Key Developments: Baxter International Inc (BAX.N)
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Latest Key Developments (Source: Significant Developments)
Baxter International Inc Receives Marketing Authorization For Hyqvia In European Union
Baxter International Inc and Halozyme Therapeutics, Inc announced that the European Commission has granted Baxter marketing authorization in all European Union (EU) Member States for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. Baxter will introduce HyQvia in select countries during 2013 and plans to expand the launch to other EU countries in 2014. The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC. The application was based on results from a phase III, prospective, open-label, non-controlled multi-center clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of the study was to infuse a 3-or 4-week dose of the treatment in a single subcutaneous site. The rate of validated acute serious bacterial infections in the study was 0.025 per patient per year, which is below the required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In the tolerability assessment of HyQvia, the most frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions). Full Article
Baxter International Inc Raises Dividend
Baxter International Inc announced that Board of Directors declared a quarterly dividend of $0.49 per Baxter common share, payable on July 1, 2013 to shareholders of record as of the close of business on June 7, 2013. Full Article
Baxter International Inc Comments On Q2 2013 Revenue Guidance; Issues Q2 2013 EPS Guidance In Line With Analysts' Estimates; Reaffirms FY 2013 Guidance
Baxter International Inc announced that for second quarter of 2013, it expects sales growth, excluding the impact of foreign currency, of approximately 4% and earnings per diluted share (EPS) of $1.12 to $1.14, before any special items. The Company reaffirmed fiscal 2013 guidance and expects sales growth, excluding the impact of foreign exchange, of approximately 10%. In addition, the company expects earnings of $4.60 to $4.70 per diluted share, before any special items, and cash flows from operations of approximately $3.3 billion. The company's full-year guidance includes the impact of the Gambro AB acquisition, which is projected to be dilutive to full-year 2013 earnings by $0.10 to $0.15 per diluted share. The Company reported revenues of $14.190 billion in fiscal 2012. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $3.71 billion and EPS of $1.14 for second quarter of 2013; revenue of $15.58 billion and EPS of $4.65 for fiscal 2013. Full Article
Baxter International Inc And Halozyme Therapeutics Inc Announces Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In European Union
Baxter International Inc and Halozyme Therapeutics Inc announced that European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies.The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC. The application was based on results from a phase III, prospective, open-label, non-controlled design clinical trial, which evaluated the safety and effectiveness of HyQvia in prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of study was to infuse a 3-or 4-week dose of the therapy in a single subcutaneous site. The acute serious bacterial infection rate in the study was 0.025 per patient per year, which is below required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In tolerability assessment of HyQvia, the frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions). Upon receiving marketing authorization from the European Commission, Baxter plans to launch HyQvia in selected countries in European Union later this year. Full Article
Ipsen SA and Inspiration Biopharmaceuticals Inc Announce Closing of OBI-1 to Baxter International Inc
Ipsen SA and Inspiration Biopharmaceuticals Inc (Inspiration) announced the closing of the sale of Ipsen SA's lead hemophilia program, OBI-1 to Baxter International Inc (Baxter). The transaction was announced on January 24, 2013. Ipsen SA and Inspiration jointly agreed to sell their respective rights to OBI-1 as part of the transaction. Baxter acquired worldwide rights to OBI-1, a recombinant porcine factor VIII in development for the treatment of congenital hemophilia A with inhibitors and acquired hemophilia A, as well as Ipsen SA's manufacturing facility for OBI-1 in Milford, Massachusetts. The Ipsen SA' employees working on the development and manufacturing of OBI-1 are offered employment by Baxter. Baxter has agreed to pay USD 50.00 million upfront, up to USD 135.00 million in potential additional development and sales as well as tiered net sales payments ranging from 12.5% to 17.5% of OBI-1 global net sales. Full Article
Baxter International Inc Issues FY 2013 Revenue Guidance In Line With Analysts' Estimates-Conference Call
Baxter International Inc announced that for fiscal 2013, it expects sales growth of approximately 10%. The Company reported revenues of $14.190 billion in fiscal 2012. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $15.619 billion for fiscal 2013. Full Article
Baxter International Inc Declares Quarterly Dividend
Baxter International Inc announced that the Board of Directors declared a quarterly dividend of $0.45 per Baxter common share. The dividend is payable on April 1, 2013 to shareholders of record as of March 8, 2013. Full Article
Baxter International Inc Issues Q1, FY 2013 Guidance
Baxter International Inc announced that for first quarter of 2013, it expects sales growth of approximately 2% to 3%, excluding the impact of foreign currency. The Company expects earnings of $1.03 to $1.05 per diluted share (EPS), before any special items. For fiscal 2013, including Gambro AB acquisition, it expects sales growth of approximately 10%, before the impact of foreign exchange. Also, the Company expects earnings of $4.60 to $4.70 per diluted share, before any special items, and cash flows from operations of approximately $3.3 billion. The Company reported revenue of $14.164 billion in fiscal 2012. Full Article
Ipsen SA and Inspiration Biopharmaceuticals Enter into an Asset Purchase Agreement with Baxter International Inc on OBI-1
Ipsen SA and Inspiration Biopharmaceuticals Inc. (Inspiration) announced they entered into an Asset Purchase Agreement (APA) whereby Baxter International Inc (Baxter) agrees to acquire the worldwide rights to OBI-1, a recombinant porcine factor VIII (rpFVIII) in development for congenital hemophilia A with inhibitors and acquired hemophilia A, and Ipsen SA’s industrial facility in Milford (Boston, MA). Under the terms of the APA, Baxter has agreed to pay USD 50 million upfront, up to USD 135 million in potential additional development and commercial milestones as well as tiered net sales payments ranging from 12.5% to 17.5% of OBI-1 annual net sales. The sale process for IB1001, a recombinant factor IX (rFIX) for the treatment and prevention of bleeding in patients with hemophilia B is separate and in the final bidding stage. Full Article
Baxter International Inc Posts Positive Results From Late Stage Hemophilia Study-Reuters
Reuters reported that Baxter International Inc reported positive results from a late-stage study evaluating routine use of its anti-inhibitor coagulant complex to treat hemophilia, a rare genetic blood clotting disorder. The data will form the basis of a biologics license application to be filed with the U.S. health regulators in the first quarter of 2013. The Phase 3 clinical trial investigated the efficacy, safety and health-related quality of life benefits of its so-called anti-inhibitor coagulant complex prophylactic treatment given to maintain health and prevent bleeds compared with on-demand treatment. The study included 36 patients with hemophilia A or B and inhibitors over a 12-month period. There was a 72.5% reduction in bleed rates for the prophylactic treatment group. The most commonly reported negative side effects in the study were hypersensitivity, dizziness, headache, rash, hypotension and hepatitis B surface antibody positive laboratory test result. Full Article
Baxter's Alzheimer's disease drug fails in late-stage trial
NEW YORK - In a blow for Alzheimer's patients, Baxter International Inc said it will scrap late-stage trials of its antibody treatment for the disease after the drug failed to improve cognitive decline and functional ability in patients.
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