Positive Trial Results for Baxter's BAX 111 - Analyst Blog

A day before World Hemophilia Day, Baxter International Inc. BAX 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.

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 additional complication.

Going Forward

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 111.

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.

Recent Earnings

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.

Zacks Rank

Currently, BAX has a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical products industry include Enzymotec Ltd. ENZY Edwards Lifesciences Corp. EW, and St. Jude Medical Inc. STJ. Enzymotec sports a Zacks Rank #1 (Strong Buy), while both Edwards Lifesciences and St. Jude Medical retain a Zacks Rank #2 (Buy).