By Michael Berger
GW Pharmaceutical (GWPH: NASDAQ) announced fourth quarter and fiscal year 2014 financial results.
2014 was a big year for GWPH and 2015 should be even bigger. The company’s Epidolex program advanced significantly during the year and they received positive clinical data after treating 200 children with the drug. GWPH expects to report Phase 3 data from the Sativex cancer pain trials in early 2015. If they report positive data, the company would enable to file a New Drug Application (NDA) in the U.S.
2014 highlights from Epidiolex and Sativex
Epidiolex
- Epidiolex program for the treatment of childhood epilepsy program advanced significantly
- The company sponsored development programs in Dravet syndrome and Lennox-Gastaut syndrome (LGS)
- Phase 2/3 Dravet syndrome trial commenced in October 2014. Part A is on track to be completed in December and Part B expected to commence in Q1 2015
- Additional Phase 3 Dravet syndrome trial and two LGS Phase 3 trials are on track to commence in 1Q15
- Orphan Drug Designation was granted by the U.S. FDA for both Dravet syndrome and LGS
- Orphan Drug Designation was granted by the European Medicines Agency for Dravet syndrome
- Clinical effect data on 58 treatment-resistant children and young adults released in October 2014 showing promising signals of efficacy and safety
- Approximately 410 children and young adults now authorized for treatment with Epidiolex by FDA under 20 expanded access Investigational New Drug Applications (INDs)
- They started state-based collaborations for Epidiolex clinical trials in Georgia and New York
Sativex
- The first Phase 3 cancer pain trial recruitment was completed. The company expects to have initial top-line data available in early 2015. The second Phase 3 trial is expected to be completed in 1Q15 with data expected in 2Q15. The data will lead to a New Drug Application (NDA) filing with the FDA in the second half of 2015
- Fast Track designation awarded by FDA for treatment of cancer pain
- They signed an agreement with Ipsen as the exclusive distributor for Sativex in Latin America (excluding Mexico)
- Sativex is approved in 27 countries and available for use in 15 countries. Sales volume increased by over 50% in 2014 when compared to 2013.
Extensive cannabinoid product pipeline
- Additional epilepsy pipeline candidate GWP42006 (Cannabidivarin or CBDV), Phase 1 trial has been completed. Phase 2a trial due to start during the first half of 2015
- Phase 1b/2a trial of GWP42002:GWP42003 for the treatment of Glioma is advancing to second phase.
- Top line data from Phase 2a trial of GWP42003 extract for the treatment of ulcerative colitis has shown signals of efficacy in patients who received the treatment
- Phase 2a trial of GWP42003 for the treatment of schizophrenia commenced in March 2014. They expect to complete testing during the second half of 2015.
- Phase 2b trial of GWP42004 in type-2 diabetes commenced in March 2014 and is expected to be completed during 2016
Financial Highlights
- Total revenue for FY2014 was $48.7M. This is up from their 2013 numbers, $44.3M.
- GWPH generated a net loss after tax during 2014 of ($23.8m) due to the increased investment in R&D.
- Two follow-on offerings of American Depositary Shares on the NASDAQ Global Market raised approximately $212 million.
- Total cash and cash equivalents $266.8M
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