ZLB Bioplasma BLA for Rh0 -D- Immune Globulin Accepted for Review by FDA.

Business Editors & Health/Medical Writers

GLENDALE, Calif.--(BUSINESS WIRE)--Nov. 26, 2002

ZLB Bioplasma's biologics license application (BLA) for its Rh0(D) immune globulin, with the proposed trade name Rhophylac(R), has been accepted for review by the U.S. Food and Drug Administration. ZLB Bioplasma is a major source of intravenous immunoglobulin (human) -- IVIG -- and other specialty plasma-derived products for the U.S. market.

ZLB Bioplasma's Rh0(D) immune globulin is a plasma-derived product composed of anti-D immune globulin. Its primary indication is for preventing hemolytic disease of the newborn (HDN), a serious and sometimes fatal disorder in which antibodies produced by a pregnant, Rh-negative woman attack the red blood cells of her Rh-positive fetus or newborn.

ZLB's high-capacity Rh0(D) immune globulin plant in Bern, Switzerland, uses proprietary column chromatography and two viral inactivation and removal steps, including nanofiltration, to generate highly pure anti-D immune globulin from the plasma of hyperimmune donors.

"ZLB is making an important contribution toward prevention of hemolytic disease of the newborn by providing the U.S. market with a reliable supply of safe, effective, high-quality anti-D," said Martin Rosendale, senior vice president of sales and marketing at ZLB Bioplasma. "The introduction of this product reinforces ZLB Bioplasma's commitment to providing specialty plasma-derived products to patients in the U.S."

ZLB's Rh0(D) immune globulin has been sold as Rhophylac(R) in Switzerland since 1996 and was introduced to other European markets in 2001. Pending FDA's review of the BLA, ZLB expects to make its Rh0(D) immune globulin available to U.S. patients by 2004.

About ZLB Bioplasma Inc.

ZLB companies develop, manufacture and market biopharmaceutical products derived from human plasma. ZLB Bioplasma Inc. focuses on providing immune-based therapies and services that help the healthcare community improve the quality of life for their patients. The company's products are available nationally through wholesalers, distributors and group purchasing organizations or direct from ZLB. For more information, visit www.zlbusa.com or call 866/244-2ZLB (2952).

ZLB's products, made from plasma collected from U.S. donors, are manufactured by ZLB Bioplasma AG, at its FDA-licensed facility in Bern, Switzerland. ZLB Bioplasma AG is a subsidiary of CSL Limited, a leading biotechnology and biopharmaceutical company founded in 1916 in Melbourne, Australia. CSL Limited acquired ZLB from the Swiss Red Cross in August 2000.

Note to Editors: In Rh0(D) the "0" is a subscript.