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ZymoGenetics and Merck Serono Receive FDA Special Protocol Assessment for Atacicept Pivotal Study in Lupus Nephritis
Date:10/4/2007

ients with general systemic lupus erythematosus, for which the SPA review process is ongoing.

About Lupus Nephritis

Lupus nephritis is a complication of systemic lupus erythematosus(SLE) and is characterized by inflammation of the kidneys. Patients with lupus nephritis typically have damage to the glomerulus and progressive loss of kidney function. In the U.S., SLE affects 1 person in 2000, with higher rates among women and among individuals with African, Asian, and Hispanic genetic heritage. Published studies estimate that clinical renal involvement occurs in at least 30% of those with SLE.

About Atacicept

ZymoGenetics and Merck Serono, an affiliate of Merck KGaA, Darmstadt, Germany, are developing atacicept (formerly referred to as TACI-Ig) for the treatment of autoimmune diseases and B-cell malignancies. Atacicept contains the soluble TACI receptor that binds to the cytokines BLyS and APRIL. These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases such as SLE. Current data indicates that levels of BLyS and APRIL are elevated in patients with rheumatoid arthritis, SLE and B-cell malignancies. Atacicept has been shown to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies.

About ZymoGenetics

ZymoGenetics creates novel protein drugs with the potential to significantly help patients fight their diseases. The Company is developing a diverse pipeline of product candidates that are moving into and through clinical development. These candidates span a wide array of clinical opportunities that include bleeding, autoimmune diseases and cancer. ZymoGenetics intends to commercialize these product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit

SOURCE ZymoGenetics, Inc.
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