- Epidiolex® (cannabidiol) NDA and MAA applications accepted for review –
- NDA PDUFA goal date scheduled for June 27, 2018 -
- Conference call today at 4:30 p.m. EST -
London, UK, Carlsbad, CA, 5 Feb 2017: GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces financial results for the first quarter ended 31 December 2017.
“With the Epidiolex regulatory applications accepted for review in both the US and Europe, and an assigned mid-year FDA decision date, 2018 is expected to be an exciting year for our Company with an anticipated first U.S. approval and launch. The commercial teams are making great progress toward launching Epidiolex with full conviction,” stated Justin Gover, GW’s Chief Executive Officer. “We also continue to see a significant flow of clinical data from the Epidiolex program through both medical meetings such as the American Epilepsy Society and in publication including our recent Lennox-Gastaut syndrome results in The Lancet. Beyond Epidiolex, we expect to progress a number of important pipeline programs during 2018 that have the potential to offer additional value.”
- Epidiolex (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
- NDA for the adjunctive treatment of seizures associated with LGS and Dravet syndrome accepted for priority review with planned PDUFA goal date of June 27, 2018
- European submission accepted for review by the EMA. Expected decision in Q1 2019
- Clinical data:
- First Phase 3 LGS trial published in The Lancet
- Second Phase 3 LGS trial publication anticipated in H1 2018
- Clinical trials
- Phase 3 trial in Tuberous Sclerosis Complex ongoing with data expected H2 2018
- Second Phase 3 trial in Dravet syndrome enrollment complete with data expected H2 2018
- Part A of two-part Phase 2/3 trial in Infantile Spasms underway
- FDA GMP inspections scheduled
- Expanded access program and open label extension:
- Over 2,000 patients now have been exposed to Epidiolex treatment
- 97 percent of patients who complete Phase 3 trials have entered long term extension
- Head of U.S. Sales appointed, completing the full U.S. commercial leadership team
- Active discussions in U.S. with a wide variety of payors and insurance programs
- EU commercial footprint now in place in five major European markets
- Life-cycle management
- Several new formulations of CBD in development including modified liquid formulations, a solid dose form and an intravenous formulation
- Intellectual property
- Several patent applications related to the use of CBD in certain forms of epilepsy being prosecuted with expected Track One decisions in Q2 2018
- Additional patent applications being filed as new data is generated
- Pipeline progress
- CBDV in epilepsy
- Data from CBDV Phase 2 partial-onset epilepsy study in adults expected in Q1 2018
- CBDV in Autism Spectrum Disorders
- 10-patient investigator-initiated expanded access program for seizures associated with autism underway
- Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder due to commence in Q2 2018
- Open label study in Rett syndrome due to commence in Q2 2018 and Phase 2 placebo-controlled trial in Rett syndrome due to commence in Q3 2018
- Orphan Drug Designation from FDA for CBDV for the treatment of Rett syndrome
- Sativex® (nabiximols)
- US development and commercialization rights reacquired – plans underway to commence US pivotal trial in MS spasticity
- CBD:THC in Glioblastoma
- Pivotal clinical development program plans under development
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
- Phase 1 trial complete
- Orphan Drug and Fast Track Designations granted from FDA and EMA
- CBDV in epilepsy
- Board appointments
- Three new independent members appointed to Board of Directors.
- Revenue for the three months ended 31 December 2017 of £5.7 million ($7.7 million) compared to £2.1 million for the three months ended 31 December 2016.
- Loss for the three months ended 31 December 2017 of £47.0 million ($63.3 million) compared to £15.6 million for the three months ended 31 December 2016.
- Cash and cash equivalents at 31 December 2017 of £414.8 million ($559.2 million) compared to £241.2 million as at 30 September 2017.
Solely for the convenience of the reader, the above balances have been translated into U.S. dollars at the rate on 31 December 2017 of $1.3482 to £1. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the first quarter 2018 financial results today at 4:30 pm EST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-481-4010 or 919-882-2331 (international). For both dial-in numbers please use conference ID # 13675963 and PIN: 24706.
About GW Pharmaceuticals plc and Greenwich Biosciences
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. GW, along with its U.S. subsidiary Greenwich Biosciences, is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex (cannabidiol), for which GW has submitted an NDA to the FDA and an MAA with the EMA for the adjunctive treatment of LGS and Dravet syndrome. The Company continues to evaluate Epidiolex in additional epilepsy conditions and currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for gliobastoma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.
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 Sativex and Epidiolex and the safety profile and commercial potential of Sativex and Epidiolex. 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 of uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex 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 U.S. Securities and Exchange Commission including the most recent Form 20-F filed on 4 December 2017. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations
401 500 6570
Sam Brown (U.S. Media Enquiries)
312 961 2502
FTI Consulting (EU Media Enquiries)
+44 (0) 7817 573 659