Baxter International Inc.
) revealed that it has completed enrolling patients in its Phase
III PROLOG-ATE clinical trial evaluating the efficacy of BAX 855,
an extended half-life, recombinant factor VIII (rFVIII) protein
used for hemophilia A treatment. Following the announcement of
the news, BAX shares moved up 2.6% to $67.60 on Nov 14.
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Built on the same protein used in Advate [Antihemophilic Factor
(Recombinant) Plasma/Albumin-Free Method], BAX 855 has been
modified to include the PEGylation technology from
). The PEGylation technology is designed to extend the duration
of activity of proteins in the body.
This pivotal trial intends to study the efficiency of the BAX 855
compound in lowering annualized bleed rates (ABR) when
administered on prophylaxis and on-demand treatment schedules.
Additionally, the trial will also assess its safety and
pharmacokinetic profile. Management claims that no inhibitors or
safety issues have been registered till date.
Upon successful completion of the trial, Baxter intends to file
for regulatory approvals in late 2014 and plans to start a
continuation study for all patients who will complete the Phase
II/III study. Moreover, the company also plans to initiate a BAX
855 study among pediatric patients in 2014.
The Phase I trial analyzed the safety, tolerability and
pharmacokinetics of the BAX 855 compound. Results demonstrated
that the duration of activity of the drug in the body was roughly
1.5 times higher than the Advate. Moreover, no adverse clinical
events were reported during the course of the trial.
Baxter's BioScience business processes recombinant and
plasma-based proteins to treat hemophilia. Milestone achievement
for pipeline products represents a significant opportunity for
top-line growth for BAX.
In the last reported quarter, revenues from the BioScience
segment increased 6% year over year to $1.6 billion. Hemophilia,
the largest sub-unit, generated revenues of $851 million, up 9%
from the prior-year quarter. Growth was driven by higher demand
for Advate used in Hemophilia and Feiba, along with benefits from
apt timings of international tenders.
Currently, Baxter carries a Zacks Rank #3 (Hold). Stocks that are
performing relatively better in the medical products industry
Hill-Rom Holdings, Inc.
). Both of them carry a Zacks Rank #1 (Strong Buy).