Bayer Biological Products receives approval in Canada for Gamunex

Bayer HealthCare LLC, Biological Products Division (Bayer BP) through its Canadian affiliate Bayer Inc., has received approval from Health Canada for Gamunex, Immune Globulin Intravenous (Human), 10%, its new IGIV product.

Gamunex is approved for use in Canada for the treatment of idiopathic thrombocytopenic purpura, primary immune deficiencies, allogeneic bone marrow transplantation, and pediatric HIV infection. It is said to offer a wide range of patient benefits, including rapid infusion, excellent tolerability, and room temperature storage.

Gamunex is the first new IGIV product to be approved in Canada for several years. Bayer BP used a 'clean sheet' approach to develop an optimal production process, featuring an innovative caprylate/chromatography purification process that improves product quality and reliability. The large, multinational clinical development programme demonstrated clinical efficacy, safety, and tolerability of Gamunex.

'The first worldwide approval of Gamunex marks a major milestone in bringing our next generation IGIV to market,' said Dr Gunnar Riemann, president, Bayer BP. 'The approval in Canada, and our anticipated approval in the US, will allow us to implement our phased global launch strategy with an initial focus on North America, the largest IGIV market in the world.'

Gamunex is expected to be available to patients in Canada in early 2004.