A	B	C
1	Main
2		Brand Name	Sprycel, BMS-354825
3		Generic Name	dasatinib
4		Indication	Gleevec-resistant/intolerant CML - approved
5		Competition	Tasigna: Sprycel likely more effective but less tolerable.
6		Dosage	50mg or 70mg BID, 100mg or 140mg QD
7		Safety	Pleural Effusion
8		IP	NCE.
9		Price	$47k based on 70mg bid/140mg qd. 30% higher in EU.
10
11			Phase III DASISION vs Gleevec in newly diagnosed Chronic Phase CML
12			Superior MMR/cytogenetic response. 77% vs 66%.
13
14			p2 START trial in Glivec-refractory CML- ASH 2005
15			Glivec-resistant CML and Ph+ ALL patients
16			grade 3/4 myelosuppression and pleural effusion
17			28-52% of patients had dose reductions
18
19			START-C: Chronic CML Patients who have failed Gleevec - Updated at ASH 2006
20			40% complete cytogenic response for patients who are Gleevec-refractory
21			90% CHR and 51% MCyR vs 90%/45% at ASH
22			17% pleural effusion, 33% GI. 63% had dose interruptions
23
24			START-R (CA180-017): Sprycel vs Higher-Dose Imatinib in Chronic Phase CML patients resistant to Imatinib.
25			head-to-head against 800mg Gleevec in patients who have failed low-dose - data at ASH 2007??? - p2/3??
26			35% response vs 29% for Gleevec. Complete repsonse 21% vs 8%
27			18% discontinued Gleevec vs 7% for Sprycel
28
29			6/7/2006 - BOFA estimates 525m in 2010
30
31			Gleevec IRIS showed 83% of patients on low-dose Gleevec remain stable after 5 years.
32
33			CML/Ph+ALL is 4,800 patients/year. Bear says 45% become resistant. Assume 50k cost of therapy.
34			combo with Gleevec might be useful
35			AMN-107 is competition
36
37			1L CML p2 single-arm study ongoing with larger SWOG trial vs gleevec being planned. 1L data at ASCO 2007?
38			AMN-107 TOP study suspended following 6 deaths
39
40			CA180031 - Japan Phase I/II in CML-Resistant/Intolerant to Imatinib patients.
41
42			CA180018 Phase I/II Children/Adolescent R/R Leukemia
43
44			CA180-005 START-A Phase II: Patients with CML in Accelerated Phaes that is Imatinib-Resistant or Intolerant
45
46			Sprycel in pts with Previously Untreated CML in Chronic Phase
47
48			CA180-034 - Sprycel in CML in Chronic Phase Resistant or Intolerant to Imatinib
49
50			START-L: CA180-015: Sprycel in PH+ ALL who are Imatinib Resistant or Intolerant.
51
52			Sprycel in patients who are in Lymphoid or Myeloid Blast Phase of CML and are Imatinib-Resistant or Intolerant
53
54			CA-180-035: Sprycel 140mg QD vs 70mg BID in Advanced Phase CML or Ph+ ALL who are resistant or intolerant to Imatinib
55
56
57			Phase II prostate study - data available ASCO 2008
58			Potential competition to CGRB MDVN etc?