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FDA Approves Baxter's FLEXBUMIN, the First and Only Albumin Solution to be Packaged in a Flexible Container

 

Packaging advancements provide ease of use benefits to healthcare professionals; launch planned by early 2006

DEERFIELD, Ill., October 17, 2005 – Baxter Healthcare Corporation announced today that the U. S. Food and Drug Administration (FDA) has approved FLEXBUMIN™ [Albumin (Human)] 25% Solution, the first preparation of human albumin to be packaged in a flexible container. The company plans to launch FLEXBUMIN by early 2006.

Baxter's current BUMINATE ® [Albumin (Human)] 25% Solution, packaged in glass bottles, has been used in hospitals throughout the country for more than 50 years in patients undergoing cardiopulmonary bypass surgery and in patients suffering from shock, blood loss and severe burns.

FLEXBUMIN has the same indications and provides the same stability as albumin in glass bottles, but provides improved convenience for healthcare professionals as its flexible packaging provides less risk of breakage and is more compatible with hospital inventory storage systems. The flexible containers are lighter and require less space, which may ultimately save hospitals money on disposal.

“Through the development of FLEXBUMIN, we have leveraged our enhanced packaging technology to create a more convenient container for albumin that meets the changing needs of our customers,” said Larry Guiheen, president of Baxter's BioScience business in North America. “We will continue to look at different ways to leverage our core competencies for further product innovation.”

Historically, albumin has been packaged in glass bottles as a result of technical requirements related to manufacturing, including inertness, sturdiness and a high water vapor and oxygen barrier that no single plastic material has been able to fulfill.

“Our pharmacy and nursing staff will appreciate the additional handling safety benefits and convenience associated with the flexible containers over our current use of glass albumin vials, including the decreased risk of breakage, improved product storage and a significant reduction in our volume of hazardous waste material,” said Larry Ligeski, manager of pharmacy purchasing and distribution, University of Michigan Hospitals and Health Centers. “In addition, FLEXBUMIN will make it easier for our hospital to comply with industry standards.”

FLEXBUMIN uses Baxter's GALAXY ® flexible container system, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at room temperature. GALAXY, which employs barrier technology and a continuous aseptic filling process, has been used in the United States for more than 16 years to package pharmaceutical products.

FLEXBUMIN has the same indications and provides the same stability as BUMINATE, and can be stored for up to two years at room temperature. The solution will be available in both 50 mL and 100 mL flexible containers. All components of FLEXBUMIN are latex-free.


About FLEXBUMIN

FLEXBUMIN is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. FLEXBUMIN is indicated in hypovolemia, hypoalbuminemia due to inadequate reproduction, excessive catabolism, hemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery.

FLEXBUMIN is contraindicated in patients with a history of allergic reactions to albumin, in severely anemic patients, and in patients with cardiac failure.

FLEXBUMIN is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, such as viruses, that can cause disease.

The potential risks and benefits of albumin should be weighed against those of alternative therapies for all patients for whom albumin administration is being considered.

Please visit www.baxter.com for full prescribing information.

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 intention to launch FLEXBUMIN by early 2006 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; the impact of competitive products and pricing; inventory reductions or fluctuations in buying patterns by wholesalers or distributors; the availability of acceptable raw materials and component supply; reimbursement policies of government agencies and private payers; internal and external factors that could impact commercialization; and other risks detailed in the company's filings with the Securities and Exchange Commission. The company disclaims any current intention 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.

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