Baxter continued to advance its product pipeline and expand its business portfolio with the achievement of several milestones during the quarter, including:
- Launch of HyQvia as a replacement therapy for adults with primary and secondary immunodeficiencies in Germany. Additional EU market launches are scheduled for the coming months and U.S. regulatory activities remain on track.
- U.S. launch of RIXUBIS [Coagulation Factor IX (Recombinant)] for routine prophylactic treatment, control of bleeding episodes, and perioperative management in adults with hemophilia B. RIXUBIS is the first new recombinant factor IX (rFIX) approved for hemophilia B in more than 15 years and is the only rFIX indicated for both routine prophylaxis and control of bleeding episodes for adult patients living with this chronic condition.
- Continued global expansion of the company’s parenteral nutrition portfolio with the launch of CLINOMEL in China and OLIMEL in Brazil. Baxter also received U.S. Food and Drug Administration approval for its CLINOLIPID, (20% Lipid Injectable Emulsion), an olive oil-based lipid emulsion used in parenteral nutrition, indicated for adults.
- Approval from the EMA to include PK-guided dosing information in ADVATE’s EU label. This information is based on a Phase IV prophylaxis clinical study and offers some patients the option of a dosing schedule of every three days. In the study, PK-guided and standard prophylactic dosing regimens were comparably effective in reducing annual bleeding rates.
- Execution of an exclusive distribution and license agreement between Baxter and JW Holdings for parenteral nutritional products containing a novel formulation of omega 3 lipids. With this collaboration, Baxter will complement its leading global parenteral nutrition portfolio, and provide global commercial capabilities and clinical development.
- Announcement of an exclusive collaboration with Coherus Biosciences to develop and commercialize a biosimilar to etanercept in Europe, Canada, Brazil and other markets.
Outlook for Fourth Quarter and Full-Year 2013
Baxter also announced today its financial outlook for the fourth quarter and confirmed earnings guidance within its previously stated range for the full-year 2013. The company’s guidance for the quarter and the full-year includes the impact of the Gambro acquisition.