GW Pharmaceuticals plc Reports Fourth Quarter and Year-End 2016 Financial Results and Operational Progress
– Three Positive Phase 3 Epidiolex clinical trials reported in 2016 –
– NDA submission and launch preparation on track –
– Conference call today at 8:00 a.m. EST –
LONDON, Dec. 05, 2016 (GLOBE NEWSWIRE) — 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, announced financial results for the fourth quarter and year-ended 30 September 2016.
In 2016 GW has completed three positive Phase 3 trials for Epidiolex in patients with two different rare treatment resistant forms of childhood-onset epilepsy and we are making good progress towards an NDA submission. Our sights are now focused on Epidiolex approval and accelerating our preparations for a highly successful launch. Our goal is to provide the children and their families suffering from these highly treatment-resistant forms of childhood-onset epilepsy with a much needed new prescription option as quickly as possible.
Justin Gover, GW’s Chief Executive Officer
2016 OPERATIONAL HIGHLIGHTS
- Epidiolex® (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
- Phase 3 trials:
- Positive results in a pivotal Phase 3 Dravet syndrome trial
- Positive results in two pivotal Phase 3 LGS trials
- Positive data presented at the American Epilepsy Society Annual Meeting
- Positive Dravet syndrome pre-NDA meeting held with FDA in July 2016
- Positive CMC pre-NDA meeting held with FDA in November 2016
- NDA submission for both Dravet and LGS indications expected at end of H1 2017, just 3 years since opening of IND
- Preparations advancing for EU regulatory submission in H2 2017
- Manufacturing scale-up:
- Manufacturing scale-up on track to deliver significant commercial launch inventory
- Expanded access program and open label extension:
- 98% of patients who complete Phase 3 trials have entered long term extension
- Over 1,000 patients now on Epidiolex treatment
- NDA submission to include safey data from over 1,500 patients and over 400 patients with 1 year or more continuous exposure
- Withdrawal rate in long term studies approx 20%
- US commercial team build underway and pre-launch preparations advancing well
- EU commercial team now being established
- Additional indications:
- Phase 3 trial in TSC ongoing
- Two part Phase 3 trial in IS commenced in December 2016
- Intellectual Property:
- Patent portfolio being prosecuted with claims directed to the use of CBD in the treatment of epilepsy seizure subtypes and epilepsy syndromes
- Phase 3 trials:
- Advanced clinical programs in multiple cannabinoid pipeline product candidates:
- CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected mid-2017
- CBDV pre-clinical research ongoing within field of autism spectrum disorders. Phase 2 trials expected to commence in Q3 2017
- Orphan Drug Designation from FDA for CBDV for the treatment of Rett syndrome
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
- Phase 1 trial commenced in December 2016
- Orphan Drug and Fast Track Designations granted from FDA and EMA
- THC:CBD for the treatment of Recurrent Glioblastoma Multiforme (GBM)
- Phase 1b/2a study completed — data expected Q1 2017
- Orphan Drug Designation from FDA
- Sativex® Phase 2 study in children with spasticity due to cerebral palsy completed — data expected Q1 2017
- Revenue for the twelve months ended 30 September 2016 of £10.3 million ($13.3 million) compared to £28.5 million for the twelve months ended 30 September 2015.
- Loss for the twelve months ended 30 September 2016 of £63.7 million ($82.2 million) compared to £44.6 million for the twelve months ended 30 September 2015.
- Cash and cash equivalents at 30 September 2016 of £374.4 million ($483.4 million) compared to £234.9 million as at 30 September 2015.
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the fourth quarter and year-end 2016 financial results today at 8:00 a.m.. 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, (international):1-919-882-2331. For both dial-in numbers please use conference ID # 13650870.
About GW Pharmaceuticals plc
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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 30 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 glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com
Original press release: http://ir.gwpharm.com/releasedetail.cfm?ReleaseID=1002545
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