Innovation in Action
Advancing the Pipeline
Baxter's competitive strengths include its diverse technological expertise and commitment to scientific innovation. 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, resulting in more new therapies for patients and clinicians. The combination of these disciplines and technologies offers great promise in addressing issues like medication errors and hospital-acquired infections.
Baxter has hundreds of scientists working at research and development (R&D) centers around the world. Principal areas of strategic focus for R&D include recombinant and plasma-based therapeutics, vaccines, biosurgery, kidney dialysis, the formulation of small molecule drugs, enhanced packaging and infusion systems for medication delivery, as well as parenteral nutrition.
In 2012, Baxter increased its investments in research and development to $1.2 billion, reflecting an annual increase of 22 percent. At the close of 2012, Baxter had a number of products in Phase III development, plus many others in earlier stages. These include new products and line extensions across Baxter's BioScience and Medical Products businesses, addressing key areas of unmet patient need. To further enhance Baxter's early-stage pipeline, the company continued its Baxter Ventures initiative to invest in promising early-stage therapies and technologies in line with Baxter's strategic direction.
Baxter's growth depends on a consistently innovative pipeline of new offerings that broaden the company's portfolio of medically necessary products and therapies while reinforcing its leadership in core therapeutic areas. Examples in 2012 include:
- Meeting Unmet Needs: A focus of Baxter's R&D pipeline is on products and therapies that have the potential to satisfy unmet clinical needs by improving earlier diagnosis, prevention and treatment and providing new, unrecognized solutions.
- Baxter received FDA approval for an expanded indication for GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] to include treatment for multifocal motor neuropathy.
- Baxter completed Phase I clinical trials of BAX 855, a longer-acting recombinant factor VIII protein for the treatment of hemophilia A based on the full-length ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] molecule.
- Baxter initiated a Phase III clinical trial evaluating the efficacy and safety of adult autologous (an individual's own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia.
- Baxter initiated a Phase I clinical trial of a fully human, recombinant anti-MIF (anti-macrophage migration inhibitory factor) monoclonal antibody to treat patients with malignant solid tumors.
- Baxter received regulatory approval in Europe for VEPACEL, a pre-pandemic influenza vaccine against the H5N1 subtype of influenza A (commonly known as bird or avian flu), in all European Union Member States.
- Baxter received regulatory approval in China for ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method], for the control and prophylaxis of bleeding episodes in individuals with hemophilia A. With this action, ADVATE is now approved in more than 50 countries worldwide.
- Advancing Home Therapy: Baxter is improving technologies to benefit patients by providing home therapy options.
- Baxter advanced clinical trials on its home hemodialysis (HD) system, supporting the administration of High-Dose HD therapy in the home setting, and initiated a nocturnal in-center trial in Canada.
- Baxter received a positive opinion from the European Medicines Agency for HyQvia (solution for infusion for subcutaneous use). In the United States, Baxter continued the regulatory approval processes. HyQvia is a facilitated subcutaneous immunoglobulin therapy for patients with immune deficiencies.
- Improving Delivery of Care: Baxter is advancing several therapies that have the potential to impact the way care is delivered to patients through innovative uses of new and existing technologies.
- Baxter submitted a biologics license application to the FDA for BAX 326, a recombinant factor IX protein being investigated for the treatment and prophylaxis of bleeding episodes for patients over 12 years of age with hemophilia B.
- Baxter received FDA approval of a new 4000 IU dosage strength of ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method], and is the only company to offer a 4000 IU dosage strength that provides the convenience of a single vial dosing opportunity for many adult patients.
- Baxter received FDA approval of an expanded indication for TISSEEL [Fibrin Sealant] to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical.
- Baxter received approval of triple-chamber parenteral nutrition systems OLIMEL (amino acids, dextrose and lipids, with/without electrolytes) in Asia-Pacific, Europe, Latin America and Canada, and NUMETA (nutritional emulsion for infusion) in select European countries.
Research and development and scientific productivity continue to be key strategic priorities for Baxter to drive innovation and advance the business for the long term.