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Research and Development Fact Sheet

One of Baxter’s competitive strengths is its diverse technological expertise. The company’s unique combination of capabilities in medical devices, pharmaceuticals and biotechnology, including specialty biologics, sets it apart from other companies in the healthcare industry. Increasingly, technologies and scientific disciplines are converging to develop therapies that can be more safely administered and more convenient to patients and clinicians.

 

Newer therapeutic areas, such as regenerative medicine, which combine pharmaceuticals, biotechnology and devices, are advancing through clinical study and have the potential to significantly alter how diseases are treated.

 

The combination of these disciplines and technologies also offers great promise for helping address issues like hospital-acquired infections, medication errors, shortages of health care providers (and related movement toward home-based care), as well as improving access to care and patient quality of life.

Core Technical Competencies

Baxter has six “core technical competencies” that differentiate the company and provide competitive advantages in the marketplace. Each represents a specialized area of technical expertise and leadership that give the company unique capabilities to develop new products. Effectively leveraging these core technical competencies to develop new, unique products that meet critical medical needs is essential to Baxter’s growth. The following are brief descriptions of each of these core technical competencies at Baxter.

 

Medical Plastics

 

Baxter introduced the first flexible plastic blood-collection container in 1959, revolutionizing blood collection and paving the way for modern blood-component therapy. The technology led to the introduction in 1970 of the VIAFLEX container – the first flexible plastic intravenous (IV) solution container – which soon became the industry standard. Soon to follow were the MINI-BAG container systems for IV drugs, and the flexible plastic containers used in peritoneal dialysis, the first portable dialysis therapy.

 

Today, medical plastics are integral to many Baxter product lines. FLEXBUMIN (water-soluble protein), the first and only albumin packaged in a latex-free flexible plastic container, is the result of combining Baxter’s expertise in medical plastics with its expertise in biologics to create a truly unique product in the marketplace.

 

Drug Delivery

 

Baxter introduced the first premixed drugs in IV solution containers in the 1980s. Prior to that time, hospital pharmacists had to add drugs to IV solutions themselves. Baxter was the first company to form alliances with pharmaceutical companies to package their drugs in IV containers and provide them to hospitals in premixed form. Today, Baxter’s drug delivery expertise extends beyond premixed drugs and drug-reconstitution systems to include formulating and packaging injectable drugs in vials and syringes, and advanced drug formulation technologies. For example, HYLENEX, the first and only recombinant human hyaluronidase, enables the absorption and dispersion of fluids and drugs through subcutaneous infusion, offering an alternative to IV administration, for patients with difficult venous access.

 

Biologics

 

Baxter has been at the forefront of research and manufacturing of specialty biologics for more than 50 years. Baxter’s groundbreaking work in the processing and separation of blood and its components is at the foundation of many contemporary biologically derived therapies, including the treatment of hemophilia. Baxter also is involved in leading-edge research and development in biotherapeutics, vaccines and regenerative medicine. Baxter offers unique capabilities in the production of genetically engineered therapies and vaccines in a variety of bacteria, yeast and mammalian cell culture systems; and protein-based processes to perform biological separation and purification.

 

Solutions

 

Baxter’s expertise in the formulation, production and purification of solutions extends back more than 75 years, to its start as manufacturer of the world’s first commercial IV solutions. Since then, Baxter has applied its expertise in solutions to develop a variety of therapies, including parenteral nutrition and peritoneal dialysis. Therapeutic solutions such as these may seem basic, but in fact present a variety of challenges including stability, chemical degradation, compatibility of ingredients and precipitation. Baxter uses a variety of techniques to overcome these challenges and ensure quality, consistency and ease of use.

 

Sterilization

 

Baxter’s diverse product portfolio and extensive manufacturing operations have driven another area of leadership and unique capability – sterilization. Throughout the years, Baxter has pioneered and utilized a range of sterilization platforms to meet the unique requirements and characteristics of its biopharmaceutical, intravenous and injectable pharmaceutical and medical device products. These technologies include the use of steam or heat, ethylene oxide, gamma and electron-beam radiation to sterilize finished product, and the use of proprietary in-line technologies for aseptic manufacturing. Baxter’s technology is the only commercially available aseptic filling process for premixed drugs in flexible IV bags. In 2005, Baxter combined this proprietary flexible plastic container technology with its expertise in biologics to introduce the world’s first albumin (a plasma-based protein) in a plastic container. Baxter’s sterilization expertise extends beyond manufacturing process and technology to include systems for validation and assurance and development of novel chemical and biological indicators and barrier technologies.

 

Hardware and software development

 

Baxter also offers unique capabilities in the design, development and integration of hardware and electronic systems and the software that controls them. Many of the therapies that the company has pioneered over the years – including the administration of intravenous and dialysis solutions – require the use of a device for the controlled delivery of fluids. Baxter also incorporates human factors (the manner in which a clinician or patient interacts with or uses a device) into the design of products to ensure ease of use, and safe and effective delivery of therapy.

Advancing its Pipeline

In 2007, Baxter increased its spending on research and development (R&D) 24 percent, to $760 million – the highest level in the company’s history. The company plans to continue to grow R&D spending faster than sales, with an increasing percentage of R&D investment in exploratory R&D and early-stage initiatives.

 

In 2007, Baxter continued to make solid progress with respect to its R&D pipeline. The company obtained approval for or launched more than a dozen new products and therapies during the year. Additional activities included:

  • Completed screening patients for enrollment in a Phase II clinical trial using Baxter’s proprietary ISOLEX technology to select CD34+ adult stem cells from patients with chronic myocardial ischemia, a severe form of coronary artery disease, for re-infusion into their hearts in an attempt to restore blood flow
  • Initiation of a Phase III clinical trial of the company’s H5N1 pandemic influenza vaccine
  • Development of higher dosage strengths and longer-acting forms of recombinant clotting factor for hemophilia therapy
  • Collaborative research initiative to combine Baxter’s TISSEEL fibrin sealant with complementary technology to potentially regenerate skin and bone
  • Development of a subcutaneous route of administration for GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] (IGIV) , which may provide a more patient-friendly alternative to IV infusion for patients with primary immune deficiency
  • Collaborative initiative to develop a home hemodialysis (HHD) platform that provides another option for patients seeking home dialysis for end-stage renal disease
  • Involvement in clinical trials studying the use of GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] (IGIV) as a possible treatment for Alzheimer’s disease
 
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