GW Pharmaceuticals has announced financial results for the fourth quarter and full-year ended December 31, 2019. The British biopharmaceutical manufacturer in pole position in the commercialisation of cannabinoid prescription medicines said Epidiolex net product sales reached $104.5m in Q4 and $296.4m in the first full year of sales.
The financial report revealed a total revenue of US$109.1 million in Q4 and $311m for the full year.
“2019 was an exceptional and transformative year for GW, led by the successful launch of Epidiolex in the US and approval in Europe," said Justin Gover, GW’s Chief Executive Officer.
"The positive impact this medicine has had on thousands of patients and their families provides a compelling foundation for continued growth in 2020,” he added
Gover said GW is expecting 2020 to be an important year for its growing and developing product pipeline beyond Epidiolex as the company build on its knowledge in cannabinoid science.
"We are focused on advancing nabiximols in the US in several indications and clinical programs with other potential products whilst continuing to bring Epidiolex to more patients in the US and Europe," he revealed.
Operation highlights
Commenting on work in progress around the Epidiolex (cannabidiol) product, GW revealed 2020 will see the company focus on broadening prescriber base, expanding payer coverage, entering long term care segment, and expected launch of TSC indication.
GW said Epidiolex's European launch will continue with launches in France, Spain and Italy expected later this year.
Clinical progress is also underway with further indications including Tuberous Sclerosis Complex (TSC) sNDA, which for the company has filed with the FDA earlier this month, and MAA submission to EMA expected in Q1 2020.
Phase 3 trial in Rett Syndrome also progresses well. The company said several new formulations of CBD are advancing into additional Phase 1 studies in 2020, including modified oral solution, and capsule.
GW has also improved intellectual property rights and exclusivity. In addition to orphan exclusivity, nine granted patents are listed in “Orange Book” and align directly with Epidiolex FDA label with expiry dates to 2035.
Other highlights include:
- Epidiolex composition patent application recently published
- 2 new allowed patents broadly covering use in LGS and Dravet syndrome
- Additional patent applications under review, including patents related to the use of Epidiolex in TSC and other indications
Pipeline in progress
- Nabiximols (Sativex outside of the US)
- Multiple Sclerosis spasticity -3 positive Phase 3 trials completed in Europe
- US pivotal clinical program expected to commence in Q2 2020 to augment existing data package
- Multiple Sclerosis spasticity -3 positive Phase 3 trials completed in Europe
- Spinal cord injury spasticity - clinical program expected to commence in H2 2020
- PTSD – clinical program expected to commence in H2 2020
- Schizophrenia (GWP42003)
- Positive Phase 2a trial published and Phase 2b trial expected to commence H1 2020
- CBDV in autism
- 30-patient open label study in autism underway. Initial data expected in 2020.
- Investigator-led 100 patient placebo-controlled trial in autism underway
- Open label study in Rett syndrome and seizures underway
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
- Phase 1b safety study in patients underway
- Orphan Drug and Fast Track Designations granted from FDA and EMA