Liquid Offers Important Treatment Option for Bleeding Disorder

 

DEERFIELD, Ill., TORONTO and WINNIPEG, Canada, April 11, 2005 – Baxter Healthcare Corporation and Cangene Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved the liquid formulation of Cangene's WinRho® SDF [Rho(D) Immune Globulin Intravenous (Human)]. WinRho SDF is used to treat a critical bleeding disorder called immune thrombocytopenic purpura (ITP).

 

WinRho 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 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 chief executive officer. “We're pleased to provide an alternative formulation of WinRho 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 SDF Liquid in the U.S. later in 2005.”

 

Baxter currently markets lyophilized WinRho SDF for Cangene in the United States and the United Kingdom and intends to launch this therapy in 10 other European countries.

 

WinRho 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 SDF is available at www.winrho.com or by phone at 1-800-4WINRHO.

 

About WinRho SDF

 

WinRho 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 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 Rho(D)-negative or splenectomized individuals as its efficacy in these patients has not been demonstrated.

 

Following administration of WinRho 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 Cangene

 

Cangene is one of Canada's largest biotechnology companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene has been listed on the Toronto Stock Exchange since 1991 under the symbol CNJ. 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 offering contract R&D and manufacturing services to the biopharmaceutical industry. For more information about Cangene, please visit www.cangene.com .

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 www.baxter.com .

 

Statements in this press release including but not limited to Baxter's anticipation that healthcare providers will be receptive to the advantages of the liquid formulation of WinRho SDF, Baxter's commitment to launch WinRho SDF Liquid in the U.S. later in 2005 and Baxter's intention to launch WinRho SDF in ten other European countries are forward-looking statements that involve risks and uncertainties. Actual results could differ materially from the above forward-looking statements as a result of certain factors, including the risk and uncertainty related to actions of regulatory bodies and other government authorities, including the FDA and foreign counterparts that could delay, limit or suspend product sales and distribution; product quality and/or patient safety concerns leading to product recalls, withdrawals, launch delays or declining sales; product development risks; technological advances in the medical field; demand for and market acceptance risks for new and existing products and other technologies; reimbursement policies of government agencies and private payers; internal and external factors that could impact commercialization; and other risks detailed in each company's filings with the Securities and Exchange Commission. The companies do not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise, and all forward-looking statements speak only as of the time when made.  Actual results or experience could differ materially from the forward-looking statements.