A	B	C	D	E	F	G	H	I	J	K	L	M	N	O	P	Q	R	S
1	Main
2		Brand Name	Simponi fka CNTO 148
3		Generic Name	golimumab
4		Indication	Approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
5		Dosing	50mg SC QM (Humira q2w, Enbrel qw). IV coming?
6		IP	NCE? 7,521,206 issued in 2009. ABT suing over 7223394.
7		Mechanism	Human IGG1 MAB to TNF-alpha. Multiple glycoforms result in weight of 150-151 kD. Binds to soluble and transmembrane TNFa, but does not bind lymphotoxin.
8		PK	Tmax 2-6 days. Cmax 2.5ug/mL. Limited extravascular distribution. Terminal 1/2 of 2 weeks. Absolute F of 53%. Steady-state at 12 weeks.
9		Side Effects	Tubercluosis reactivation (0.23/100 patient years incidence in n=2347 phase II/III experience), lymphoma (0.21/100 patient years). Less dropouts than placebo in Phase III experience.
10		Timeline	Approved in the US 4/29/09. Submitted MAA in March 2008. Positive CHMP opinion June 2009.
11		Papers	Pharmacokinetics and Safety of Golimumab, a Fully Human Anti-TNF-alpha Monoclonal Antibody, in subjects with Rheumatoid Arthritis. Zhou et al. J Clin Pharm 2007;47:383-396.
12		Economics	SGP partner? MEDX.
13		Clinical Studies
14			Phase III "T05, RA-3" - n=637 - RA naïve to methotrexate - "GO-BEFORE" - EULAR 2008
15			MTX alone vs 50mg+MTX vs 100mg+MTX vs 100mg monotherapy. ACR50 at week 24 was the primary endpoint.
16			50mg missed S.S.: 36% ACR50 for goli+MTX vs 29% for MTX.
17			ACR 20% at week 24 was 52% for monotherapy, 49% for MTX monotherapy, 62% for combination.
18			ACR 50% at week 24 was 29% for MTX and 40% for combination.
19			ACR 70% at week 24 was 16% for MTX and 24% for combination.
20
21			Phase III "T06, RA-2, GO-FORWARD" - n=444 - RA active despite MTX - Keystone et al, Ann Rheum Dis 2009 June;68(6):789-96.
22			50mg, 100mg and placebo all with background MTX, or 100mg monotherapy. ACR20 at week 14 was the primary endpoint.
23			ACR 20 at week 24 for 50mg+MTX was 60% vs 28% for MTX alone (55% and 33% at week 14).
24			ACR 50 at week 24 for 50mg+MTX was 37% vs 14% for MTX alone (35% and 10% at week 14).
25			ACR 70 at week 24 for 50mg+MTX was 20% vs 5% for MTX alone (13% and 4% at week 14).
26
27			Phase III "T11, RA-1" - n=461 - TNF-refractory
28			50mg, 100mg and placebo. ACR at week 14 was the primary endpoint.
29			ACR 20 at week 24 for 50mg+MTX was 34% vs 17% for MTX alone (35% and 18% at week 14).
30			ACR 50 at week 24 for 50mg+MTX was 18% vs 5% for MTX alone (16% and 6% at week 14).
31			ACR 70 at week 24 for 50mg+MTX was 12% and 3% for MTX alone (10% and 2% at week 14).
32
33			Phase III "T08" - n=405 - Psoriatic Arthritis
34			ACR20 at week 24 for 50mg+MTX was 52% vs 12% for MTX alone (51% vs 9% at week 14).
35			ACR50 at week 24 for 50mg+MTX was 32% vs 4% for MTX alone (30% and 2% at week 14).
36			ACR70 at week 24 for 50mg+MTX was 19% vs 1% for MTX alone (12% vs 1% at week 14).
37
38			Phase III "T09" - n=356 - Ankylosing spondylitis
39			ASAS response of 59% for 50mg+DMARDS vs 22% for DMARDS alone at week 14.
40
41			Phase II - Rheumatoid Arthritis - Published in Arthritis & Rheumatism 2006: 54(9);S833. Kay J et al.
42			p2 RA - 62% of goli+MTX had ACR20 at week 16 vs 37% for MTX alone. 31% ACR50, 12% ACR70 (6% and 0% for placebo). 25% achieved remission evaluated by DAS28.
43
44			Phase II asthma n=309
45			Study terminated due to 1 death and 8 malignancies. No efficacy seen at 24 weeks.
46
47			Phase II Crohn's
48			Doing second phase 2 to identify dose, prioritization is low.
49
50
51		Rx										Simponi		Cimzia		Enbrel		Humira
52				Simponi	Enbrel	Humira	Cimzia	NRX	TRX			NRX	TRX	NRX	TRX	NRX	TRX	NRX	TRX
53			9/4/2009					485	972		August	2128	3798	2706	4558	47515	151017	39653	117098
54			8/28/2009	0.025	0.502	0.417	0.033	547	1016		July	2220	3169	1460	2407	48809	159874	39453	121735
55			8/21/2009	0.021	0.519	0.414	0.027	464	833		June	1717	1897	1237	2093	53075	164574	42789	123268
56			8/14/2009	0.021	0.502	0.429	0.029
57			8/7/2009	0.024	0.497	0.431	0.027
58			7/31/2009	0.021	0.528	0.413	0.016
59			7/24/2009
60			7/17/2009
61			7/10/2009
62			7/3/2009