Baxter International Inc. (BAX) 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.
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). 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 include Hill-Rom Holdings, Inc. (HRC), and NuVasive, Inc. (NUVA). Both of them carry a Zacks Rank #1 (Strong Buy).