- Total preliminary net product sales of approximately
- Total Epidiolex® preliminary net product sales of approximately
- Pivotal US clinical program for nabiximols in MS spasticity underway. Initial data expected in 2021 -
“Epidiolex sales increased by over 70% in 2020 despite the challenges of COVID-19, reflecting the positive impact this medicine has on patients as well as the performance of our commercial team. We remain encouraged by our patients’ experience on this product, as demonstrated by high persistence and refill rates. This, combined with our expansion of payer coverage and the recently approved
Preliminary Unaudited Fourth Quarter and Full-Year 2020 Net Product Sales
Based on preliminary unaudited financial information, the Company expects total net product sales to be approximately
Key Priorities for 2021
EPIDIOLEX commercialization:
- Continue to drive revenue growth in US and
Europe :
• Execute on TSC label expansion and continued penetration in Dravet and LGS
• Build further on expanded payer coverage achievements
• Accelerate adoption across a broader prescriber base
• Increase penetration in long-term care segment
• Continue launches inGermany andUK and achieve successful pricing and reimbursement, and launch execution inFrance ,Spain andItaly , as well as other European countries
• Obtain approval of theTuberous Sclerosis Complex indication inEurope - Supplement existing 14 Orange Book listed patents (expiry 2035) with additional use patents, and obtain grant of the Epidiolex “composition” patent
- Commence pivotal trial in fourth target orphan epilepsy indication
Nabiximols in the US:
- Continue recruitment of two ongoing pivotal MS spasticity trials and commence three additional pivotal trials in MS spasticity
- Achieve data from at least one pivotal MS spasticity trial in 2021
- NDA submission expected following first positive pivotal MS spasticity trial
- Commence clinical program to expand future label to include spasticity associated with Spinal Cord Injury
Additional pipeline:
- Continue recruitment of ongoing Phase 2b study of a cannabidiol formulation for the treatment of schizophrenia
- Conduct placebo-controlled trials with both CBDV and CBD in autism
- Advance NHIE clinical program utilizing an intravenous formulation of cannabidiol
- Complete Phase 1 trial for novel botanical drug candidate GW541
- Advance first novel NCE cannabinoid candidate into Phase 1
About
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. The Company’s lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the
Forward-looking statements
This news release contains forward-looking statements that reflect GW’s current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of EPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral solution and Sativex® (nabiximols), and the safety profile and commercial potential of both medicines, and those associated with the COVID-19 pandemic. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, and the acceptance of EPIDIOLEX®/EPIDYOLEX®, Sativex® and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the
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