Nov. 13, 2013, 10:02 AM
- Baxter (BAX +0.3%) completes enrollment in a Phase 3 trial for the investigational extended half-life rFVIII hemophilia A treatment BAX 855.
- The study will evaluate BAX 855's efficacy in terms of reducing ABR "in both prophylaxis and on-demand treatment schedules."
- BAX says that while it is "focused first and foremost on strategies to address optimal efficacy and minimize patients bleeding episodes," the company is also "delivering on the convenience of less frequent dosing for this population with severe disease."
- The company expects to file for approval "late in 2014." (PR)
- For more on BAX, hemophilia, and the competitive environment, see here.
Nov. 12, 2013, 10:26 AM
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. 23, 2013, 2:49 PM
- Finally, a sell-sider comes to Baxter's (BAX -0.1%) defense amid escalating worries about competition in the hemophilia space.
- "Hemophilia is a highly nuanced condition in terms of patient-specific therapeutic regimens and requires intensive self-management," Goldman's David Roman says, noting that the firm has "undertaken a behavioral analysis to assess the dynamics around switching and the logistics involved."
- Goldman's conclusion: "Based on a review of physician office visits and a detailed patient demographic build, we think a reasonable rate of switching would approximate 10%-20% (of US Prophy patients) and could potentially reduce Baxter's 2015E EPS by 1-2%."
- BAX maintained at Conviction Buy with a price target of $80.
- More on the BAX hemophilia issue here
Oct. 18, 2013, 8:42 AM| Comment!
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)
Oct. 17, 2013, 7:05 AM
Oct. 17, 2013, 12:05 AM
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.
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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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