Baxter Healthcare Corporation and Cangene Corporation announced that, effective immediately, Baxter has assumed exclusive rights to market and distribute Cangene's WinRho SDF [Rho(D) Immune Globulin Intravenous (Human)] in the United States. WinRho SDF is used to treat a critical bleeding disorder called immune thrombocytopenic purpura (ITP). Baxter currently markets WinRho SDF for Cangene in the United Kingdom and intends to launch the therapy in 10 other European countries, a Baxter release said.

"Baxter's knowledge and experience in distributing WinRho SDF in the United Kingdom, along with the company's expertise in marketing bleeding disorder products in the United States, make this partnership a good fit," said Dr John Langstaff, president and chief executive officer of Cangene Corporation.

"WinRho SDF leverages Baxter's expertise in haematology and complements our product portfolio," said Joy Amundson, president of Baxter's BioScience business. "We look forward to working with Cangene to enable a smooth transition to physicians and ITP patients in need of additional treatment options."

ITP is an autoimmune bleeding disorder caused by an abnormally low level of platelets. In ITP, the immune system produces antibodies against platelets causing their premature destruction. Platelets are components of the blood that are necessary for blood to clot properly. Individuals who suffer from ITP may have symptoms such as bruising on skin and gums, nosebleeds, or mucosal bleeding. The most serious risk in patients who develop ITP is intracranial haemorrhage (bleeding into the brain).

"It is estimated that approximately 30,000 people develop ITP in the United States every year, and about half of those affected are children," said Joan Young, president of the Platelet Disorder Support Association (PDSA). "Given the severity of this condition, it is critical for patients to have access to therapies like WinRho SDF."

WinRho SDF, which is used to elevate the platelet level in patients with ITP, is derived from human plasma and administered intravenously for the treatment of ITP. In 1995, the Food and Drug Administration approved WinRho SDF for the treatment of chronic ITP in Rh-positive adults (those with A, B, AB and O-positive blood) and acute and chronic ITP in Rh-positive children who have not had a splenectomy (surgical removal of the spleen).

WinRho SDF [Rh o (D) Immune Globulin Intravenous (Human)] is recommended for the treatment of nonsplenectomized, Rh o (D)-positive children with chronic or acute ITP, adults with chronic ITP, and children and adults with ITP secondary to HIV infection in clinical situations requiring an increase in platelet count to prevent excessive haemorrhage.

Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive WinRho SDF or any other Immune Globulin (Human). Individuals who are deficient in immunoglobulin A (IgA) may have the potential for developing IgA antibodies and have anaphylactic reactions.

Products made from human plasma may carry a risk of transmitting infectious agents. To treat ITP, WinRho SDF must be administered intravenously. WinRho SDF should not be administered to Rh o (D)-negative or splenectomized individuals as its efficacy in these patients has not been demonstrated.

Following administration of WinRho SDF, Rh o (D)-positive ITP patients should be monitored for signs and/or symptoms of intravascular haemolysis (IVH), clinically compromising anaemia, or renal insufficiency.