Eculizumab information from Joan - thank you, Joan!

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Eculizumab (ion).

Kaplan M.

Curr Opin Investig Drugs. 2002 Jul;3(7):1017-23.

University of Michigan Medical Center, Division of Rheumatology,

Ann Arbor 48109-1065,USA makaplan@...

Eculizumab (5G1.1), a humanized monoclonal antibody that prevents the

cleavage of human complement component C5 into its pro-inflammatory

components, is under development by ion as a potential treatment

for several chronic inflammatory diseases, including rheumatoid

arthritis (RA) and nephritis [190673], [292328].

In January 2002, a phase IIb trial was initiated for RA [437814].

This trial was ongoing in April 2002, at which time, eculizumab was

also in phase II trials for the treatment of membranous nephritis and

lupus nephritis, and in earlier stage clinical trials for dermato-

myositis and pemphigoid [446377].

The company is also developing a single-chain version of this

antibody, pexelizumab, for use in acute cardiovascular indications

[188760]. In October 2000, eculizumab was granted Orphan Drug status

by the FDA for the treatment of dermatomyositis [385057]. In February

2002, the product received Orphan Drug designation for its use in

patients with membranous nephritis [440583].

In September 2001, analysts at US Bancorp Piper Jaffray predicted

eculizumab's launch for dermatomyositis and pemphigus in 2003, RA and

nephritis in 2004, and chronic heart failure (CHF) after 2006 [426537].

In March 2002, analysts at US Bancorp Piper Jaffray predicted that the

product would have peak worldwide sales in RA of US $175 million and

US $400 million for nephritis. Sales for the RA indication are

predicted to reach US $35 million in 2006, rising to US $110 million

in 2008, and US $10 million in 2006, rising to US $50 million in 2008,

in the US and the rest of the world, respectively. For the nephritis/

other indication(s), sales are pegged at US $50 million in 2006, rising

to US $200 million in 2008, and US $15 million in 2006, rising to

US $100 million in 2008, again in the US and the rest of the world,

respectively [446992].