The commercial launch of HYLENEX recombinant (hyaluronidase human injection) in the United States for use in pediatric rehydration. HYLENEX, an enzyme, allows fluids to be administered under the skin (subcutaneously) rather than through a vein. This allows for rapid treatment initiation and delivery of intravenous (IV)-like fluid rates, which can help lead to successful rehydration of children in a less invasive manner. Marketing authorization from the European Commission for CELVAPAN H1N1 pandemic vaccine using Baxter ™s Vero cell technology. CELVAPAN H1N1 is the first cell culture-based and non-adjuvanted pandemic influenza vaccine to receive marketing authorization in the European Union. Completion of the seasonal influenza Phase III confirmatory study in healthy adults in the United States. The company expects final study results to be available by the end of this year, to support filing for regulatory approval in the United States in the first half of 2010. Initiation of a Phase III study evaluating the use of ARTISS [Fibrin Sealant (Human)] in facial surgery in the United States. Currently, ARTISS is the first and only slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients. ARTISS was developed using Baxter ™s proven fibrin sealant technology platform and is the newest agent in the company ™s expanding biosurgery portfolio. Filing an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) to begin a clinical study to collect safety and effectiveness data required for a 510(k) application for a new home hemodialysis system. Completion of the acquisition of certain assets related to Edwards Lifesciences Corporation ™s hemofiltration product line, also known as Continuous Renal Replacement Therapy (CRRT). CRRT provides a method of continuous yet adjustable fluid removal that can gradually remove excess fluid and waste products that build up with the acute impairment of kidney function, and is usually administered in an intensive care setting in the hospital.
Fourth Quarter and Full-Year 2009 Outlook
Baxter also announced today its guidance for fourth quarter 2009 and updated its guidance for the full year.
For the fourth quarter of 2009, Baxter expects sales growth, excluding the impact of foreign currency, of 6 to 8 percent. Based on the company ™s outlook for foreign exchange rates, the company expects reported sales including the impact of foreign currency to increase 8 to 10 percent over the prior-year period. Baxter also expects to achieve earnings per diluted share of $1.02 to $1.04, before any special items, in the fourth quarter.
For the full year, Baxter expects sales growth, excluding the impact of foreign currency, to increase 7 to 8 percent. Based on the company ™s outlook for foreign exchange rates, Baxter expects reported sales growth to increase approximately 0 to 1 percent. In addition, the company expects earnings per diluted share of $3.79 to $3.81, before any special items, and continues to expect cash flow from operations to total more than $2.6 billion.
A webcast of Baxter's third quarter conference call for investors can be accessed live from a link on the company's website at www.baxter beginning at 7:30 a.m. CDT on October 15, 2009. Please visit Baxter's website for more information regarding this and future investor events and webcasts.
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