Positive Data on Baxter's Trial for BAX 855

Zacks Equity Research

Baxter International Inc. (BAX) announced positive results from its Phase III clinical trial evaluating the efficacy of BAX 855, which is an extended half-life, recombinant factor VIII (rFVIII) protein used for hemophilia A treatment. The results revealed that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for hemophilia patients.

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 Nektar Therapeutics (NKTR). Notably, the PEGylation technology is designed to extend the duration of protein activity in the body.

The pivotal trial was conducted with the aim to evaluate the effectiveness of BAX 855 in reducing annualized bleed rates (ABR) during the treatment as compared to on-demand treatments. The study also appraised the safety and immunogenicity of the compound when administered on either prophylaxis or on-demand treatment regimens.

The multi-center, open-label trail called PROLONG-ATE evaluated BAX 855 on 138 adolescent and adult patients with previously-treated hemophilia A. The study revealed that patients in a twice-weekly prophylaxis arm experienced a 95% reduction in median ABR as compared to those in the on-demand arm.

Results from the Phase III study were consistent with the findings from the Phase I study which established that the half-life (measuring the duration of activity of the drug in the body) of the investigational compound was approximately 1.5 times higher than ADVATE.

Furthermore, no patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. However, the most common (three patients) product-related adverse event was headache.

Going Forward

BAX expects to submit a Biologics License Application (:BLA) for BAX 855 to the U.S. Food and Drug Administration (:FDA) before the end of 2014 and also plans to present additional data in the coming months.

In addition to an ongoing study on patients who have completed the pivotal trial, BAX will initiate a Phase III, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated severe hemophilia A patients below the age of 12.

Moreover, BAX intends to file a Marketing Authorization Application with the European Medicines Agency (EMA.TO) upon completion of the pediatric study, consistent with the guidelines published by the agency.

Currently, BAX carries a Zacks Rank #3 (Hold). Better-ranked medical product stocks include ICU Medical, Inc. (ICUI) and Abaxis, Inc. (ABAX). ICU Medical sports a Zacks Rank #1 (Strong Buy) while Abaxis carries a Zacks Rank #2 (Buy).

Read the Full Research Report on BAX
Read the Full Research Report on ABAX
Read the Full Research Report on NKTR
Read the Full Research Report on ICUI


Zacks Investment Research