Baxter continues to focus on enhancing growth by optimizing its core business portfolio, advancing the company’s new product pipeline, pursuing and accelerating the pace of business development initiatives, and capitalizing on the opportunity to develop new business models, which include public and private partnerships aimed at improving the quality of and access to care in both developed and emerging markets. Recent achievements reflect these priorities and include the following:
- Baxter launched its new 4000 IU dosage strength of ADVATE, providing the convenience of a single vial dosing opportunity for many adult patients, including those patients on a dosing schedule of every three days for prophylactic treatment with ADVATE.
- Baxter submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of BAX 326, a recombinant factor IX (rFIX) protein being investigated for the treatment and prophylaxis of bleeding episodes for patients over 12 years of age with hemophilia B.
- Baxter completed enrollment in the first study of the company’s home hemodialysis system. The study was designed to examine the performance and safety of the investigational device. The study was conducted in the United States and 24 patients were enrolled in the study during which 700 treatments were delivered to participants. Data will support the company’s submission for CE Mark in 2013.
- The company began dosing patients with malignant solid tumors in a Phase I clinical trial of a monoclonal antibody, representing the company's efforts to extend its oncology portfolio with advanced biological research and development. The candidate is a fully-human, recombinant anti-MIF (anti-macrophage migration inhibitory factor) monoclonal antibody with potential to be a new therapeutic agent in treatment of cancer.
- Baxter entered into a European licensing agreement with Onconova Therapeutics, Inc. for rigosertib, a novel targeted anti-cancer compound currently in a Phase III study for the treatment of a group of rare hematologic malignancies called Myelodysplastic Syndromes and in a Phase II/III study for pancreatic cancer.
- Under the terms of an agreement with Momenta Pharmaceuticals, Baxter recently selected a third biosimilar for development, a monoclonal antibody for oncology designated as M511. This is in addition to the selection of M923 and M834 earlier this year, targeted for the treatment of autoimmune and other inflammatory disorders. Baxter and Momenta have the opportunity to develop up to six biosimilars through their partnership.
- The government of Brazil announced the selection of Baxter as an exclusive partner for recombinant FVIII hemophilia treatments. The company is working closely with Brazilian authorities to finalize the agreement and enhance access to critical treatments and provide recombinant therapies to patients.
Outlook for Fourth Quarter and Full-Year 2012
For the fourth quarter of 2012, the company expects earnings of $1.24 to $1.27 per diluted share, before any special items, and sales growth of 5 to 6 percent excluding the impact of foreign currency (or 3 to 4 percent including the impact of foreign currency).