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Hemofil

Baxter International

Baxter International Inc. is a global healthcare company with 48,000 employees and 2006 sales of US$10.4 billion. Its headquarters is in Deerfield, Illinois.

The company offers a diversified line of specialized medical products, generally categorized as BioScience (US$4.4 billion in blood collection products and pharmaceuticals derived from blood plasma), Medication Delivery (US$3.9 billion in products for intravenous therapy, and Renal (US$2.1 billion in products for peritoneal dialysis and hemodialysis). About 80% of its revenue comes from the U.S., Canada and Europe, with the rest primarily from Asia and Latin America.

The company has enjoyed strong growth through much of its history, and has been an innovator in many medically-related fields.

History

1931 - The company is founded as the first manufacturer of commercially prepared intravenous solutions.

1933 - During its first two years, the company distributed products manufactured by another company in Los Angeles owned by Dr. Donald E. Baxter, a former medical missionary to China. In 1933, the company opened its first manufacturing facility in a renovated automobile showroom in Glenview, Illinois. There, six employees turned out the complete line of five solutions in glass containers.

1939 - In 1939, the company, now named Baxter Laboratories, introduced the Transfuso-Vac container, the first sterile, vacuum-type blood collection and storage unit. Before this breakthrough product, blood could be stored for only a few hours; the new container allowed storage for up to 21 days, making blood banking practical for the first time. The 1940s

1941 - When World War II broke out, many of Baxter's blood-collection devices and 25 solutions were the only ones that met the specifications of the U.S. Armed Forces.

The Plasma-Vac container provides the first means of separating plasma from whole blood and storing it for future use. 1945 - A young patent lawyer named William B. Graham joined the company in 1945 as vice president and manager, and in 1953, succeeded founder Ralph Falk as chief executive officer (CEO). In 1945, sales exceed $1.5 million.

1947 - In 1947, the company moved from its Glenview plant to a larger, central base of operations in Morton Grove, Illinois.

1948 - In 1948, Dr. Carl Walter, a noted Boston surgeon and co-founder of Fenwal Laboratories, invented the non-breakable Blood-Pack plastic container.

The 1950s

1950 - In 1950, the company opened its second U.S. plant, in Cleveland, Mississippi.

1952 - Baxter acquired Hyland Laboratories, the first US company to make human plasma commercially available.

1953 - William B. Graham becomes president and chief executive officer, and Baxter begins 25 consecutive years of more than 20-percent annual earnings growth.

1954 - The company expanded internationally with the opening of an office in Belgium.

By 1956, Baxter medical engineers had improved the original construction and had meticulously built 184 working artificial kidneys. Baxter introduced the first commercially built artificial kidney, making life-saving dialysis possible for people with end-stage renal disease. However, the artificial kidney did not immediately receive widespread acceptance in the medical community. The company persevered and today provides products for hemodialysis, peritoneal dialysis (PD) and continuous ambulatory peritoneal dialysis (CAPD), as well as transplantation. 1959 - Fenwal Laboratories was purchased in 1959. The unit's BLOOD-PACK plastic system for collection and processing of whole blood later led to Baxter's development of the VIAFLEX plastic IV bag, another major innovation in IV therapy. More recently, the technology was applied in the development of a flexible plastic delivery system for dialysis solutions for continuous ambulatory peritoneal dialysis (CAPD), another Baxter first.

In the late ´50s, Baxter formally established an international division to sell Baxter products around the world. Today, more than half of Baxter sales come from non-U.S. markets. Today, the company has more than 250 facilities in 50 countries around the world and its products are used by patients and health-care professionals in more than 100 countries.

The 1960s

1960 - Edwards Laboratories, later to become a division of Baxter, introduces the first implantable heart valve in the United States. Over the next few years, Edwards also introduced the industry's first "balloon" catheters for therapeutic use: the SWAN-GANZ cardiac-monitoring catheter and the FOGARTY catheter for removing clots from peripheral blood vessels.

1961 - Baxter's performance had made it increasingly attractive to investors, and on May 15, 1961 Baxter stock began trading on the New York Stock Exchange. During the ´60s , Travenol (from inTRAVENous sOLutions) was added to the company name and the Travenol "flag" was introduced.

1962 - Baxter introduces the first disposable total-bypass blood-oxygenator.

1966 - The company's Hyland division introduces the first commercially produced Factor VIII concentrate to treat hemophilia.

1969 - Baxter opened its Round Lake, Illinois research facility. The 1970s

1970 - Throughout the ´60s, Baxter had worked to adapt plastic container technology for use in IV therapy. The result was the VIAFLEX plastic IV container, a major advance in IV therapy because it allowed the infusion of a solution without opening the system to contamination. US Food and Drug Administration approval for the Viaflex bag started Baxter on a high note for the next decade.

Baxter introduced the first disposable "bubble" oxygenator for heart-lung bypass with the help of renowned heart surgeons Michael DeBakey and Denton Cooley. In blood therapy, Hyland introduced HEMOFIL antohemophilic factor, a revolutionary product for the treatment of hemophilia.

1971 - Baxter joins Fortune magazine's listing of the 500 largest American corporations. Sales for the year reach $242 million.

1975 - The company moves into its current corporate headquarters in Deerfield, Illinois.

1978 - Baxter introduces continuous ambulatory peritoneal dialysis (CAPD) as a practical alternative to hemodialysis. The company's sales for the year exceed $1 billion.

1979 - The company introduces the first automated blood-cell separator, the CS-3000 system. The 1980s 1980 - Vernon R. Loucks Jr. becomes president and chief executive officer, succeeding William B. Graham.

1984 - The Novacor left-ventricular assist system (LVAS), a technology later acquired by Baxter, becomes the first LVAS to keep alive a patient with a dying heart until a donor heart becomes available for transplant.

1985 - Baxter acquires American Hospital Supply Corporation, becoming a broad-based health-care products distributor in addition to a developer of medical technologies. The 1990s 1991 - The company introduced the INTERLINK IV Access System, the first "needleless" system for IV therapy, protecting health-care workers from needle-stick accidents.

1992 - Hyland introduced RECOMBINATE Antihemophilic Factor (recombinant), the first genetically manufactured Factor VIII product.

1994 - Baxter introduced the HOMECHOICE dialysis machine, a compact, user-friendly device that cleanses the patient's blood overnight.

The Novacor LVAS is approved for sale in Europe as either a "bridge" to transplant or a long-term alternative to transplant.

1995 - Baxter gained approval in Japan for its new AMICUS blood-cell separator; approval in Europe for its ISOLEX cell-separator system; and U.S. approval for its new SPIRALGOLD oxygenator.

Nextran becomes a wholly owned affiliate of Baxter, focusing on research in xenotransplantation, or animal-to-human transplants.

1996 - Baxter spins off Allegiance Corporation, America's leading provider of health-care products and cost-management services. Baxter's HemAssist (DCLHb) hemoglobin therapeutic, or "blood substitute," is the first to receive clearance by the U.S. Food and Drug Administration to enter Phase III clinical testing for patients in elective surgery and those suffering from severe trauma.

1997 - Baxter launches the AMICUS automated blood-component collection and separation system in the United States. The system received approval in Japan in 1995 and in Europe in 1996.

Baxter acquires Immuno International AG, an international leader in infectious disease research and the development of blood products, related biologics and vaccines.

The first comprehensive system for Vacuum-Assisted Venous Return is introduced. The system, which facilitates cardiopulmonary bypass during conventional and minimally invasive cardiac surgery, uses vacuum capabilities already present in the operating room to perform efficient perfusion through smaller cannulae. 1998 - Baxter acquires Ohmeda's Pharmaceutical Products Division from The BOC Group, the North American leader in the production of inhalation agents and drugs used for general and local anesthesia in surgical suites and intensive care units.

Baxter acquires Somatogen, a biopharmaceutical company developing recombinant hemoglobin technology.

Baxter receives approval from the U.S. Food and Drug Administration to market its TISSEEL Fibrin Sealant, the first fibrin sealant to receive approval in the United States, indicated as an adjunct to hemostasis, and replicating the natural blood clotting process to stop bleeding in surgical procedures involving cardiopulmonary bypass and repair of the spleen. Tisseel also is indicated as a sealant for colostomy closure.

Baxter receives clearance from the U.S. Food and Drug Administration for its Novacor® LVAS in the United States as a bridge to a heart transplant.

Baxter receives approval from the U.S. Food and Drug Administration to manufacture RECOMBINATE Antihemophilic Factor (recombinant) at its new biotechnology facility in Thousand Oaks, California. 1999 - Harry M. Jansen Kraemer, Jr., becomes chief executive officer, succeeding Vernon R. Loucks Jr.

Baxter introduces HomeChoice PRO with PD Link, an advanced at-home kidney dialysis system designed to improve the care of people with chronic kidney failure by using advanced computer technology to automatically monitor and communicate critical therapy data from a patient's home to his or her physician. The 2000s 2000 - Harry M. Jansen Kraemer, Jr, becomes chairman of the board of directors, in addition to chief executive officer, succeeding Vernon R. Loucks Jr.

Baxter acquires Althin Medical A.B., a leading manufacturer of hemodialysis products.

Baxter completes the spin-off of its cardiovascular business as a separate, publicly traded entity under the name of Edwards Lifesciences.

Baxter is one of five leading health-care companies to create the Global Healthcare Exchange, an independent, Internet-based company that facilitates the exchange of information related to buying, selling and distributing medical equipment, devices and healthcare products and related services worldwide.

Baxter's North Cove, NC, facility is named a recipient of the prestigious Shingo Prize for Excellence in Manufacturing.

Baxter completes $380 million acquisition of Columbia, Maryland-based North American Vaccine.

2001 - Baxter defective dialysis equipment cause death of 23 people in Croatia and 10 in Spain

Baxter launches its new SEPACELL RZ-2000 leukoreduction filter for use with whole blood for transfusion.

Baxter acquires Sera-Tec Biologicals, L.P. through its Community Bio-Resources. Sera-Tec owns and operates plasma centers and a central testing laboratory.

Baxter's Mountain Home, Arkansas, facility is named a recipient of the prestigious Shingo Prize for Excellence in Manufacturing.

Baxter acquires Cook Pharmaceutical Solutions, a unit of Cook Group Incorporated.

Baxter acquires proprietary recombinant erythropoietin (epo) drug for the treatment of anemia.

Baxter completes acquisition of ASTA Medica Onkologie GmbH & Co KG, a subsidiary of Düsseldorf-based Degussa, AG for approximately $470 million.

Baxter announced that it would participate in the production of approximately 155 million doses of smallpox vaccine for the United States government, in conjunction with Acambis Inc. 2002 - Baxter receives regulatory approval in the Netherlands for INFLUJECT, the company's novel new influenza vaccine.

Baxter's Mountain Home, Arkansas, facility named a STAR site as part of the Occupational Safety and Health Administration's (OSHA) Voluntary Protection Program, which recognizes exemplary safety and health programs.

Baxter completes acquisition of Fusion Medical Technologies for approximately $157 million of Baxter common stock in a stock-for-stock merger. Baxter receives clearance from the U.S. Food and Drug Administration to market the Accura Hemofiltration System, the company's new instrument that delivers continuous renal replacement (CRRT) and plasma therapies in critical care settings. Baxter announces definitive agreement to acquire Alpha-1 Antitrypsin and other assets from Alpha Therapeutic Corporation. Baxter completes its acquisition of the majority of ESI Lederle (ESI), a division of Wyeth, for approximately $305 million in cash. Baxter receives FDA approval of EXTRANEAL (icodextrin), a peritoneal dialysis (PD) solution.

2003 - Baxter announces that the Japanese Ministry of Health, Labor and Welfare approved EXTRANEAL (icodextrin), a peritoneal dialysis (PD) solution, in Japan. Baxter receives 510K clearance from the U.S. Food and Drug Administration to market ARENA, a hemodialysis device that offers a broad range of features to assist health-care professionals administer therapies to end-stage renal disease patients through a more user-friendly design. Baxter announces that the U.S. Food and Drug Administration (FDA) approved ADVATE for people with hemophilia A. ADVATE is a factor VIII made without any added human or animal plasma proteins and albumin in the cell culture process, purification and final formulation, thereby eliminating the risk of infections caused by viruses that may be carried in these proteins. Baxter announces the launch of the Syndeo PCA Syringe Pump, which delivers pre-determined doses of pain medication to patients on a prescribed basis. Baxter announces the completion of its acquisition of certain assets from Alpha Therapeutic Corporation, including Aralast alpha-1 antitrypsin therapeutic.

Baxter’s board of directors elects Robert L. Parkinson, Jr. as the company’s new chairman and chief executive officer, succeeding Harry M. Jansen Kraemer, Jr. Baxter announces the U.S. Food and Drug Administration's approval of Fluconazole, a generic formulation of a commonly used, intravenous anti-fungal, used in the treatment of serious fungal (Candida) infections.

2005 - Baxter receives 510k clearance from the U.S. Food and Drug Administration to market its wireless pump connectivity interface that enables hospitals to connect Baxter's COLLEAGUE CX infusion pump to its Patient Care System.

Baxter and Cangene Corporation receive approval from the U.S. Food and Drug Administration for the liquid formulation of WinRho SDF.

Baxter receives marketing approval from Australia's Therapeutic Goods Administration for ADVATE to treat haemophilia A.

Baxter receives approval from the U.S. Food and Drug Administration for GAMMAGARD Liquid 10% for patients with primary immunodeficiency disorders.

2006 - Baxter sell its Transfusion Therapies division to TPG, including manufacturing facilities and sales.

February 27, 2007

After the 2003 pump recall, Baxter received notice on 2/27/2007 from the FDA that the pump would now be available for medical use (Baxter.com news at )

Quality issues

In 2008 the quality of blood thinning products produced by Baxter was brought into question when they were linked to 19 deaths in the US. Upon inspection one of the raw ingredients used by Baxter were found to be contaminated - between 5 and 20 percent - with a substance that was similar, but not identical, to the ingredient itself. Enough for them to be considered sub-potent and thus unsuitable for use. Baxter did not pick up on the contamination until after the FDA became involved.

Investigation into the contamination has focused on raw heparin produced by Changzhou Scientific Protein Laboratories, a China based branch of Scientific Protein Laboratories, based in Waunakee, Wisconsin. Due to procedural errors Changzhou SPL's facilities was never subject to an inspection by US FDA official, as required by FDA rules. The factory's products were also never certified as safe for use in pharmaceutical products by Chinese FDA officials as Changzhou SPL was itself registered as a chemical company and not a drugs manufacturer.

Global Presence

There is a map of all the offices worldwide available at the U.S.-site of Baxter

Products

The following is a list of areas in which Baxter manufactures products, as found on the Baxter website, retrieved 2005-08-11.

It is important to know that the display of available products in the healthcare sector is different in almost every country because of local regulations. In general, the U.S.-sites give you broader access to their products.

Anesthesia
IV Anesthesia
Pain Pumps
Regional Anesthesia
Anesthetic Pharmaceuticals

Biopharmaceuticals
Hemophilia
Antibody Therapies
Critical Care
Pulmonology
BioSurgery

Blood Collection and Transfusion
Automated Component Collection
Manual Collection & Processing Systems
Ancillary Blood Products

Medication Management
Infusion Pumps
IV Fluids and Medications
IV Tubing and Access Devices
Nutrition
Patient Care System

Oncology
Chemoprotectants
Elastomeric Pumps
Cellular Therapy
Specialty Collections

Renal
Peritoneal Dialysis
Hemodialysis
CRRT
Software

Competitors

References

External links

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