Sep. 15, 2014, 8:08 AM| Comment!
Sep. 13, 2014, 1:26 PM
- The FDA approves Baxter International's (NYSE:BAX) Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of adult patients with primary immunodeficiency (PI).
- Hyqvia's value proposition is less frequent dosing and fewer infusion sites. Patients require only one infusion of Hyqvia every three of four weeks delivered via one injection site. Most PI patients require weekly or bi-weekly infusions delivered via multiple injection sites.
- It is the first BLA approved in the U.S. that utilizes Halozyme's (NASDAQ:HALO) rHuPH20 platform. It was approved in Europe last year for the treatment of PI syndromes and myeloma or chronic lymphocytic leukemia with severe seconday hypogammaglobulinemia and recurrent infections.
- Hyqvia consists of a 10% solution of IgG prepared from pooled human plasma. This provides the therapeutic effect. The Recombinant Human Hyaluronidase increases the dispersion and absorption of IgG.
- Baxter intends to launch Hyqvia in the U.S. in the next few weeks.
Sep. 10, 2014, 4:59 PM| 7 Comments
Aug. 21, 2014, 10:01 AM
- In a 138-patient Phase 3 clinical trial evaluating the safety and efficacy of Baxter International's (BAX +0.9%) BAX 855, an extended half-life recombinant factor VIII (rFVIII) for the treatment of hemophilia A, the product candidate met its primary endpoint of reducing annualized bleed rates (ABR) in the prophylaxis arm versus the on-demand arm.
- Patients in the twice-weekly prophylaxis arm experienced a 95% reduction in median ABR compared to the on-demand group (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes considering that 96% were controlled with one or two infusions.
- The half life of BAX 855 was 1.4x - 1.5x that of Advate [antihemophilic factor (recombinant)].
- The company expects to submit its BLA for BAX 855 before the end of 2014.
Aug. 4, 2014, 10:18 AM
- The U.S. regulator approves Baxter International's (BAX -1%) Flexbumin 5% Solution indicated for hypovolemia, hypoalbuminemia due to general causes, burns and in patients undergoing cardiopulmonary bypass surgery.
- The 5% solution complements the company's current offering of a 25% solution in 50 ml and 100 ml sizes. It will be commercially available later this year.
Jul. 31, 2014, 2:17 PM
- The FDA's Blood Products Advisory Committee votes 15-1 supporting the risk/benefit profile of Baxter's (BAX -1.7%) HyQvia [Immune Globulin 10% (Human) with Recombinant Human Hyaluronidase].
- The product was approved in Europe in 2013 for the treatment of adult patients with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobinemia and recurrent infections.
- The company expects an FDA decision this quarter.
- Related ticker: (HALO +6.2%)
Jul. 30, 2014, 9:35 AM
- Pfizer (PFE -1.7%) enters into a definitive agreement to acquire Baxter International's (BAX +0.7%) vaccine business for $635M. The transaction includes a portion of Baxter's manufacturing facility in Orth, Austria.
- The deal is expected to close by the end of 2014. Pfizer says that it will not impact its guidance for the year.
Jul. 29, 2014, 1:23 PM
- The FDA's Blood Products Advisory Committee meets on Thursday, July 31, 2014 to discuss Baxter International's (BAX +0.3%) BLA for HyQvia (Immune Globulin 10%) for the treatment for adult patients with primary and secondary immunodeficiencies. The European Commission cleared the product in May 2013.
- Related ticker: (HALO -0.9%)
- Briefing book
Jul. 22, 2014, 9:03 AM
Jul. 17, 2014, 8:10 AM
- Baxter International (NYSE:BAX) Q2 results: Total Revenues: $4,264M (+16.2%); BioScience: $1,751M (+6.9%); Medical Products: $2,513M (+23.7%).
- Bioscience Revenues: Hemophilia: $904M (+6.5%); BioTherapeutics: $548M (+6.8%); BioSurgery: $189M (+6.2%); Vaccines: $110M (+12.2%).
- Medical Products Revenues: Fluid Systems: $816M (+8.1%); Renal: $1,044M (+59.6%); Specialty Pharma: $404M (+10.4%); BioPharma Solutions: $249M (-2.7%).
- COGS: $2,041M (+5.3%); R&D Expense: $325M (+19.0%); SG&A Expense: $998M (+19.1%); Net Income: $520M (-11.9%); EPS: $0.95 (-11.2%); CF Ops: $599M (-21.5%). Gross Profit: $2,041M (+5.3%); COGS: 52.1% (+10.6%); Gross Margin: 47.9% (-9.4%); Operating Profit: $718M (-13.3%); Operating Earnings Yield: 16.8% (-25.4%); Net Earnings Yield: 12.2% (-24.2%).
- 2014 Guidance: Sales Growth: 10 - 11% up from 9 - 10%; EPS ex items: $5.10 - 5.20 versus $5.05 - 5.25; CF Ops: ~$3.5B (unch).
- Press release
Jul. 17, 2014, 7:04 AM
Jul. 16, 2014, 5:30 PM
Jul. 9, 2014, 9:16 AM
- Baxter International (BAX) acquires AesRx LLC, a private biopharmaceutical company focused on orphan drug targets. Its lead product candidate, currently in Phase 2, is Aes-103 (5-hydroxymethylfurfural) a small molecule compound being investigated as a prophylactic treatment for sickle cell disease. Financial terms are not disclosed.
Jul. 7, 2014, 9:51 AM
- Baxter International (BAX +0.3%) CFO Robert J. Hombach departs to assume senior operational responsibilities at the recently-spun-out biopharmaceuticals business. He will report to CEO Ludwig N. Hantson, Ph.D. Former Baxter treasurer James K. Saccaro rejoins the firm as CFO from Hill-Rom where he was SVP and CFO.
Jul. 1, 2014, 7:23 AM
- CTI BioPharma (CTIC) completes enrollment in the PERSIST-1 Phase 3 clinical trial of pacritinib, an oral JAK2/FLT3 inhibitor being evaluated as a treatment for myelofibrosis. Under the terms of the development and commercialization agreement with Baxter International (BAX), CTI expects to receive a $20M milestone payment when the last patient in the trial begins dosing. The payment should occur this quarter.
- There are approximately 320 patients enrolled in PERSIST-1. It is a randomized, open-label multicenter study comparing the safety and efficacy of pacritinib with best available therapy, other that JAK inhibitors, in patients with primary myelofibrosis without exclusion for low platelet counts. The primary endpoint is the percentage of patients achieving at least a 35% reduction in spleen volume measured by MRI or CT at 24 weeks of treatment.
May 19, 2014, 10:22 AM
- The U.S. Supreme Court declines to hear an appeal by Baxter International (BAX -0.1%) in a dialysis machine patent suit with Fresenius Medical Care (FMS -0.7%). The issue is whether a court can throw out a patent infringement judgement in a case where the patent office decides that a patent is invalid while the litigation is in process. The court's action means that the July 2013 ruling by the U.S. Court of Appeals remains intact whereby it threw out a $24M judgment in favor of Baxter.
- Biotech and pharma industry groups urged the court to hear the case because the appeals court ruling creates uncertainty due to the encouragement of time-wasting dual-track litigation.
- Fresenius originally challenged the Baxter patent in 2003. Baxter counter-sued and won a judgement in 2012 that required the former to pay for infringement. During the litigation, Fresenius asked the patent office to reconsider the validity of the patent which it did in 2010.
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Baxter International Inc is a healthcare company. It develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma and other chronic conditions.
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