A	B	C
1	Main
2		Brand Name	Intelence, fka TMC125
3		Generic Name	etravirine
4		Mechanism	NNRTI with improved resistance and safety.
5		Administration	Oral BID
6		Indication	HIV
7		IP	de novo by Tibotec.
8		PK	Drug-drug interaction?
9		Side Effects	Diarrhea and rash.
10		Timeline	Filed in Q307, assume priority review and approval in Q108.
11		Projections	Sustiva generated $800m in sales in 2006 and is expected to generate $900m in sales in 2007.
12		Clinical Studies
13			TMC125-C223: p2b in n=199 tx-experienced patients.
14			-1.04/-1.18 vs -0.19 for 400mg/800mg vs control groups.
15			48-week data showed 98% of control patients had discontinued by 48 weeks vs 38% of TMC125 patients.
16			Week 48 viral load: -0.88, -1.01 and -0.14 in 400mg 800mg and control.
17			31%, 34% and 8% achieved 1 log or greater reduction in viral load at 48 weeks
18
19			DUET-1, DUET-2 phase III
20			2 n=600 pivotal studies in tx-experienced patients began in November 2005. PI agent will be TMC114.
21			NS for cd4?
22
23
24			c227 - stopped early by dsmb?