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.
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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
Sep. 24, 2014, 7:34 AM
- Baxter International (NYSE:BAX) and Merrimack Pharmaceuticals (NASDAQ:MACK) enter into an exclusive license and collaboration agreement to develop and commercialize the Orphan Drug-designated MM-398 (nanoliposomal irinotecan injection), also known as nal-IRI. The initial indication will be pancreatic cancer previously treated with gemcitabine for which Merrimack is preparing an NDA for submission in 2014.
- Under the terms of the agreement, Baxter has exclusive commercial rights for all potential indications of MM-398 worldwide except the U.S. and Taiwan. Merrimack retains commercialization rights in the U.S. while the rights in Taiwan are held separately. Merrimack will receive an upfront payment of $100M, up to $120M in regulatory milestone payments related to the first pancreatic cancer indication, up to $280M in development and regulatory milestone payments for a second pancreatic cancer indication, up to $220M in development and regulatory milestone payments for two additional indications, up to $250M in sales milestone payments and tiered royalties on net sales of MM-398 in the licensed territories.
- In a Phase 3 clinical trial, MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin demonstrated a statistically significant improvement in overall survival, progression-free survival and overall response rate compared to 5-FU and leucovorin alone. This was the first positive global Phase 3 study in a post-gemcitabine setting to show a survival benefit in pancreatic cancer.
- Baxter plans to submit its regulatory applications outside of the U.S. beginning is 2015.
Sep. 15, 2014, 10:31 AM
- The FDA approves Baxter International's (BAX -0.6%) Rixubis [Coagulation Factor IX (Recombinant)] for routine the prophylactic treatment, control and prevention of bleeding episodes, and perioperative treatment, in children with hemophilia B. It was previously approved for use in adult patients with hemophilia B.
- Rixubis is currently under regulatory review in Europe for use in both adults and children. A decision is expected this year.
Sep. 15, 2014, 8:08 AM| 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| 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.
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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