GW Pharma: Capitalizing On Cannabis Science
Alan Brochstein, CFA • 92 Comments
Alan Brochstein, CFA • 92 Comments
Tue, Jul. 12, 5:39 PM
- GW Pharmaceuticals (NASDAQ:GWPH) announces its plan to sell $150M of American Depositary Shares (ADSs) in a U.S. public offering. Underwriters over-allotment will be an additional $22.5M of ADSs. Price and terms have yet to be announced.
- Shares are down 3% after hours on modest volume.
- Update: On July 13, the company announced that the offering is 2.8M ADSs at $90 per ADS generating gross proceeds of $252M. Each ADS represents 12 ordinary shares. Underwriters over-allotment is an additional 420K ADSs. Closing date is July 18. Shares are down 6% on more than triple normal volume.
- Update: On July 18, GW announced that it raised $289.8M. The underwriters over-allotment was fully exercised.
Tue, Jul. 12, 5:36 PM
Mon, Jun. 27, 9:13 AM
Mon, Jun. 27, 8:14 AM
- GW Pharmaceuticals (NASDAQ:GWPH) is up 18% premarket on robust volume in response to its announcement of positive top-line data from a Phase 3 clinical trial assessing lead product candidate, Orphan Drug-tagged Epidiolex (cannabidiol), for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.
- The study achieved its primary endpoint of a statistically valid reduction in the monthly frequency of drop seizures over the 14-week treatment period compared to placebo (p=0.0135).
- The trial randomized 171 LGS patients 1:1 to receive either 20 mg/kg/day of Epidiolex (n=86) or placebo (n=85) added to their current anti-epileptic drug treatment. The median baseline drop seizure frequency per month was 74, which was reduced 44% in the Epidiolex arm compared to a 22% reduction for placebo. Drop seizures were defined as atonic (brief lapse in muscle tone), tonic (body stiffens) and tonic-clonic (muscles stiffen accompanied by jerky movements) seizures involving the entire body, trunk or head that led or could have led to a fall, injury, slumping in a chair or hitting the patient's head on a surface.
- CEO Justin Glover says, "We are delighted to announce positive results in this Phase 3 trial of Epidiolex in patients with Lennox-Gastaut syndrome, and particularly pleased that this result is consistent with our recent Phase 3 pivotal data for Epidiolex in Dravet syndrome. We now look forward to advancing Epidiolex towards the submission of an NDA with the FDA in the first half of 2017."
- Full results will be presented at future medical conferences and will be submitted for publication.
- Results from a second Phase 3 study in LGS should be released in Q3.
Tue, Jun. 21, 8:18 AM
- GW Pharmaceuticals (NASDAQ:GWPH) edges up 3% premarket on light volume in response to its announcement that it has formalized a fourth target indication, infantile spasms (IS), for lead product candidate Epidiolex (cannabidiol). The FDA has designated Epidiolex an Orphan Drug for the treatment of IS. A two-part Phase 3 study should commence in Q4.
- IS is an epilepsy-type of seizure in infancy and childhood known as West syndrome. The condition constitutes 2% of childhood epilepsy cases. It affects 2K - 4K American kids each year. The long-term prognosis is poor.
- Epidiolex is currently under development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex.
Tue, May 31, 5:37 PM
Thu, May 5, 10:04 AM
Wed, Mar. 16, 12:50 PM
Mon, Mar. 14, 12:45 PM
Mon, Mar. 14, 9:17 AM
Mon, Mar. 14, 8:34 AM
- Thinly traded nano cap Zynerba Pharmaceuticals (NASDAQ:ZYNE) is up 66% premarket on average volume in connection with the bullish action related to GW Pharmaceuticals' (NASDAQ:GWPH) successful Epidiolex (cannabidiol) study results. Zynerba's lead product candidate is Orphan Drug-tagged ZYN002, a synthetic cannabidiol formulated as a gel for transdermal delivery for the treatment of Fragile X syndrome, an inherited disorder characterized by learning disabilities and cognitive impairment.
- Previously: Zynerba's cannabidiol gel an Orphan Drug for Fragile X syndrome (Feb. 25)
- Previously: GW Pharma's Epidiolex successful in late-stage study in rare form of epilepsy; shares up 127% premarket (March 14)
Mon, Mar. 14, 8:17 AM
- Small cap GW Pharmaceuticals (NASDAQ:GWPH) is up a whopping 127% premarket on robust volume in response to its announcement of positive results in a Phase 3 clinical trial assessing Orphan Drug- and Fast Track-tagged Epidiolex (cannabidiol) for the treatment of Dravet syndrome, a rare and catastrophic form of childhood epilepsy for which there are no approved treatments. The study met its primary endpoint of a statistically valid reduction in convulsive seizures over the 14-week treatment period compared to placebo.
- The 120-subject study compared 20 mg/kg/day of Epidiolex (n=61) to placebo (n=59). On average, patients were receiving 3 anti-epileptic drugs (AEDs), having tried and failed an average of four other AEDs. Median baseline convulsive seizure frequency was 13/month. Patients receiving Epidiolex experienced a 39% reduction in monthly convulsive seizures versus 13% for placebo (p=0.01). The superiority of Epidiolex was observed in the first month of treatment and was sustained throughout the 14 weeks.
- Epidiolex was generally well-tolerated in the trial. The most common adverse events (>10%) were somnolence (drowsiness), diarrhea, decreased appetite, fatigue, pyrexia (elevated body temperature), vomiting, lethargy, upper respiratory tract infection and convulsion. 84% of the AEs were mild or moderate. Ten patients Epidiolex patients experienced a serious adverse event compared to three for placebo. Eight Epidiolex patients discontinued treatment due to AEs versus one for placebo. The data will be presented at future medical meetings and will be submitted for publication.
- The company plans to hold a pre-NDA meeting with the FDA as soon as feasible to discuss its regulatory submission, expected by mid-year.
- A second pivotal study in Dravet in ongoing as well as two Phase 3s in Lennox-Gastaut syndrome, another form of severe childhood epilepsy.
- Dravet-related tickers: (NASDAQ:ZGNX)(NASDAQ:INSY)
Mon, Jan. 11, 5:38 PM
Dec. 24, 2015, 9:17 AM
- GW Pharmaceuticals (NASDAQ:GWPH) is up 5% premarket on light volume in response to the news that the results from a physician-led expanded access program in patients with treatment-resistant epilepsy who received Epidiolex (cannabidiol) were just published in The Lancet Neurology.
- Epidiolex, as an add-on treatment, reduced the frequency of seizures across multiple drug-resistant epilepsy syndromes and seizure types while being generally well-tolerated (3% therapy termination rate).
- The expanded access program was a "compassionate access" initiative carried out by individual investigators not affiliated with the company. Enrolled patients were some of the most treatment-resistant under care at each of the medical centers.
- 162 patients who had at least 12 weeks of follow up after the first dose of Epidiolex were included in the safety and tolerability analysis and 137 were included in the efficacy analysis. The group of 162 included 33 patients with Dravet syndrome (DS) and 31 with Lennox-Gastaut syndrome (LGS), two rare debilitating forms of epilepsy.
- DS patients treated with Epidiolex showed a median reduction in monthly motor seizures of 49.8% with half experiencing at least a 50% reduction. Four were seizure-free. In those who had seizures at baseline, the median reductions in tonic seizures and non-motor focal seizures were 69.2% (n=6) and 83.3% (n=10), respectively.
- LGS patients receiving Epidiolex showed a median reduction of 68.8% (n=14) in average monthly atonic seizures. During the four weeks of therapy, 21% (n=3) were free of atonic seizures while one patient was totally seizure free.
- Adverse events (AEs) occurred in 79% (n=128) of all patients treated with Epidiolex. The most common AEs were drowsiness (25%), decreased appetite (19%), diarrhea (19%), fatigue (13%) and convulsion (11%). Most were mild or moderate and transient.
- Top-line results from two ongoing Phase 3 studies in DS are expected in Q1 and mid-year, respectively. Top-line data from two LGS studies are expected in Q2.
Dec. 24, 2015, 9:13 AM
Dec. 8, 2015, 5:37 PM
GW Pharmaceuticals Plc engages in the business of discovering, developing and commercializing novel therapeutics from proprietary cannabinoid product platform in a broad range of disease areas. The company operates through the following segments: Commercial, Sativex Research & Development and... More
Industry: Drug Manufacturers - Other
Country: United Kingdom
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