A day before World Hemophilia Day,
Baxter International Inc.
) announced that its investigational von Willebrand disease (VWD)
drug known as BAX 111 met its primary efficacy endpoint in a
late-stage trial. Shares of BAX, however, fell 0.9% to close at
$72.81 till the last closing date.
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BAX reported top-line results from its Phase 3 clinical trial
evaluating the safety, efficacy and pharmacokinetics (PK) of BAX
111, a recombinant von Willebrand factor (rVWF) being studied for
the treatment of bleeding episodes in patients with VWD. BAX 111
is the first recombinant treatment in clinical development for
VWD, the most common type of inherited bleeding disorder.
BAX initiated the Phase III, open-label, clinical trial in Oct
2011 at trial sites in the U.S., Europe, Australia, Japan, Russia
and India. The trial evaluated BAX 111 administered together with
ADVATE or as a stand-alone therapeutic agent, in the on-demand
treatment of 37 patients with severe VWD.
The primary endpoint was the number of patients receiving
successful treatment for bleeding episodes. Secondary endpoints
included additional efficacy and safety measures,
pharmacokinetics and health-related quality of life (HRQoL).
According to BAX, there were no instances of inhibitor
development or thrombotic events in the participants. The most
common adverse events in the study were headache, vomiting/nausea
and anemia, which were not considered to be treatment-related.
However, chest discomfort along with an increased heart rate
during infusion was a serious adverse event associated with the
treatment. Nevertheless, the issue was rapidly resolved without
BAX expects to present full data from the late-stage trial,
including efficacy and safety outcomes, later this year. In Nov
2010, both the U.S. Food and Drug Administration (FDA) and the
European Commission (EU) granted orphan-drug designation for BAX
BAX intends to file for the U.S. approval of the drug before the
end of 2014. In this vein, based on the aforementioned trial
results, it seeks to pursue a study of BAX 111 in a prophylaxis
treatment setting before the end of the year.
On Apr 17, 2014, BAX posted a 9.2% rise in adjusted net earnings
to $1.19 per share for the first quarter of 2014, from $1.09 per
share in the same quarter last year. The bottom line also beat
the Zacks Consensus Estimate by 9 cents per share.
Revenues for the quarter went up 14.6% to $3,951 million globally
and surpassed the Zacks Consensus Estimate of $3,885 million, led
by strong growth in the BioScience and Medical Products segments.
For the second quarter of 2014, BAX expects revenues to grow
between 12 and 13%, barring the impact of foreign currency. The
company also expects adjusted earnings in the range of $1.18 to
$1.22 per share for the quarter, compared with the Zacks
Consensus Estimate of $1.20.
Currently, BAX has a Zacks Rank #3 (Hold). Some better-ranked
stocks in the medical products industry include
Edwards Lifesciences Corp.
St. Jude Medical Inc.
). Enzymotec sports a Zacks Rank #1 (Strong Buy), while both
Edwards Lifesciences and St. Jude Medical retain a Zacks Rank #2