Cangene and Baxter announce U.S. FDA approval of liquid formulation of WinRho(R) SDF
Cangene and Baxter announce U.S. FDA approval of liquid formulation of WinRho(R) SDF
Liquid Offers Important Treatment Option for Bleeding Disorder
April 11, 2005
Corporation and Baxter Healthcare Corporation today announce that the U.S. Food and Drug Administration (FDA) has approved the liquid formulation of
Cangene's WinRho(R) SDF (Rho(D) Immune Globulin Intravenous (Human)). WinRho(R) SDF is used to treat a critical bleeding disorder called immune
thrombocytopenic purpura (ITP).
WinRho(R) SDF Liquid provides an alternative to the lyophilized (freeze-dried) therapeutic, which eliminates the need for reconstitution prior to administration. Last month, Baxter assumed from Cangene exclusive rights to market and distribute WinRho(R) SDF in the U.S., a lyophilized version of which has been available in the U.S. since 1995.
"Ease of administration can be an important feature for a drug," said Dr. John Langstaff, Cangene's president and CEO. "We're pleased to provide an
alternative formulation of WinRho(R) SDF that offers increased convenience for physicians treating this bleeding disorder."
"We anticipate that healthcare providers will be very receptive to the advantages of the liquid formulation," said Joy Amundson, president of Baxter's BioScience business. "We are committed to launching WinRho(R) SDF Liquid in the U.S. later in 2005."
Baxter currently markets lyophilized WinRho(R) SDF for Cangene in the United States and the United Kingdom, and intends to launch this therapy in 10
other European countries.
WinRho(R) SDF is derived from human plasma and administered intravenously for the treatment of ITP, which 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 hemorrhage (bleeding into the brain).
More information about WinRho(R) SDF is available at or by phone at 1-800-4WINRHO.
About WinRho(R) SDF
WinRho(R) SDF (Rho(D) Immune Globulin Intravenous (Human)) is recommended for the treatment of nonsplenectomized (spleen has not been surgically
removed), Rho(D)-positive (those with A, B, AB and O positive blood types) patients who are: 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 hemorrhage.
Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive WinRho(R) 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
Products made from human plasma may carry a risk of transmitting infectious agents. To treat ITP, WinRho(R) SDF must be administered intravenously. WinRho(R) SDF should not be administered to Rho(D)-negative or splenectomized individuals as its efficacy in these patients has not been demonstrated.
Following administration of WinRho(R) SDF, Rho(D)-positive ITP patients should be monitored for signs and/or symptoms of intravascular hemolysis
(IVH), clinically compromising anemia, or renal insufficiency.
About Baxter
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune
disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful
difference in patients' lives. For more information about Baxter, please visit
About Cangene
Cangene is one of Canada's largest biotechnology companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and Winnipeg. It uses patented manufacturing processes to produce plasma-derived and recombinant
therapeutic proteins. In addition to two approved products, Cangene now has three products that have been submitted for regulatory review, and a
significant clinical trial program. Cangene is also expanding its contract research and manufacturing businesses using its drug-manufacturing expertise
and the resources of Chesapeake Biological Laboratories, Inc. (a wholly-owned subsidiary). The Company has manufacturing facilities in Winnipeg, Manitoba
and Baltimore, Maryland. Cangene's website,, includes product and investor information, including past news releases. Chesapeake's website is
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