Wed, Apr. 1, 9:39 AM
- Baxter International (BAX -0.6%) secures CE Mark clearance for its automated peritoneal dialysis (APD) device, Homechoice Claria. The system features two-way connectivity so clinicians have visibility to monitor the patient's home dialysis treatments and adjust prescriptions accordingly. Peritoneal dialysis is a home-based therapy option for end-stage renal disease patients.
- The company plans to launch the product in select European and Asian countries in H1.
Mon, Mar. 23, 8:13 AM
- The European Commission grants Orphan Drug status to Kamada's (NASDAQ:KMDA) intravenous Alpha-1 Antitrypsin (AAT) for the treatment of Graft-versus-host disease (GvHD). The action follows the FDA's designation in October.
- If approved in Europe, AAT will have a 10-year period of market exclusivity. If approved in the U.S., its market exclusivity will be seven years.
- GvHD is a common complication following an allogeneic tissue transplant, usually stem cells, but it can apply to other forms of tissue graft. In GvHD, the leukocytes (white blood cells) in the tissue graft recognize the recipient (host) as foreign and then attack the host's body cells. It occurs in 30 - 70% of patients who undergo hematopoietic stem cell transplantation as a treatment for blood cancers.
- AAT (brand name Glassia) is currently FDA-approved for the treatment of adults with emphysema with AAT deficiency. It is distributed by Baxter International (NYSE:BAX) in the U.S., Canada, Australia and New Zealand.
- Shares are up 6% premarket on higher-than-average volume.
Fri, Mar. 13, 10:11 AM
- A Phase 3 trial assessing Baxter International's (BAX) investigational recombinant factor VIIa treatment, BAX 817, in male patients with hemophilia A or B who develop inhibitors, achieved its primary efficacy endpoint of successful resolution of acute bleeding episodes at 12 hours with both on-demand treatment regimens. The overall success rate was 92% (98% in the 3x90 ug/kg arm, 85% in the 1x270 ug/kg arm).
- In addition, 89% of patients achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.
- The company plans to present the data at a medical medical meeting this year.
- The development of inhibitors or binding antibodies to clotting factors is the biggest challenge in treating patients with hemophilia. About 25 - 30% of patients develop them, which can result in life-threatening complications in difficult-to-treat bleeding episodes.
Mon, Mar. 9, 8:34 AM
- Small cap CTI BioPharma (NASDAQ:CTIC) jumps 19% premarket on robust volume in response to its announcement of positive results in a Phase 3 clinical trial evaluating Fast Track-designated pacritinib in patients with primary or secondary myelofibrosis, a rare bone marrow cancer. The study met its primary endpoint, the proportion of patients achieving a 35% reduction in spleen volume from baseline at Week 24, in the intent-to-treat population with statistically significant activity in patients irrespective of their initial platelet count, including those with thrombocytopenia, a severe and life-threatening condition.
- Pacritinib is an oral tyrosine kinase inhibitor (TKI) with activity against two key activating mutations: Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). The JAK family of enzymes plays an essential role in normal blood cell growth and the development of inflammatory and immune responses. Activated JAK2 mutations are implicated in certain blood cancers, including leukemia.
- Consultant Hematologist Claire Harrison, M.D., says, "Despite the introduction of JAK2 inhibitors as effective therapies for patients with myelofibrosis, there remains a treatment gap for patients with disease-related or treatment-emergent thrombocytopenia. Results from [this study] demonstrate that pacritinib could address this unmet medical need."
- Pacritinib is currently being evaluated in two Phase 3 studies that will support a New Drug Application (NDA) filing. It is being co-developed with Baxter International (NYSE:BAX). CTIC retains exclusive commercialization rights in the U.S. while Baxter has exclusive rights ex-U.S.
Wed, Mar. 4, 9:27 AM
- Baxter International (NYSE:BAX) acquires Martinsried, Germany-based SuppreMol for €200M ($225M). The privately-held firm develops protein therapeutics for autoimmune, inflammatory and allergic diseases.
- Its lead product candidate is SM101, currently in Phase 2 development for the treatment of primary immune thrombocytopenia and systemic lupus erythematosus. SM101 is a modulator of Fc gamma receptor IIB, a key protein in the signalling pathway that could have broad applications in autoimmune disorders.
Fri, Feb. 27, 9:59 AM
- Biogen Idec (BIIB -0.5%) and collaboration partner Swedish Orphan Biovitrum AB announce positive top-line results from a Phase 3 trial evaluating Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein) in children under age 12 with severe hemophilia B.
- Medical professionals recommend prophylactic treatment in children with severe hemophilia in order to manage and/or prevent bleeding episodes, but frequent administration schedules can be burdensome for patients and caregivers. Alprolix is administered once every 7 - 10 days for routine prophylaxis (prevention).
- In the study, children treated with Alprolix experienced an overall median annualized bleeding rate (ABR) of 1.97, while the median ABR for spontaneous joint bleeds was zero. About one third of the participants had no bleeding episodes at all. Overall, 91.7% of bleeding episodes were controlled by one or two infusions of Alprolix. None of the patients produced inhibitors (antibodies) to Alprolix in the study, which was the most significant potential complication of treatment.
- The European Medicines Agency requires the inclusion of pediatric study data in the initial Marketing Authorization Application (MAA) for a new hemophilia treatment. Interim data were used in the U.S. New Drug Application (NDA).
- Alprolix is the only approved hemophilia B therapy with prolonged circulation in the body. The FDA cleared it in March of last year. It generated $25.3M and $40.3M in sales for Biogen in Q3 and Q4, respectively.
- Related tickers: (BAX +0.3%)(OPK -0.8%)(SGMO -1.9%)(ALNY -1.9%)(ONCE +3%)(PFE -0.2%)(SHPG -1.6%)
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Tue, Feb. 17, 10:09 AM
Thu, Feb. 12, 5:10 PM
- The Phase 1/2 open label safety and optimal dosing trial evaluating Baxter International's (NYSE:BAX) gene therapy candidate, BAX 335, for the treatment of hemophilia B showed none of the six patients dosed to date developed Factor IX (FIX) inhibitors, although two from the highest dose cohorts exhibited FIX activity of ~10%.
- The trial will enroll up to 16 adult patients with hemophilia B to determine the safety of ascending doses of BAX 335 and the optimal single dose. The primary endpoint is the safety of a single dose of BAX 335 administered intravenously.
- As of the end of 2014, six patients in three dosing cohorts have been treated with evidence of a dose-related response. In addition to the two patients cited earlier, one showed elevated levels of liver enzymes which indicates an immune response. The patient is being treated with corticosteroids, per protocol. An immune response is a serious adverse event since it could lead to serious illness or even death.
- The clinical evaluation of BAX 335 is ongoing. The company is also advancing plans to evaluate the gene therapy technology in hemophilia A.
Fri, Jan. 30, 12:31 PM
- Opko Health (OPK +3.5%) submits an Investigational New Drug Application (IND) to the FDA for clearance to commence a Phase 2a study evaluating its long-acting Orphan Drug-designated coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VII or Factor IX.
- Currently, Factor VIIa therapy is administered intravenously which requires multiple infusions, due to its short half-life, to treat a bleeding episode.
- The longer duration of action of Opko's Factor VIIa-CTP is based on the naturally occurring peptide, C-terminal peptide, of the beta chain of human chorionic gonadotropin (hCG).
- Opko acquired the rights to the product when it bought Prolor Biotech.
- Previously: Opko completes its acquisition of Prolor Biotech (Aug. 29, 2013)
- Related tickers: (BAX +0.4%)(SGMO +0.6%)(ALNY +0.5%)(BIIB +11.4%)(OTCPK:BAYRY -1.4%)
Thu, Jan. 29, 7:33 AM
- Baxter International (NYSE:BAX) Q4 results ($M): Total Revenues: 4,472 (+3.5%); U.S.: 1,887 (+6.0%); Intl: 2,585 (+1.7%); BioScience: 1,880 (+8.7%), U.S.: 951 (+6.7%), Intl: 929 (+10.7%); Medical Products: 2,592 (0.0%), U.S.: 936 (+5.2%), Intl: 1,656 (-2.7%).
- BioScience: Hemophilia: 1,055 (+8.5%); BioTherapeutics: 628 (+11.3%); BioSurgery: 197 (+1.5%); Vaccines: 34 (-26.1%).
- Medical Products: Fluid Systems: 822 (+0.4%); Renal: 1,082 (-1.5%); Specialty Pharma: 417 (+2.5%); BioPharma: 271 (+1.5%).
- COGS: 2,248 (-3.4%); R&D Expense: 335 (-15.4%); SG&A Expense: 1,091 (+3.5%); Net Income: 953 (+192.3%); EPS: 1.74 (+194.9%); CF Ops: 1,143 (+5.5%).
- Gross Profit: 2,224 (+11.4%); COGS: 50.3% (-6.6%); Gross Margin: 49.7% (+7.7%); Operating Earnings: 798 (+46.2%); Operating Earnings Yield: 17.8% (+41.3%); Net Earnings Yield: 21.3% (+182.5%).
- Q1 Guidance: Sales Growth: (3 - 4%); EPS ex. items: $0.85 - 0.90; GAAP EPS: $0.76 - 0.81.
Thu, Jan. 29, 7:05 AM
Wed, Jan. 28, 5:30 PM
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Tue, Jan. 20, 10:14 AM
- The FDA approves Baxter International's (BAX -0.1%) Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0) as replacement solutions in patients with acute kidney injury who are undergoing continuous renal replacement therapy (CRRT) to correct electrolyte and acid-base imbalances and, in the case of drug poisoning, when CRRT is used to remove dialyzable substances.
- Phoxillum is the only FDA approved premixed solution containing phosphate. Hypophosphatemia (low blood phosphate) is a common electrolyte problem in patients treated with CRRT.
- The company expects to launch Phoxillum phosphate-containing solutions in Q2.
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.
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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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