GWP, Full Bullish Broker Note......3 Oct 2016 11:35
Further to excellent research on GWP these last few days I got in touch with my broker and asked if they had a broker note on last weeks trial results, they said indeed we have and its a cracker............they say Morgan Stanley are a Giant Bull on the stock.
<b><u>Morgan Stanley</u></b>
<b><i>Second LGS trial succeeds, with Epidiolex showing similar efficacy to the first
LGS trial. Yesterday, GW Pharma reported results from the second Phase 3
study of Epidiolex in Lennox-Gastaut Syndrome (LGS). The patients enrolled in
the trial had highly refractory disease, taking an average of three anti-epileptic
drugs (AEDs) concurrently, and having failed 7 previously. These patients had a
baseline seizure frequency of 85/month. During the treatment period, patients
taking Epidiolex 20mg/kg per day (n=76) on top of their current therapy achieved
a median reduction in monthly drop seizures of 42% compared with a reduction
of 17% in patients taking placebo (n=76), resulting in a 25% statistically significant
treatment effect (p=0.0047). Patients taking Epidiolex 10mg/kg per day (n=73)
achieved a median reduction in monthly drop seizures of 37% compared with a
reduction of 17% in patients taking placebo, a statistically significant treatment
effect of 20% (p=0.0016). As a reminder, Epidiolex demonstrated a reduction in
drop seizures of 44% vs. 22% for placebo in the first Phase 3 LGS study reported
in June.
Safety for Epidiolex appears consistent with prior trials and the ongoing
expanded access program. AEs were recorded in 84% of patients treated at
10mg/kg (89% of which were mild/moderate), 94% of patients in the 20mg/kg
group (88% mild/moderate), and 72% of placebo patients. The most common
(greater than 10%) AEs across dose groups included somnolence, decreased appetite,
diarrhea, and upper respiratory tract infection. Additionally, in the 20mg/kg
group there were common reports of pyrexia, vomiting and nasopharyngitis. One
potential concern is the status epilepticus experienced by at least 10% of
patients in the 10mg/kg group. Although no cases of status epilepticus were
deemed treatment related, we continue to monitor these developments. SAEs
were found in 13 patients in the 10mg/kg group (2 treatment related), 13 patients
in the 20mg/kg group (5 treatment related) and 8 patients receiving placebo.
There was one discontinuation due to AEs in the 10mg/kg group, 6 in the
20mg/kg group and one in placebo. No deaths occurred during the study, and
99% of completers opted into an open label extension trial.
Updating our model to reflect incremental de-risking; increasing our probability
of success for Epidiolex to 85% in Dravet and LGS, and our PT to $160. Given
the positive data from the second Phase 3 study in LGS, we have increased our
probability of success (POS) for Epidiolex in both LGS and Dravet Syndrome to
85%, increased our POS in tuberous sclerosis complex (TSC) to 65
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