Oct. 16, 2013, 5:30 PM
Oct. 16, 2013, 1:15 PM
- "Snapping up market share in bleeding disorders won't be easy," Fierce Biotech's Tracy Staton notes, regarding FDA BLA approval for Novo Nordisk's (NVO +1.7%) NovoEight.
- Entrenched competitors in the hemophilia market include Baxter (BAX) — whose market position could come under pressure in the future thanks to competition from Biogen's (BIIB) long-acting clotting factor therapies (see here and here) — and Pfizer (PFE).
- Nevertheless, "NovoEight's approval is a step toward replacing [expected] lost revenues" from NovoSeven.
- Other relevant info cited by Staton: In June, the FDA "refused to approve rFXIII ... for the rare bleeding disorder congenital factor XIII deficiency [citing] problems with NVO's manufacturing, and last year, the drugmaker canned another potential entry in hemophilia, vatreptacog alfa, after some patients developed antibodies to the treatment."
Oct. 14, 2013, 1:15 PM
- "We were already well below Street views," Citi's Matthew Dodds notes, cutting his estimates for Baxter (BAX +0.3%) further after "including more specific modeling of the margin hit" from generic Suprane and Endoxan.
- Citi's target is now $70 (from $75).
- Dodds' new estimates also include the Gambro acquisition.
Oct. 13, 2013, 2:59 AM
- California Governor Jerry Brown has vetoed a bill that would have limited the use of biosimilar pharmaceuticals in the state.
- Brown explained that the legislation was premature, as the FDA hasn't yet set the rules governing such drugs.
- Biosimilars are the copycat versions of biotech drugs - also known as biologics - which are complex proteins developed in living cells. Biosimilars are not called generics, as it's difficult to prove that they're exactly the same as the biologic original.
- The campaign to limit the use of biosimilars has been led by Amgen (AMGN) and Genentech (RHHBY.OB); so far, 10 states have blocked such efforts this year, including Illinois and Texas.
- Companies developing biosimilars include Hospira (HSP), Novartis (NVS), Momenta Pharmaceuticals (MNTA), Baxter (BAX) and Teva (TEVA).
- Healthcare ETFs: XLV, XHE, VHT, FXH, IHF, IHI, IYH, PTH, RYH, PSCH, RXL, RXD, XHS
Oct. 11, 2013, 9:13 AM
- Jefferies' Thomas Wei lifts his price target on Biogen (BIIB) to $270 from $266 citing encouraging feedback on the "expected launches of new long-acting hemophilia factors."
- Positive comments from JPMorgan on the long-lasting clotting factor therapy Eloctate sank shares of Baxter (BAX) late last month.
Oct. 4, 2013, 2:03 PM| Comment!
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.
Sep. 6, 2013, 12:29 PM
- Baxter (BAX +0.7%) has completed its acquisition of Gambro, a privately held global medical technology company based in Lund, Sweden.
- The total price tag on the deal was $3.9B, which was included in its Q3 and FY13 guidance.
- The acquisition gives BAX the opportunity to build upon its core portfolio and pipeline of investigational home hemodialysis and automated PD systems by adding Gambros dialyzers, devices and dialysis solutions, next-generation monitors, and acute therapies to treat patients with serious kidney, liver and lung conditions.
Aug. 13, 2013, 8:00 AM
- China's Ministry of Commerce has authorized Baxter's (BAX) $4B acquisition of Sweden's Gambro on the condition that Baxter divests its global continuous renal replacement therapy business, which accounts for 2% of its renal product sales.
- The EU also demanded the sale of the unit when it approved the Gambro deal.
- As part of the authorization in China, Baxter must end an outsourcing production deal in the country with Japan's Nipro by March 31, 2016.
Jul. 31, 2013, 10:12 AM
- Baxter (BAX -0.1%) enters into an exclusive distribution and license agreement with JW Holdings for parenteral nutritional products containing a formulation of omega 3 lipids.
- Under the terms of the agreement, BAX will have exclusive rights to co-develop and distribute the products globally, with the exception of Korea.
- The arrangement includes a $25M up-front payment that will be recorded as a special pre-tax in-process R&D charge in Q3, as well as payments totaling up to $10M for the achievement of certain regulatory milestones, along with royalties on future product sales.
Jul. 23, 2013, 5:49 PM
Jul. 22, 2013, 7:51 AMBaxter (BAX) is reportedly being investigated for potential malpractice at its Chinese JV, Baxter Qiaoguang Pharmaceutical. The probe could relate to payments made to ensure that Baxter's ClinOleic treatment is on the list of products that can be claimed on national insurance in China. The inquiry adds to the investigation into GSK and a possible probe into AstraZeneca. | Comment!
Jul. 18, 2013, 8:04 AMMore on Baxter's (BAX) Q2: Global sales rise 3% Y/Y reflecting 3% revenue growth in the U.S. and internationally. Bioscience revenues come in at $1.6B, up 5% Y/Y as the company says demand for Advate and FEIBA is strong. Medical products revenues manage a 1% Y/Y gain (2% ex-currency impact) driven by "gains in peritoneal dialysis patients." Q3 guidance: $1.18-1.21/ share before items on sales growth of 9-12%, a figure that includes the Gambro acquisition and accounts for FX effects. For the full year, management sees EPS of $4.62-4.70 on sales growth of 7-8%. (PR) | Comment!
Jul. 18, 2013, 7:03 AM
Jul. 18, 2013, 12:05 AM
Jul. 17, 2013, 5:30 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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