Bayer HealthCare LLC, Biological Products Division announced that the U.S. Patent and Trademark Office has registered its trademark for Gamunex, its next-generation intravenous immunoglobulin (IGIV) treatment, currently under review by the U.S. Food and Drug Administration (FDA) and other global regulatory authorities. U.S. trademark registration is another important milestone in the global branding of Gamunex.

Bayer BP has been a longtime leader in immunoglobulin therapy, dedicated to refining production methods and committed to leading the market in process enhancements resulting in improved IGIV treatments for patients. The company has produced a series of IGIV firsts, including the first IGIV preparation in the U.S. market in 1981; the first liquid, 5% "ready-to-use" product, Gamimune N 5%, Immune Globulin Intravenous (Human) 5% in 1986; and, in 1992, the first highly concentrated, 10% "ready to use" formulation, Gamimune N 10%, Immune Globulin Intravenous (Human) 10%. Bayer BP's successor to Gamimune N -- Gamunex -- continues this tradition of firsts.

Bayer BP scientists have developed an innovative production process for Gamunex, utilizing caprylate as an effective and safe alternative to solvent-detergent (S/D) treatment for inactivating and removing enveloped viruses, such as human immunodeficiency virus (HIV- 1) and hepatitis B virus (HBV), in the manufacture of intravenous immunoglobulin.

The trade name Gamunex is already registered in all EU countries and Japan.