Baxter International Inc. BAX and CTI BioPharma CTIC recently presented clinical data from PERSIST -1 — a study which compares the efficacy and safety of pacritinib with that of the best available therapy (BAT) in patients diagnosed with myelofibrosis. Pacritinib is an investigational oral tyrosine kinase inhibitor having dual activity against JAK2 and FLT3.
Myelofibrosis is a bone marrow disorder that interrupts body’s normal production of blood cells. Notable symptoms of myelofibrosis are severe anemia, weakness, fatigue, and often, an enlarged spleen and liver. The disease occurs when blood stem cells develop a genetic mutation known as JAK2 (Janus kinase 2).
The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in kinases are believed to be the cause of certain blood-related cancer including myeloproliferative neoplasms, leukemia and lymphoma.
Data presented at the American Society of Clinical Oncology (ASCO), currently being held in Chicago over May 29-Jun 2, 2015, showed that compared to BAT (excluding a JAK inhibitor) pacritinib is effective in reducing spleen volume (35% or greater from baseline to Week 24 by MRI/CT scan), thus meeting the primary endpoint of the study.
It also showed that pacritinib is effective in controlling disease-related symptoms (50% or greater from baseline to Week 24 by MRI/CT scan), thus meeting the secondary end-point of the study. Moreover, 25% of anemic patients treated with pacritinib became transfusion independent, compared to zero patients treated with BAT.
In Nov 2013, Baxter and CTI signed a global licensing agreement to jointly develop and commercialize pacritinib. As per the agreement, BAX gained the commercialization rights for all indications for pacritinib outside the U.S. while it jointly commercializes with CTI in the U.S.
In Aug, 2014, FDA granted a Fast track designation to pacritinib, for the treatment of intermediate and high-risk myelofibrosis. Earlier, a second phase 3 trial, known as PERSIST-2, was initiated in Mar 2014 to further investigate the impact pacritinib as compared with BAT including approved JAK2 inhibitors.
Patricinib adds to the growing product pipeline of Baxter’s Bioscience division — which the company will shortly spin-off into a publicly traded company – Baxalta Inc. We believe that recent positive clinical data from the studies of BAX 817 (recombinant factor VIIa (rFVIIa) for hemophilia A or B patients who develop inhibitors to the treatment), BAX 111 (von Willebrand disease (VWD) drug) and Hemophilia A drug BAX 855 also hold promise for the new company.
However, the impending split is expected to remain an overhang for the time being. Further, foreign currency volatility will continue to hurt results in the near term. Intense competition in the hemophilia franchise and lackluster hospital spending are other major concerns.
Stocks to Consider
Currently, Baxter carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include Hospira HSP and Vascular Solutions VASC. Both the stocks sport a Zacks Rank #1 (Strong Buy).
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