A	B	C
1	Main
2		Brand Name	Praluent
3		Generic Name	REGN727
4		Mechanism	fully human monoclonal antibody against PCSK9 antibody (proprotein convertase subtilisin/kexin type 9)
5		Indication	reduce LDL
6		Competition	statins
7		Economics	Sanofi
8		Administration	IV, SC
9		Clinical Trials
10			Phase 2 in hypercholesterolemia pts in combo w statin tx -- started in early 2011
11
12
13			Phase 1 in healthy volunteers -- May 2010 announced interim analyses of Ph1 healthy volunteer study
14			dose-escalating, randomized, double-blind, each dosing cohort consisted of 6 tx and 2 placebo pts
15			July 2010 further data presented
16			at highest IV dose, single dose achieved >60% max mean reduction of LDL fr baseline that lasted for >1 mo
17			at highest SC dose, single dose achieved >60% mas mean reduction of LDL fr baseline that lasted for >2 wks
18
19			Phase 1 in hyperlipidemic pts (familial & non-familial hypercholesterolemia) -- July 2010 interim analyses
20			dose-escalating, randomized, double-blind, on pts on stalbe doses of statins whose LDL levels were >100 mg/dL
21			at highest dose tested (at the time), in 11 pts, a single dose achieved ~40% max mean add'l reduction of LDL fr baseline