A	B	C	D	E	F	G	H	I	J	K	L	M	N	O
1	Main
2		Brand Name	Olumiant, fka LY3009104/INCB28050
3		Generic Name	baricitinib
4		Indication	Rheumatoid arthritis, Alopecia Areata
5		Mechanism	JAK1/2 inhibitor
6		Administration	Oral
7		Competition	RIGL, CHTP(?)
8		Economics	LLY, $139 million in milestones received to date
9			INCY could receive tiered double digit royalties.
10			INCY will pay for 30% of development expenses
11		IP	INCY discloses patent protection until 2026, but has not disclose structure or patent #.
12		Clinical Trials
13			Phase III "BRAVE-AA1"
14			17%-22% with 2mg qd and 32-35% with 4mg qd achieved 80% or more scalp hair coverage vs. 3-5% for placebo at 36 weeks.
15
16
17			Phase III "BRAVE-AA2"
18
19			Phase III "BREEZE-AD"
20
21
22			Phase IIb, n = 270
23			Primary endpoint is ACR20 at 12 weeks												Pfizer's CP-690,550 Phase IIa data
24			Fully enrolled as of October 27, 2011
25			Dosing is 1,2,4,8 mg 9104 compared to PBO
26
27			Phase IIa, n = 125
28
29			mITT total population, 12 week result
30				PBO	4 mg	7 mg	10 mg
31				n = 31	n = 31	n = 32	n = 30
32			ACR20	0.32	0.52	0.59	0.53
33			ACR50	0.13	0.35	0.31	0.3
34			ACR70	0.03	0.16	0.09	0.1
35
36			No major Aes. There were dose related decreases in mean hemoglobin of 2 to 8%.
37
38			ACR2010
39			Ph2a, n=125, to receive 4mg qd, 7mg qd or 10mg qd
40			primary endpt: % of pts achieving ACR20 thruout 24 Wks
41			ACR responses improved over wks 12-24, w up to 72% of pts ACR20, 44% ACR50 & 30% ACR70 at Wk 24												CP-690,550 Phase IIb 24-week data
42			placebo pts: 32% ACR20, 13% ACR50 & 3% ACR70 at Wk 12												12-week interim data at ACR 2008 suggests activity. 3mg active. 6 doses tested.
43			INCB28050 pts: 59% ACR20, 35% ACR50 & 16% ACR70												5 cases of liver tox at 15mg BID.
44
45			Phase III "ACTT-2" n=1033 COVID-19
46			bari+remdesivir vs. remdesivir
47
48
49			Phase III "COV-BARRIER" n=1525 COVID-19