Bayer HealthCare LLC, Biological Products Division (Bayer BP), said that the recently published data on its novel Immune Globulin Intravenous (Human), met both primary and secondary endpoints for safety and in the treatment of ITP (Idiopathic [immune] Thrombocytopenic Purpura).

Gamunex 10 per cent prylate/Chromatography Purified was approved for the treatment of ITP and other indications in the United States and Canada in August 2003 as well as in Germany earlier this year.

The primary endpoint was to achieve similar platelet count elevation after treatment with Gamunex compared with standard treatment, IGIV-S/D. 90 per cent of patients who were treated with Gamunex achieved target platelet counts within seven days of dosing compared to 83 per cent in the IGIV-S/D group. The secondary endpoint was to maintain platelet counts for at least seven days, which 74 per cent of the Gamunex group achieved compared with 60 per cent of the IGIV-S/D control group.

ITP is an autoimmune disorder of unknown cause that affects both children and adults. ITP occurs when the immune system malfunctions and produces antibodies against the body's own platelets. These antibodies destroy the platelets, resulting in a decreased level of blood platelets needed for normal blood clotting.

Characterised by a low platelet count, notwithstanding normal bone marrow production and the absence of other specific causes (such as leukemia or aplastic anemia), ITP can lead to life-threatening bleeding episodes.

The disorder becomes fatal if a patient's platelet count becomes so low that brain hemorrhaging occurs. Hemorrhaging is the key concern for ITP patients. When platelet counts are too low, internal bleeding can be difficult to stop. Rarely, life-threatening bleeding occurs with intracranial hemorrhage or other serious hemorrhaging.

Each vial of Gamunex contains antibodies purified from the donated blood plasma of thousands of people and can be a lifesaving therapy for individuals with compromised or malfunctioning immune systems. The broad spectrum of antibodies in Gamunex acts as an immune system replacement and provides a shield of protection against infection if the immune system fails.