A	B	C	D	E	F	G
1	Main
2		Brand Name	Effient, fka CS-747
3		Generic Name	Prasugrel
4		Timeline	Study completes in Mid 2007? Data likely to be released in late 2007. (delayed from late 2006). MAA approved 4/09.
5		Mechanism	Develop drug as superior to Plavix regardless of Plavix IP
6			Thienopyridine class of ADP receptor inhibitors (on P2Y12 receptor), like ticlopidine and clopidogrel.
7			Plavix is metabolized slowly, so giving it at 3 hours puts it at a disadvantage. Prasugrel works within 30 minutes.
8			Mechanism may suggest that prasugrel avoids the 30% non-responder rate seen with Plavix.
9			Prasugrel is a prodrug like Plavix, but only requires one step versus two for Plavix.
10		Economics	US/UK 50-50 with royalty to Daiichi Sankyo in other territories
11		Commentary	"Cost is a big issue".
12		Rx		Effient	Plavix	Market	Share
13			12/18/2009	2962	686130	689092	0.004298410081672694
14			12/11/2009	2684	691185	693869	0.003868165316507871
15			12/4/2009	2430	775061	777491	0.003125438107965237
16			11/27/2009	2089	601931	604020	0.00345849475182941
17			11/20/2009	2166	672605	674771	0.003209977903614708
18			11/13/2009	1800	680955	682755	0.00263637761715403
19			11/6/2009	1808	726294	728102	0.002483168567041431
20			10/30/2009	1550	687653	689203	0.002248974540157254
21
22		Price	$5.36/day.
23		Clinical Trials
24			result from p2 cross-over study at ACC in March 2005
25			Lower dose (5mg) studies to begin?
26
27			TIMI-38 (TRITON) study, n=13614, head-to-head vs. Plavix in ACS undergoing PCI - Results November 4 expectation
28			700-800 sites, started enrolling Nov 1st 2005, finished enrolling Jan 2007. Study completes July 2007. 12 month followup.
29			PE is composite 30-day MACE. Study ends after 875 events and 6 months past last patient enrolled. Event rate has been lower than expected.
30			Results: Lowered stent thrombosis by 52%. Lowered primary endpoint 19% vs Plavix.
31			Docs think 10-15% improvement for Prasugrel with better PK.
32			Data to be presented at AHA 2007/ACC 2008.
33			SNY R&D Head notes favorable prasugrel design: lower Plavix loading dose, randomization 3 hours ahead of PCI vs 6 hours (optimal).
34			300mg loading dose for Plavix is suboptimal as many physicians use 600mg. Label indicates 300mg.
35			Enrollment criteria different from JUMBO. TRITON includes only UA/NSTEMI with TIMI>3. JUMBO TIMI mean was 2-2.5.
36			Recurrent event sub-analysis and ESC 2008 data are forthcoming. 52% reduction in stent-thrombosis.
37
38			JUMBO Phase II
39			n=900 presented at ESC 2004 showed non-inferiority to Plavix
40			Subset analysis of patients on 40mg loading dose with 7.5mg maintenance, 60/10mg or 60/15mg.
41			at 10mg/day maintenance two patients exhibited complete inhibition of collagen-induced platelet aggregation
42			Investigator expects bleeds and mortality to be higher for Prasugrel in TRITON.
43			1.7% bleeding vs 1.2% with Plavix but no risks of major bleeds.
44			9.4% MACE for Plavix, 7.2% MACE for prasugrel, p=0.30. MACE % at 30 days.
45
46			Phase III TRILOGY n=7243 unstable angina or MI without ST elevation who did not undergo revascularization
47			13.9% hit the primary endpoint of death, CV, MI, etc in prasugrel versus 16.0% in Plavix, HR=0.91, p=0.21.
48			Bleeding similar.