Biotest receives FDA approval for BIVIGAM to treat primary humoral immunodeficiency

Biotest Pharmaceuticals CorporationDec 20 2012

Biotest AG announced today that Biotest Pharmaceuticals Corporation received approval for BIVIGAM™ for the treatment of patients with Primary Humoral Immunodeficiency (PI) from the U.S. Food and Drug Administration (FDA). BIVIGAM is the first polyspecific intravenous immune globulin manufactured in the U.S. by Biotest Pharmaceuticals Corporation (BPC) at its Boca Raton, Florida facility. This product is being produced for patients in the United States, and the company plans to begin commercial shipments shortly.

Prof. Dr. Gregor Schulz , CEO of Biotest AG, said: "Biotest has made a significant commitment in the U.S. to bring a new immune globulin to individuals with primary immunodeficiency. We have invested over $50 million to create a state-of-the-art facility and have expanded our U.S. capabilities from plasma collection to protein purification and product distribution. BPC will eventually produce up to 1.5 million gramss long legacy of providing immune globulin products to patients around the globe."

The U.S. IVIG market is the largest in the world and Biotest's entry into this market fulfills the company's longstanding vision of being a significant global participant. Biotest formed BPC as a U.S. subsidiary in 2007, with the purchase of Nabi Biopharmaceuticals' biologics strategic business unit, which included a plasma protein plant and plasma collection centers. Today's approval represents a sales potential of $100 million for BPC.

Marcia Boyle , President & Founder of the Immune Deficiency Foundation, a national patient organization for persons with primary immunodeficiency diseases, commented, "We commend Biotest for its significant commitment and investment in the development of BIVIGAM. Its launch provides a new product to our community, helping to assure continued access to this lifesaving therapy for people who live with primary immunodeficiency diseases. We welcome BIVIGAM as a valuable option to help members of our community live healthy and productive lives."

The BIVIGAM pivotal clinical study successfully achieved its primary endpoints for safety, efficacy and tolerability, and the results were recently published in the Journal of Clinical Immunology (Wassermann RL, Church JA, Stein M, et al. Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (IVIG) in patients with primary immunodeficiency. Journal of Clinical Immunology).

BIVIGAM is a sugar-free, glycine stabilized intravenous immune globulin that was approved by the FDA December 19, 2012 and is available in 50 mL (5 gram) and 100 mL (10 gram) tamper-evident vials. The product uses a label with an integrated hanger and the packaging material is latex free. For Full Prescribing Information and more information about the product, the indication and additional services, please visit www.BIVIGAM.com.