Thu, Apr. 23, 8:47 AM
- Baxter International (NYSE:BAX) Q1 results ($M): Total Revenues: 3,764 (-2.2%); BioScience: 1,361 (+2.4%); Medical Products: 2,403 (-4.6%); Net Income: 430 (-22.7%); EPS: 0.78 (-22.8%); Operating Earnings: 486 (-22.2%).
- Q2 Guidance: Sales Growth: (9 - 10%); EPS ex items: $0.92 - 0.96 from $0.85 - 0.90; GAAP EPS: $0.84 - 0.88 from $0.76 - 0.81.
- The separation of the two companies, Baxter International and Baxalta, is expected to happen mid-year. Management will provide a strategic update and guidance for Baxter in the afternoon of May 18 and for Baxalta the next morning, May 19.
Thu, Apr. 23, 7:04 AM
Wed, Apr. 22, 5:30 PM
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Wed, Apr. 22, 12:16 PM
Mon, Apr. 20, 7:36 AM
- Additional data from a Phase 3 trial evaluating Baxter International's (NYSE:BAX) recombinant von Willebrand Factor (rVWF), BAX 111, for the treatment of patients with von Willebrand disease (VWD) show the trial met its primary efficacy endpoint of the number of patients who achieved treatment success for control of bleeding episodes. The data were presented during an oral session at the 2015 Scientific Symposium of the Hemostasis and Thrombosis Research Society in New Orleans.
- All patients treated in the full analysis set (n=22) experienced a 100% treatment success rating based on a four-point efficacy rating scale, comparing the estimated number of infusions needed to treat the bleeding episodes to the actual number of infusions administered. The median number of infusion required to treat bleeding episodes in the study (n=192) was one. The majority of events (81.8%) were resolved with a single infusion.
- The company submitted its regulatory application to the FDA in late 2014. It is designated an Orphan Drug by both the FDA and EMA for the treatment of von Willebrand disease, the most common form of inherited bleeding disorder, occurring in one - two percent of the general population. Many patients with VWD have minor symptoms, but some experience severe bleeding similar to patients with hemophilia.
Thu, Apr. 16, 10:03 AM
- Baxter International (BAX -0.1%) submits a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare seeking approval of BAX 855, an investigational extended half-life recombinant factor VIII treatment for hemophilia A patients at least 12 years old.
- BAX 855 is based on ADVATE, the company's recombinant factor VIII launched in 2003, that contains no blood-based additives. This eliminates the potential risk of transmitting pathogens.
- The firm filed an BLA in the U.S. in late 2014.
- Previously: Baxter submits BLA for extended half-life hemophilia treatment (Dec. 1, 2014)
Wed, Apr. 15, 10:14 AM
- Coherus BioSciences (CHRS -3%) and Baxter International (BAX +0.4%) amend their August 2013 collaboration agreement pertaining to the development and commercialization of CHS-0214, a biosimilar to Amgen's (AMGN +1%) Enbrel (etanercept). Certain milestones and funding obligations have been revised and the partnership has been expanded to include select pre-commercialization activities. The revised milestone payments may increase Baxter's funding obligations by ~$12M. It also has agreed to buy Coherus common stock in a private transaction.
Thu, Apr. 2, 10:22 AM
- Baxter International (BAX +0.5%) and Lyon, France-based Laboratoire Aguettant SAA ink an exclusive license and distribution agreement for trace elements, essential micronutrients used in parenteral nutrition (PN) therapy. The agreement will allow Baxter to augment its PN portfolio with essential trace elements, including NUTRYELT concentrate solution (multi-trace element product) and SELENIUM and ZINC (single-trace element products). Financial terms are not disclosed.
- Parenteral (intravenous) nutrition is a therapy for patients who cannot ingest food orally or via an enteral tube.
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)
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Tue, Feb. 17, 10:09 AM
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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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