A	B	C
1	Main
2		Brand Name	BMS-562247
3		Generic Name	apixaban
4		Indication	Prevention of VTE.
5		Mechanism	Inhibits coagulation factor Xa
6		Competition	warfarin, JNJ/BAY's rivaroxaban, Lovenox
7		Economics	BMY partnership. Upfront payment of $250 million by Pfizer to BMS. Pfizer will fund 60% of all planned development costs effective January 1, 2007,
8			and BMS will fund the remainder. BMS may also receive additional payments of as much as $750 million based on development and regulatory milestones.
9			The companies will jointly develop the clinical and marketing strategy of apixaban, and will share commercialization expenses and profits/losses equally on a global basis.
10		History	Discovered by BMS
11		PK	Longer PK, no food effects, less drug/drug interactions.
12		Clinical Trials
13
14			Completed Phase III in Total Knee Replacement Surgery
15
16			Phase III VTE prevention in orthopedic surgery, n = 3058
17			ADVANCE-1: comparison vs Lovenox in knee replacement - FAILED
18			ADVANCE-2: comparison vs Lovenox in knee replacement, n = 3058. still recruiting, began 11/06
19			SS reduction in events with 2.5mg vs 40mg qd of Lovenox. HR=0.62, 3.5% bleeding vs 4.8% with Lovenox.
20
21			ADVANCE-3: comparison vs Lovenox in hip replacement, n = 4022. still recruiting, began 03/07
22
23			Phase III (ARISTOTLE???) vs warfarin in nonvalvular atrial fibrillation, n = 15000
24			Prevent stoke and systemic embolism
25			Still recruiting, began 12/06
26
27			Phase III prevent strokes and systemic embolisms in Atrial Fibrillation Patients, n= 5600
28			5mg BID vs Acetylsalicylic Acid (81 - 324mg QD)
29			Atrial Fibrillation Patients 50y and above who have failed or unsuitable for Vitamin K Antagonist
30			Still recruiting, began 08/07
31
32			Phase II in metastatic cancer to reduce increased risk for VTE, n = 160
33			Placebo controlled
34			Still recruiting, began 6/06
35
36			Phase II in DVT following Knee Replacement Surgery, n = 6524
37			vs. Lovenox
38			Still recruiging, began 06/07
39
40			Phase II 12-week in DVT, n=520
41			3 doses 5mg BID, 10mg BID, and 20mg once daily vs. low molecular weight heparin or fondaparinux and vitamin K.
42			Ongoing, began 11/05
43
44
45			Phase III ARISTOTLE in atrial fibrillation
46
47			Phase III ADOPT in AMI
48
49			Phase III AVERROES n=5600 vs Aspirin in Afib patients intolerant to warfarin NEJM 2011
50			Stopped early 6/2010 due to benefit.
51			1.6% events versus 3.7% events for aspirin.
52			1.4% bleeding versus 1.2% for aspirin.
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80			Phase II in recent ACS, +/- placebo, n = 1800
81			Still recruiting, began 04/06