDV epilepsy study (adults) during the second half of 2016
  • Expects to commence Phase 1 clinical testing for Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) during the second half of 2016
  • Expects to commence clinical trials within the field of autism spectrum disorders during the second half of 2016
  • The Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme is fully enrolled and GWPH expects to release data in mid-2016
  • The Phase 2 study in type-2 diabetes is fully enrolled and GWPH expects to release data in mid-2016
  • Expects to release data from its Phase 2 study of Sativex in spasticity due to cerebral palsy in mid-2016

Outlook

GWPH has fallen more than 19% from its highs on October 19 and shares are trading well below its average Wall Street price target. We expect favorable data on its Epidiolex product to be a major catalyst during 2016 and investors interested in the biotech sector should closely monitor GWPH.

Michael Berger, Founder and President, Technical420.com

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