Thu, Jan. 8, 7:55 PM
- The FDA approves Daiichi-Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
- Edoxaban is an anticoagulant that inhibits factor Xa. It was approved in Japan in 2011 for the prevention of venous thromboembolism in patients undergoing total knee replacement surgery, total hip replacement surgery and hip fracture surgery.
- Anticoagulant-related tickers: (NASDAQ:ISIS) (NYSE:BAX) (NASDAQ:PTLA) (NASDAQ:MSLI) (NYSE:MRK) (NYSE:JNJ) (NASDAQ:MDCO) (NASDAQ:SCLN) (NYSE:PFE) (NYSE:BMY) (NYSE:AZN) (OTCPK:BAYRY)
Dec. 22, 2014, 11:10 AM
- Baxter International (BAX +0.6%) submits a Biologics License Application (BLA) to the FDA for BAX111, a highly-purified recombinant von Willebrand Factor (rVWF), for the treatment of von Willebrand disease, the most common form of inherited bleeding disorder.
- Both the FDA and EMA have designated the product candidate an Orphan Drug for the indication. If approved, it will have a seven-year period of exclusivity in the U.S. and ten years in the European Union.
Dec. 17, 2014, 4:50 PM
Dec. 15, 2014, 10:48 AM
- Baxter International (BAX) sells its Vero cell technology, related assets and its production facility in the Czech Republic to Alachua, FL-based Nanotherapeutics for an undisclosed sum. The transaction includes the assets related to vaccines for H5N1, H1N1, seasonal influenza as well as the investigational programs for Ross River virus, Chikungunya disease and West Nile virus.
- The Vero cell platform is an advanced cell-based technology for vaccines production.
Dec. 1, 2014, 9:51 AM
- Baxter International (BAX -0.4%) submits a biologics license application (BLA) to the FDA for BAX 855, an investigational extended half-life recombinant factor VIII treatment for hemophilia A based on Advate [Antihemophilic Factor (Recombinant)].
- The submission is based on the results from a Phase 3 trial of of 137 previously-treated patients. Patients in the twice-weekly prophylaxis arm experienced a 95% reduction in median annual bleed rate (ABR) compared to the on-demand arm. Also, 96% of bleeding episodes were controlled with one or two infusions.
- The company expects to present additional data from the trial in the coming months. The separate Phase 3 study in patients under the age of 12 with severe hemophilia is ongoing. After it concludes, Baxter expects to file a marketing authorization application (MAA) in Europe sometime in 2016.
Dec. 1, 2014, 8:10 AM
- Pfizer (NYSE:PFE) finalizes its buy of Baxter International's (NYSE:BAX) NeisVac-C (meningitis - MenC) and FSME-IMMUN/TicoVac (tick-borne encephalitis) vaccines and a portion of Baxter's facility in Orth, Austria where the products are made. The $635M deal was announced in late July.
- Previously: Pfizer buys Baxter's vaccine business
Nov. 11, 2014, 9:09 AM
Oct. 24, 2014, 9:21 AM
- The FDA approves Baxter International's (NYSE:BAX) Orphan Drug-designated Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), a very rare and potentially life-threatening acute bleeding disorder.
- Orbizur is the first recombinant procine FVIII treatment approved for AHA that allows physicians to manage treatment by measuring factor VIII activity levels in addition to clinical assessments.
- Among the benefits of the Orphan Drug tag is a seven-year period of marketing exclusivity following regulatory approval.
Oct. 16, 2014, 8:16 AM
- Baxter International (NYSE:BAX) Q3 results ($M): Total Revenues: 4,251 (+12.6%); U.S.: 1,755 (+6.9%); International: 2,442 (+14.5%); BioScience: 1,673 (+3.3%); Medical Products: 2,524 (+17.2%); Vaccines: 54 (-15.6%).
- BioScience: Hemophilia: 942 (+10.7%); BioTherapeutics: 546 (+2.6%); BioSurgery: 185 (+6.9%); Vaccines: 54 (-15.6%).
- Medical Products: Fluid Systems: 827 (+4.4%); Renal: 1,055 (+41.4%); Specialty Pharma: 386 (+3.8%); BioPharma Solutions: 256 (+4.9%).
- COGS: 2,124 (+16.2%); R&D Expense: 455 (+56.9%); SG&A Expense: 1,040 (+5.7%); Net Income: 468 (-14.0%); EPS: 0.86 (-13.1%); CF Ops: 914 (-5.4%).
- Gross Profit: 2,127 (+9.3%); COGS: 50.0% (+3.2%); Gross Margin: 50.0% (-3.0%); Operating Profit: 632 (-6.0%); Operating Earnings Yield: 14.9% (-16.5%); Net Earnings Yield: 11.0% (-23.6%).
- 2014 Guidance: Sales growth: unch; EPS ex items: $4.86 - 4.89 from $5.10 - 5.20; CF Ops: unch.
Oct. 16, 2014, 7:03 AM
Oct. 15, 2014, 5:30 PM
Oct. 6, 2014, 1:55 PM
- Privately-held Danbury, CT-based Perosphere enters into a third collaboration agreement with Daiichi Sankyo to study PER977, Perosphere's investigational anticoagulant reversal agent, in Phase 3 trials with edoxaban, Daiichi's investigational oral, once-daily factor Xa-inhibitor.
- In Phase 1 and 2 studies, PER977 showed that it directly binds to heparin as well as circulating direct factor Xa- and IIa-inhibitors reversing their anticoagulant effect. PER977 does not bind to blood coagulation factors or other blood proteins. In healthy volunteers, it reverses anticoagulant activity after a single IV dose of 100 mg - 300 mg and does not require an extended infusion in order to maintain the reversal.
- Under the terms of the agreement, Perosphere will seek FDA and EMA approval of PER977 to reverse anticoagulant activity of edoxaban and commercialize PER977 in the U.S. and EU. It retains full worldwide commercial rights to PER977. Perosphere will receive an upfront payment from Daiichi Sankyo as well as clinical development-related milestones. It plans to submit an NDA to the FDA by June 2015.
- Related tickers: (JNJ -0.4%)(OTCPK:BAYRY -0.4%)(OTCPK:BAYZF +0.1%)(PFE -0.3%)(BAX)(BMY -0.3%)(ISIS -1.9%)(PTLA)(AZN -0.1%)(MRK -0.6%)
Oct. 3, 2014, 10:55 AM
- Shares of thinly-traded small cap Rockwell Medical (RMTI +17.3%) jump on a 4x surge in volume in response to its exclusive agreement with Baxter International (BAX +1.3%) to commercialize Rockwell's hemodialysis concentrate product line in the U.S. and selected ex-U.S. markets.
- Under the terms of the agreement, Baxter will be the exclusive distributor of Rockwell's hemodialysis concentrate and ancillary products in the selected territories an an initial term of 10 years. Baxter can extend the agreement for two additional five-year terms if it meets certain sales targets and pays Rockwell $7.5M for the first extension. It must also meet minimum annual purchase levels in order to maintain exclusivity.
- In consideration of exclusivity, Baxter will pay Rockwell $20M in cash and purchase $15M in RMTI stock at $11.39 per share. Rockwell is eligible to receive milestone payments up to $10M for the expansion of its manufacturing capabilities to serve U.S. customers.
Sep. 29, 2014, 1:56 PM
- Kamada (KMDA -0.1%) extends its agreement to supply its liquid alpha-1 antitrypsin (AAT) treatment, Glassia, to Baxter International's (BAX -0.6%) biopharmaceutical unit through 2017.
- The extension secures an additional $26M in revenues for Kamada bringing the total contract minimum up to $191M.
- The transition to royalty payments for Glassia produced by Baxter is not expected to begin before 2018. Baxter is the exclusive distributor of Glassia in the U.S., Canada, Australia and New Zealand.
Sep. 25, 2014, 5:35 PM
Sep. 25, 2014, 4:22 PM
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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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