A	B	C
1	Main
2		Brand Name	Arzerra, fka HuMax-cd20
3		Generic Name	ofatumumab
4		Indication	CLL, NHL, Multiple Sclerosis, Rheumatoid Arthritis
5		Economics	Genmab partnership, renegotiated in 2010 to allow GSK to develop autoimmune indications.
6		Molecule	Fully human antibody to new epitope.
7		Administration	Subcutaneous delivery for autoimmune indications, intravenous for oncology indications.
8		Timeline	4/19/10 EMEA approval.
9			1/22/10 CHMP positive opinion.
10			10/26/09 FDA approval.
11			5/29/09 ODAC positive vote.
12		Clinical Trials
13			Phase III Rituxan-Failure indolent B-NHL
14			Compares Bendamustine+-Arzerra. Primary endpoint PFS.
15
16
17			Phase III Pivotal CLL study n=95 3L
18			Fludarabine/Alemtuzumab refractory CLL
19			n=59 interim resulted in worldwide approval
20			ORR 51%
21
22
23			Phase III Rheumatoid Arthritis study using IV
24			50% response rate versus 27% for placebo.