Baxter – Business

About

– 1980’s: Contaminated hemophilia blood products infected HIV and Hepatitis C worldwide.
– 2001: Malfunctioning dialysis machines resulted in several deaths in Spain.
– 2008: Intentional contaminated heparin processed in China from pig’s intestines by Scientific Protein Laboratories (Arsenal Capital Partners) resulted in several deaths and serious injuries. Due to procedural errors Changzhou facilities was never subject to an inspection by FDA official, as required by FDA rules. Factory’s products also never certified as safe for use in pharmaceutical products by Chinese FDA officials as Changzhou Scientific Protein Laboratories was itself registered as a chemical company and not a drugs manufacturer.
– 2009: Contaminated vaccine material with Avian flu virus sent to a series of European laboratories. Joseph Moshe, dual national (Israeli-American) Mossad biowar expert, attacked and seized by Federal Agents and LAPD in California, after speaking to Dr. True Ott on his national radio show and warning of a plot by Baxter International to spread a Plague from Baxter’s Ukrainian lab.
– Net income: $2.2 billion in 2008 ; $1.8 billion in 2007.
– Worldwide sales: $12.3 billion in 2008 ; $11.3 billion in 2007 ; $9.8 billion in 2005 ; $9.5 billion in 2004 ; $8.9 billion in 2003.

History

2009
– Exclusive 3 year distribution agreement in the U.S. and international markets with SIGMA International for infusion pumps.
– Baxter is part of the pandemic vaccine supply group set up by WHO.
– Baxter receives the A/H1N1 strain for testing and evaluation from the U.S. Centers for Disease Control and Prevention (WHO Collaborating Center) in early May.
European Medicines Agency approval for a mock up pandemic vaccine called CELVAPAN. Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the European Medicines Agency in 2004.
– Orders from 5 countries, including Britain, Ireland and New Zealand, for a total of 80 million doses of H1N1 vaccine.
– Baxter acquires certain assets related to Edwards Lifesciences Corporation‘s hemofiltration product line, Continuous Renal Replacement Therapy.
– Completed production of first commercial batches of CELVAPAN A/H1N1 pandemic vaccine made using Baxter’s proprietary Vero cell culture technology. Bulk CELVAPAN vaccine is produced at its large-scale commercial facility in Bohumil, Czech Republic, and is sent to Vienna, Austria for the final formulation, fill and finish before distribution.
European Commission grants marketing authorization for CELVAPAN H1N1 pandemic vaccine.
– Commercial launch of HYLENEX recombinant (hyaluronidase human injection) for use in pediatric rehydration.

2008
– Agreement with Nycomed to market and distribute TachoSil patch in the United States.
– Voluntary recall of 9 lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials due to an increase in the number of reports of adverse patient reactions.
– Voluntary recall of all remaining lots and doses of heparin so-dium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.
FDA approval of ARTISS, the first and only slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients.
– Licensing agreement with Innocoll Pharmaceuticals Ltd, a division of Innocoll Inc., to market and distribute gentamicin surgical implant in the United States.

2007
– Clearance from the FDA on upgraded Ipump Pain Management System 510(k) notification.
– Memorandum of Understanding with the Government of Indonesia to provide a framework for future discussions and negotiations related to any formal collaboration or supply agreements for pandemic vaccine.
FDA approval of CEPROTIN, a plasma-derived Protein C concentrate for use as replacement therapy in patients with life-threatening blood-clotting complications related to severe congenital Protein C deficiency.
– Support of the World Federation of Hemophilia‘s Global Alliance for Progress program.
– Available HYLENEX recombinant (hyaluronidase human injection) for the ophthalmology market for use in enhancing the absorption and dispersion of other injected drugs.
FDA approval to transfer ARALAST (human alpha1 proteinase inhibitor) processing from a third party to Baxter.
– Support of the World Health Organization‘s pandemic planning programs through participation in a planned international stockpile program.
– Individual licensing agreements with Intercytex and Spinal Restoration Inc. to evaluate the use of Baxter’s fibrin sealant TISSEEL in novel regenerative medicine therapies.
– Collaboration with DEKA Research & Development Corp. for the development of a next-generation home hemodialysis machine.
– Joint venture with Guangzhou Baiyunshan Pharmaceutical Co. Ltd. to produce and sell parenteral nutrition products in China as Guangzhou Baxter Qiaoguang Healthcare Co. Ltd., based in Guangzhou, China.
– European UK subsidiary enters into advanced supply agreement with the Department of Health that contains an option to purchase pandemic influenza vaccine in the event the World Health Organization declares a pandemic. Already delivered several million doses of H5N1 pre-pandemic vaccine to various governments worldwide.
– Collaboration with Halozyme Therapeutics Inc. for development of subcutaneous GAMMAGARD LIQUID administration using Enhanze technology.
– Multi-year contract extension valued at over $200 million with Novation, the University HealthSystem Consortium‘s contracting services company, for medication delivery products.
– Agreement with Kaketsuken, the Chemo-Sero-Therapeutic Research Institute, based in Kumamoto Japan, for the worldwide rights to develop, manufacture and market the recombinant protein ADAMTS13.
– Clearance from FDA for V-Link with VitalShield, new antimicrobial intravascular technology.
FDA approval of GELFOAM Plus Hemostasis Kit (absorbable gelatin sponge, USP and human thrombin), the only available hemostasis kit that contains Pfizer‘s GELFOAM brand plus Baxter’s Thrombin (Human) for use in controlling bleeding during surgical procedures.
DynPort Vaccine Company, a Computer Sciences Corporation company, in conjunction with Baxter International Inc., receive a $201.2 million contract modification from the U.S. Department of Health and Human Services for the development of Baxter’s cell-cultured seasonal and pandemic influenza candidate vaccines.

2006
– Marketing clearance from the FDA for TricOs T Bone Void Filler.
– Marketing authorization from the European Commission for KIOVIG to treat immunodeficiencies.
– Definitive agreement for Cerus Corporation to obtain Baxter’s remaining commercial rights to the INTERCEPTTM Blood System for platelets and plasma effective.
– Investment of $60 million over the next 5 years to expand production capacity in China to support sales growth in the Medication Delivery and Renal businesses. Sales in China were approximately $100 million in 2005, and are expected to more than double by 2010. In addition to 4 manufacturing facilities in China, Baxter operates 7 others in countries across the Asia Pacific region, including India, Japan, Singapore, Australia and the Philippines.
– Launch of generic azithromycin for injection (Pfizer/Zithromax), a commonly used antibiotic. Pfizer will manufacture generic azithromycin for injection and Baxter will sell and market the product in the United States.
FDA approval for Ultra-High Dosage Strength of ADVATE for Hemophilia A; and ADEPT Adhesion Reduction Solution for use in gynecological laparoscopic procedures.
– Tentative approvals from the FDA for Ondansetron Injection USP, including the first tentative approval for a premix version of GlaxoSmithKline‘s Zofran, used for the prevention of nausea and vomiting.
Halozyme Therapeutics Inc. and Baxter Healthcare Corporation announce the availability of Hylenex, a liquid injectable formulation of recombinant human hyaluronidase, in the United States.
– Agreement on a consent decree with the FDA regarding the COLLEAGUE and SYNDEO infusion pumps.
Health Canada approval of ADVATE for the prevention and control of bleeding episodes in people with hemophilia A.
Genetics Alliance recognizes Baxter for screening program to identify patients at risk for hereditary emphysema.
– Definitive agreement to sell Transfusion Therapies business to Texas Pacific Group for $540 million.
– Marketing approval for ADVATE in Japan.
Pandemic preparedness contract with the Austrian Ministry of Health to supply 16 million doses of pandemic influenza vaccine in the event a pandemic is declared.
– Contract from the National Health Service in the U.K. to produce 2 million doses of candidate H5N1 vaccine for preparedness stockpile.

2005
– Agreement with Cerus Corporation to restructure their collaboration related to the INTERCEPT Blood System.
– Clearance from the FDA to market wireless pump connectivity interface that enables hospitals to connect Baxter’s COLLEAGUE CX infusion pump to its Patient Care System.
– Marketing and distribution rights for Cangene Corporation‘s WinRho SDF in the U.S.
Halozyme Therapeutics and Baxter Healthcare Corporation expand relationship to include development and supply agreement for Enhanze SC, recombinant human hyaluronidase enzyme (rHuPH20).
FDA approves the liquid formulation of Cangene Corporation‘s WinRho SDF; GAMMAGARD Liquid 10% Solution, for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity; ceftriaxone injection offered in frozen, premixed ready-to-use containers; and FLEXBUMIN, the first and only albumin solution to be packaged in a flexible container.
– 2 year, $19.6 million contract from Department of Defense Medical Identification and Treatment Systems Joint Product Management Office in partnership with Dynport Vaccine Company for the development of a plasma-based therapeutic targeted for use in individuals who may be exposed to nerve gas poisons. Dynport Vaccine Company has been developing biological products to protect against potential biowarfare threat agents since 1997.
– Marketing approval from Australia’s Therapeutic Goods Administration for ADVATE to treat haemophilia A.
– In partnership with Acambis Inc., supplies stockpiles of vero cell-derived smallpox vaccine to the U.S. government and 12 countries worldwide.
– Agreement with Gambro Renal Products to distribute and promote hemodialysis instruments worldwide.
Halozyme Therapeutics and Baxter Healthcare Corporation expand relationship to market, sell, and distribute Hylenex in the European Union.
– Collaborative research agreements with Nektar Therapeutics and Lipoxen Technologies aimed at developing longer acting therapeutic forms of blood clotting proteins.
– Agreement with Kuros Biosurgery AG granted Baxter exclusive worldwide rights to develop and commercialize a portfolio of hard and soft tissue-repair products.
FDA clearance allowing blood centers to pursue use of AMICUS-collected platelets stored up to 7 days.
Halozyme Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation announce FDA approval of Hylenex recombinant (hyaluronidase human injection) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs.
– Launch of Sevoflurane, the world’s most widely-used inhaled anesthetic, in China.

2004
– Licensing agreement with Teva Pharmaceutical Industries Ltd. grants exclusive European rights to the development, manufacture and marketing of LEUPROMAXX leuprolide acetate, under development for the treatment of prostate cancer and other hormone-dependent diseases.
– Agreement with InterMune Inc. to co-promote ARALAST to pulmonologists in the U.S.
FDA approval for a generic formulation of the commonly used, intravenous anti-fungal, Fluconazole Injection.
– Subsidiaries of Baxter International Inc. and Cerus Corporation announce closed transaction with BioOne Corporation for the commercialization in parts of Asia of the pathogen inactivation technology, known as INTERCEPT Blood System for platelets.
– European Union expanded approval of ADVATE for use in children with haemophilia A less than 6 years old.

2003
Alpha Therapeutic Corporation receives FDA authorization for Aralast alpha-1 proteinase inhibitor.
– Definitive agreement with ML Laboratories to acquire icodextrin manufacturing facility in Liverpool, England for approximately $10 million.
– Clearance from the FDA for the EXELTRA Family of Single-Use Dialyzers.
– Launch of ALYX Component Collection System, a fast, portable, automated blood collection system that offers blood centers a new approach to increase the supply of red blood cells.
– Research collaboration with GlycoFi Inc. on development new platform for the production of human therapeutic proteins.
– Launch of Aralast, a new alpha-1 antitrypsin therapeutic, also known as Alpha 1 proteinase inhibitor for the treatment of hereditary emphysema.
– Agreement of subsidiaries of Baxter International Inc. and Cerus Corporation with the FDA on steps for regulatory approval for their pathogen inactivation system for platelets.
– Approval from the FDA to market 6% and 10% PREMASOL sulfite-free (Amino Acid) Injections, which provide a mixture of essential and non-essential amino acids for the nutritional support of infants (including those of low-birth weight) and young children requiring total parenteral nutrition.
– Clearance from the FDA to market ARENA, a new hemodialysis device.
FDA approves ADVATE for the prevention and control of bleeding episodes in people with hemophilia A.
– Non-exclusive multi-year agreements with several leading U.S. specialty pharmacy companies, including Accredo Health Inc., Caremark Inc., Curative Health Services and Hemophilia Resources of America to dispense ADVATE for the prevention and control of bleeding episodes in people with hemophilia A.
– Agreement with Miltenyi Biotec for exclusive rights for 5 years to distribute, market and sell Baxter’s cellular therapy products worldwide, with the exception of China, Japan, Korea and Taiwan.
– $10 million contract by the U.S. National Institute of Allergy and Infectious Diseases to develop and produce an inactivated coronavirus vaccine against Severe Acute Respiratory Syndrome (SARS) for use by the National Institutes of Health in phase I/II clinical trials.
Avecia, a leader in biotechnology-derived medicines and vaccines, is awarded a $71.3 million contract to make 3 million doses of a new type of recombinant anthrax vaccine for the U.S. National Institute of Allergy and Infectious Diseases.
– Launch of the Syndeo PCA Syringe Pump, patient-controlled analgesia device.
– Acquisition of certain assets from Alpha Therapeutic Corporation, including Aralast alpha-1 antitrypsin therapeutic.
– Multi-year contract by Department of Veterans Affairs for exclusive sale of intravenous solutions and sets to the more than 170 Veterans Affairs Medical Centers in the U.S.

2002
– Contract by the U.S. National Institute of Allergy and Infectious Diseases to produce 2,000 doses of a new anthrax vaccine for clinical trials.
– Clearance from the FDA to market the Accura Hemofiltration System for continuous renal replacement therapy, and approval of EXTRANEAL PD solution, a non-glucose-based solution that provides increased fluid removal for some dialysis patients.

2001
– Baxter acquires Cook Pharmaceutical Solutions, a manufacturer of prefilled injectable drugs in vials and syringes.
– Production of approximately 155 million doses of smallpox vaccine for the U.S. government, in conjunction with Acambis Inc.

2000
– Baxter spins off of its cardiovascular business as a separate, publicly traded entity under the name of Edwards Lifesciences.
– Baxter joins Johnson & Johnson, GE Healthcare, Abbott Laboratories and Medtronic Inc. to create the Global Healthcare Exchange, an 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 acquires North American Vaccine Inc., that develops, manufactures, and sells vaccines for children and adults to prevent infectious diseases.

The 1990s
– 1991: Introduced the INTERLINK IV Access System, the first “needleless” system for IV therapy, protecting healthcare workers from needle-stick accidents.
– 1992: Introduced RECOMBINATE Antihemophilic Factor (recombinant), the first genetically manufactured factor VIII concentrate.
– 1994: Introduced the HOMECHOICE automated peritoneal dialysis machine, a compact, user-friendly device that cleanses the patient’s blood overnight. Opens a new plant in Singapore to manufacture peritoneal dialysis solutions for the Asian market.
– 1995: Approval in Europe for ISOLEX CD34+ stem-cell separator. Opens a plant in China to manufacture PD solutions for the Chinese market.
– 1996: Plans to open 2 more plants in China to manufacture IV solutions for the Chinese market. Baxter spun off its medical products distribution business as Allegiance Corporation, renewing focus on core technologies of renal technology, biotechnology, and medication delivery. Clearance from the FDA for new COLLEAGUE volumetric infusion pump, designed to provide accurate, cost-effective IV infusion for a broad range of therapies.
– 1997: Baxter acquires Immuno International AG, an international leader in infectious disease research and the development of blood products, related biologics and vaccines.
– 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. Approval from the FDA to market TISSEEL Fibrin Sealant in the U.S., indicated to promote hemostasis and wound-sealing in surgery, and to manufacture RECOMBINATE Antihemophilic Factor (recombinant) at its new biotechnology facility in Thousand Oaks, California.

1931-1991
– 1931: The company is founded as the first manufacturer of commercially prepared intravenous solutions.
– 1939: The Transfuso-Vac container, the first sterile, vacuum-type blood collection and storage unit, is introduced.
– 1941: Many of Baxter’s products were the only ones to meet the specifications of the U.S. Armed Forces during World War II, and temporary plants opened to meet increased demand. Baxter introduces the Plasma-Vac container, providing the first means of separating plasma from whole blood and storing it for future use.
– 1945: Sales exceed $1.5 million.
– 1952: Baxter acquires Hyland Laboratories, the first U.S. company to make human plasma commercially available.
– 1954: The company opens an office in Belgium.
– 1956: Baxter introduces the first commercially built artificial kidney, making life-saving dialysis possible for people with end-stage renal disease.
– 1959: Baxter acquires Fenwal Laboratories.
– 1962: Introduced first disposable blood oxygenator, making open-heart surgery possible.
– 1968: Introduced first commercially produced factor VIII concentrate to treat hemophilia.
– 1970: The VIAFLEX flexible, plastic IV container is introduced.
– 1971: Sales reach $242 million.
– 1978: Sales exceed $1 billion.
– 1979: The first automated blood-cell separator is introduced.
– 1982: The first heat-treated factor VIII concentrate for hemophilia, reducing risk of viral transmission, is introduced.
– 1985: Baxter acquires American Hospital Supply Corporation, becoming a broad-based healthcare products distributor in addition to a developer of medical technologies.
– 1988: HEMOFIL M, the first factor VIII purified by chemical and monoclonal technologies is introduced.

Board of Directors

Walter E. Boomer (1938-)
– Director of Baxter since 1997 and lead director since May 2008.
– Board of Directors of Rogers Corporation and Cytyc Corporation.
– President and Chief Executive Officer of Rogers Corporation (1997-2004).
– Executive Vice President of McDermott International Inc.
– President of the Babcock & Wilcox Power Generation Group (1994-1996).
– 4 star General and Assistant Commandant of the U.S. Marine Corps (34 years of service). Led all Marines in Operations Desert Shield and Desert Storm during the Gulf War.
– B.A. degree from Duke University (1960).

Blake E. Devitt (1947-)
– Director of Baxter since 2005.
– 33-year career at Ernst & Young.

John D. Forsyth (1948-)
– Director of Baxter since 2003.
– Chairman of Wellmark Blue Cross Blue Shield.
– President and Chief Executive Officer at the University of Michigan Health System (1985).
– Bachelor’s degree in business administration and master’s degree in economics from Michigan State University.

Gail D. Fosler (1947-)
– Director of Baxter since 2001.
– President of The Conference Board.
– Director of Caterpillar Inc. and Unisys.

James R. Gavin III, M.D., Ph.D. (1946-)
– Director of Baxter since 2003.
– Director of Amylin Pharmaceuticals Inc.
– Chief Executive Officer and Chief Medical Officer of Healing Our Village Inc.
– Clinical Professor of Medicine and Senior Advisor of Health Affairs at Emory University.
– President of the Morehouse School of Medicine (2002-2005).
– Senior Science Officer at Howard Hughes Medical Institute (1991-2002).

Peter S. Hellman (1950-)
– Director of Baxter since 2005.
– Director of Qwest Communications International Inc. and Owens-Illinois Inc.
– President and Chief Financial and Administrative Officer at Nordson Corporation.
– President and Chief Operating Officer at TRW Inc.

Wayne T. Hockmeyer, Ph.D. (1945-)
– Director of Baxter since September 2007.
– Director of Middlebrook Pharmaceuticals Inc., GenVec Inc. and Idenix Pharmaceuticals
– Founder of MedImmune Inc.
– Vice president of laboratory research and product development at Praxis Biologics Inc.
– Chief of the Department of Immunology at Walter Reed Army Institute of Research.

Joseph B. Martin, M.D., Ph.D. (1939-)
– Director of Baxter since 2002.
– Professor of Neurobiology at Harvard Medical School.
– Dean of the Harvard Faculty of Medicine (1997-2007).
– Chancellor of the University of California (1993-1997).
– Dean of the UCSF School of Medicine (1989-1993).
– Chief of the neurology department of Massachusetts General Hospital.
– Professor of Neurology at Harvard Medical School (1978-1989).

Carole J. Shapazian (1944-)
– Director of Baxter since 2003.
– Executive Vice President of Maytag Corporation.
– Executive Vice President and Assistant Chief Operating Officer of Polaroid Corporation.

Thomas T. Stallkamp (1947-)
– Director of Baxter since 2000.
– Industrial Partner in Ripplewood Holdings L.L.C.
– Chairman of MSX International Inc.
– Vice Chairman and President of DaimlerChrysler Corporation.
– Director of BorgWarner Inc. and Honsel International Technologies S.A.
– Director and non-executive co-chairman of Asahi Tec Corporation.

Albert P.L. Stroucken (1948-)
– Director of Baxter since 2004.
– Chairman, President and Chief Executive Officer of Owens-Illinois Inc.
– President and Chief Executive Officer of H.B. Fuller Company (1998-2006).
– General Manager of the Inorganics Division of Bayer AG (1997-1998).
– Executive Vice President and President of the Industrial Chemicals Division of Bayer Corporation (1992-1997).

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