BAX 817 / Takeda - LARVOL DELTA

Baxter's BAX 817 tests positive for hemophilia treatment (Zacks) - "Following the release of this positive data [from Phase III clinical trial evaluating BAX 817]...shares of Baxter climbed 0.6% to close at $67.36 the same day. Shares continued their uptrend the next day as well and rallied 1.6% to close trading at $68.43....Baxter expects an FDA approval for [BAX 855 for the treatment of hemophilia A]...in 2015. Currently, Baxter is continuing with its pediatric studies on BAX 855, upon completion of which, it expects to file for marketing authorization with the European Medicines Agency in 2016."

Anticipated BLA • Anticipated EU regulatory • Stock price • Hemophilia

Earnings roundup: Baxter international grows ahead of its spin-off (The Motley Fool) - "Baxter is working on a number of intriguing therapies and products, including BAX 111 for von Willebrand disease, which Baxter expects to file with the FDA for approval this year. And Baxter also has hemophilia treatment BAX 817 in phase 3 trials, which it hopes to file for approval in 2015. If so, BAX 817 will compete in a market valued at $1.7 billion."

Anticipated BLA • Hemophilia

Preclinical immunogenicity assessment of Baxter`s recombinant factor VIIa (ASH 2011) - Presentation Time: Monday, December 12, 2011, 6:00 PM-8:00 PM; All mice were treated with 8 weekly doses of either Baxter`s rFVIIa BAX 817 or a licensed recombinant FVIIa product; Total anti-FVIIa antibodies were analyzed prior to the first dose as well as after the 4th & the 8th dose using ELISA assays; Baxter`s rFVIIa BAX 817 & a licensed recombinant FVIIa product have a comparable immunogenic safety profile

Preclinical-animal • Hemophilia

Baxalta: Q3 2015 Results (Baxalta) - Anticipated launch in US for hemophilia during 2018-2020 

Anticipated launch US • Hemophilia

Baxter BioScience announces positive phase III results for BAX 817, investigational recombinant treatment for hemophilia A and B patients with inhibitors (Baxter Press Release) - P3, N=40; Sponsor: Baxter; NCT01757405; "The trial met its primary endpoint of successful resolution of acute bleeding episodes at 12 hours with both on-demand treatment regimens, dosing either 3x90 µg/kg or 1x270 µg/kg, with an overall success rate of 92 percent (98 percent and 85 percent in each dosing group, respectively)....Full data from the trial, including additional efficacy and safety outcomes, will be presented at a medical meeting later in 2015. The company plans to initiate regulatory submissions aligned to manufacturing expansions currently underway."

Anticipated P3 data • Anticipated regulatory • P3 data • Hemophilia