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COWEN COLLABORATIVE INSIGHTS February 25, 2019 Figure 121 Efficacy Results From Epidiolex’s First Phase Ill Trial In Dravet Syndrome A| Convulsive Seizures B| Total Seizures CBD (n-61) @ CBD (n-61) @ Placebo (n=59) Bi Placebo (n=59) 50 50 45 p-0.0123 45 < = 40 p=0.0234 = = 35 o 3 3S 30 Qo oO 4 & 5. x 3 5 § 20 3 B ob = = 10 5 ° Treatment Period Maintenance Period Treatment Period Maintenance Period (Primary) Source: GW Pharma, AES 2016 The most common adverse events were reported to be somnolence (36% in patients on Epidiolex vs. 10% in placebo patients), diarrhea (31% vs. 10%), decreased appetite (28% vs. 5%), fatigue (20% vs. 3%), pyrexia (15% vs. 9%), and vomiting (15% vs. 5%). Importantly, there was no difference in the number of patients who experienced status epilepticus between Epidiolex (n=4) and placebo (n=3). Increases in ALT or AST (>3x ULN) occurred in 12 CBD and 1 placebo patient, all of whom were on concomitant valproic acid. All elevations resolved. SAEs were seen in 10 Epidiolex patients vs. three on placebo. Eight patients on Epidiolex discontinued treatment compared with one patient on placebo, due to adverse events similar to those above, including three due to ALT/AST elevations. Figure 122 Safety Data From Epidiolex’s First Phase III Trial In Dravet Syndrome ‘CBD (n=61) Placebo (n=59) n(%) n(%) All-causality TEAES 57 (83.4%) 44 (74.6%) Treatment-related TEAEs 43(70.5%) 16 (27.1%) TEAEs leading to withdrawal 9(14.8%) 1(1L.7%) Serious TEAES 10(16.4%) 3(5.1%) Treatment-related serious TEAES 5 (8.2%) ie) TEAEs reported in >10% of patients in either group by preferred term Somnolence 22 (36.1%) 6(10.2%) Diarrhea 19(31.1%) 6 (10.2%) Decreased appetite 17 (27.9%) 3(5.1%) Fatigue 12(19.7%) 2(34%) Pyrexia 9(14.8%) 5 (8.5%) Vomiting 9(14.8%) 3 (5.1%) Lethargy (13.1%) 3(5.1%) Upper respiratory tract infection 7 (11.5%) 5 (8.5%) Convulsion 7 (11.5%) 3(5.1%) Source: Cowen and Company In 2015, GW initiated two Phase Ill trials in Lennox-Gastaut Syndrome. The first trial enrolled 171 patients, and the second enrolled 225. In the first LGS study, the patients were randomized 1:1 to 20mg/kg or placebo while in the second, they were randomized 1:1:1 to 20mg/kg Epidiolex, 10mg/kg Epidiolex, or placebo. The LGS trials assessed drop seizures (atonic, tonic, and tonic-clonic seizures that involve 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 88 COWEN.COM HOUSE_OVERSIGHT_024904