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.
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.
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- Baxter International (BAX) is splitting into two companies, with one focused on biopharmaceuticals and the other on medical products.
- Baxter will make a tax-free distribution of shares in the biopharmaceuticals business to its shareholders. The company expects to complete the transaction by mid-2015.
- The biopharmaceuticals business generated 2013 annual revenues of $6B and develops treatments for hemophilia and other bleeding disorders, immune deficiencies, burns and shock.
- The medical-products business earned annual sales of over $9B and provides intravenous (IV) solutions and nutritional therapies, drug-delivery systems and administration sets, and premixed and other injectable drugs, as well as inhalation anesthetics and hospital-based biosurgery products.
- Baxter CEO Robert Parkinson will head the medical-products company, which will retain the Baxter International name.
- Ludwig Hantson, who is president of BioScience, will run the biopharmaceuticals firm. (PR)
- Shares are +12.5%.
Nov. 18, 2013, 7:39 AM
- Cell Therapeutics (CTIC) expects to spend $96M through mid-2017 on the development and commercialization of its Pacritinib treatment for myelofibrosis and acute myeloid leukemia.
- Cell Therapeutics expects to receive $67M from Baxter (BAX) in milestones until 2015 as part of a licensing agreement for Pacritinib, with further payments possible after that. Cell Therapeutics is also receiving a $60M upfront payment from Baxter. Cell Therapeutics reckons that it should receive enough money to avoid have to raise more equity financing.
- Cell Therapeutics and Baxter have been boosted by the failure of Sanofi's (SNY) Fedratinib treatment for myelofibrosis. Incyte (INCY) also develops a treatment for the rare bone-marrow cancer.
- Cell Thera is +7.5%.
Nov. 15, 2013, 10:15 AM
- Cell Therapeutics (CTIC +20.6%) soars as investors react to news the company has inked a licensing agreement with Baxter (BAX +0.9%) for the development and commercialization of pacritinib.
- As for Incyte (INCY +2.6%) — whose Jakafi also treats myelofibrosis — any downside the shares might have realized from the prospective competition appears to be taking a backseat to either a 13D filing by Baker Bros. or perhaps a price target hike at Brean.
Oct. 28, 2013, 1:49 PM
- "According to EMA documents, a review is going on regarding a potential data exclusivity decision and the agency looks likely to reach a conclusion by November. We expect the decision to be made public on November 22 after CHMP meeting," Deutsche's Robyn Karnauskas says, regarding regulatory data protection for Tecfidera in Europe. The decision will affect when the MS drug could face generic competition in the region.
- Karnauskas sees fair value of $250/share with EU exclusivity and $238/share without it — if there's no EU launch at all, Karnauskas sees $225/share. Adding in hemophilia estimates, Deutsche has a target of $270 on the shares assuming RDP for Tecfidera.
- Speaking of hemophilia, CEO George Scangos says approval for BIIB's Eloctate may be delayed. "The matter under discussion does not pertain to the safety or efficacy of the product or any of the clinical trial data," Scangos notes.
- Some analysts believe Eloctate is bad news for Baxter (BAX +2.1%) in terms of competition in the hemophilia space, although Goldman thinks the concerns are overblown.
Oct. 17, 2013, 7:48 AM
- Shares of Baxter (BAX) slip 3.8% in premarket trading as investors digest the company's quarter.
- Revenue of $3.8B is a 9% improvement from last year's quarter, although the top line fell slightly short of Street estimates (around 3% of the Y/Y growth is attributable to the Gambro acquisition).
- U.S. sales rose 9%, as did international sales.
- "Improved" demand for Advante and Feiba drove a 6% Y/Y increase in BioScience revenues
- Medical Products sales rose 10% (including Gambro).
- Outlook: Q4 sales growth of 14-15% (ex-currency impact) and EPS of $1.24-1.26 against consensus of $1.26/share on $4.31B in sales. FY13 sales growth of 7% (ex-currency impact and including Gambro) and EPS of $4.65-4.67 — the earnings outlook is consistent with previous guidance and is in line with consensus. (PR)
Sep. 25, 2013, 2:00 PM
- Shares of Baxter (BAX -6.1%) trade notably lower on heavy volume after a JPMorgan initiation at Neutral.
- Citing a survey of "50 hematologists caring for more than 15% of the U.S. market," JPM says the hemophilia drug space is set to get more competitive.
- More patients may begin switching to long-lasting clotting factor therapies like Biogen's (BIIB -0.2%) Eloctate.
- Price target is $76.
Jun. 24, 2013, 2:20 PMNeostem (NBS +5.7%) gets a boost from an upgrade at Aegis Capital with a Buy rating and a $2.50 price target. Aegis says NBS represents a unique participant in the stem cell sector, given the fact that it has four different technology platforms and a solid lead product candidate, AMR-001, which is a stem cell-based therapeutic for cardiovascular disease with tremendous potential. The drug is currently in a proof-of-concept Phase 2 trial that is slated to report data early next year, and positive results could land it a partnership with Baxter (BAX). | 2 Comments
May 7, 2013, 1:54 PM
May 7, 2013, 8:25 AM
Mar. 22, 2013, 9:29 AMHalozyme Therapeutics (HALO) +18.6% premarket after the European Medicines Agency approves partner Baxter (BAX) for the use of HALO's HyQvia as replacement therapy for adult patients with primary and secondary immunodeficiencies. Upon receiving marketing authorization from the EC, BAX plans to launch HyQvia in some European countries later this year. | Comment!
Nov. 23, 2012, 10:35 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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