A	B	C	D	E	F	G	H	I	J	K	L
1	Main
2		Brand Name	Velcade
3		Generic Name	bortezomib
4		Mechanism	tripeptide, Proteasome Inhibitor
5		Pharmacokinetics	Peak concentration 30 mins. Drug levels cannot be measured after 1hr.
6		Administration	Injection (bolus) 2x wk for 2 wks followed by 10 day rest period.
7		Label	http://velcade.com/full_prescrib_velcade.pdf
8		Indication	Multiple Myeloma (MM) for patients who received at least one prior therapy.									http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_is_multiple_myeloma_30.asp
9			Mantle Cell Lymphoma (MCL) who have received at least one prior therapy.
10		IP	Formulation Patent expires 2022, composition patent expires 2014
11		Side Effects	Peripheral Neuropathy in 30% of the patients. High rate of shingles
12		Competition	Revlimid (CELG), Thalomid (CELG)
13		Economics	JNJ / MLNM partnerhsip? EU forever, what about US (commission?) will takeda renew?
14		Clinical Studies
15			Phase III - Open label, relapsed Multiple Myeloma, velcade vs dexamethosone - study stopped early in favor of velcade
16			Median TTP - 6.2 mo vs 3.5 mo for dex (primary endpoint)
17			ORR 38% vs 18% for dex
18			Median number of prior lines of therapy = 2 for both groups, all patients received steroids previously
19
20		`	Enter Revlimid data from CELG
21
22			Phase III Apex - treatment in patients with relapse?
23			Equally effected in younger and elderly?
24			Adverse incidents comparable across groups
25
26			Phase III VISTA (1) study - January 2005 - newly diagnosed patients, n=682
27			Untreated patients that were not eligible for Stem cell transplantation (SCT)
28			Finish - http://investor.millennium.com/phoenix.zhtml?c=80159&p=irol-newsmediaArticle&ID=1085399&highlight=
29
30
31
32
33			Phase IV Everest Study - asses M-protein response in patients who previously responded to velcade and relapsed following a treatment free remission
34
35
36
37
38
39
40		Other	Mantle Cell Lymphoma International Prognostic Index (MIPI)
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42
43
44
45			2004	2005	2006	2007	2008
46		OUS	#ERROR_#REF!	#ERROR_#REF!