Global medical products and services company, Baxter International Inc. (BAX), has received an approval from the U.S. Food and Drug Administration (FDA) for its PHOXILLUM Renal Replacement Solutions. Cleared for use in continuous renal replacement therapy (CRRT), PHOXILLUM has been granted an orphan drug status by the FDA.
With the approval of PHOXILLUM, Baxter intends to offer healthcare providers additional options in managing critically ill acute kidney injury patients treated with CRRT. The FDA-approved drug can serve as a replacement solution in CRRT to correct electrolyte and acid-base imbalances, and also in cases of drug poisoning when CRRT is used to remove dialyzable substances.
We note that PHOXILLUM is the only FDA-approved premixed solution containing phosphate. Hypophosphatemia (low blood phosphate) is a common electrolyte problem in patients treated with CRRT, which can be managed with the use of PHOXILLUM.
The Deerfield, IL-based company expects the PHOXILLUM phosphate-containing solutions to be available in the U.S. from the second quarter of 2015.
Baxter has an impressive product pipeline with improved existing products and new product development such as more convenient kidney dialysis solutions, regenerative tissue products and products for Hemophilia A treatment. Moreover, the company continues to expand its product portfolio by winning approvals for new drugs and products.
Notably, Baxter’s OBIZUR drug was approved by the FDA in Oct 2014 for treating bleeding episodes in adults with acquired Hemophilia A. In Sep 2014, Baxter won two FDA approvals for HYQVIA and RIXUBIS. While HYQVIA is a subcutaneous treatment for adult patients with primary immunodeficiency, RIXUBIS is used for routine prophylactic treatment, along with control and prevention of bleeding episodes in children with Hemophilia B.
Additionally, Baxter has filed a biologics license application (BLA) with the FDA for the approval of BAX 111 – an investigational drug for the treatment of patients with von Willebrand disease (VWD). If approved, BAX 111 will be the first recombinant treatment in clinical development for VWD, the most common type of inherited bleeding disorder.
Though Baxter has a promising product pipeline, we believe that intense competition in the hemophilia space and lackluster hospital spending will remain an overhang on the stock. Additionally, lower reimbursements for medical products and services could result in pricing pressure and decreased demand for the company’s products.
Currently, Baxter carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the medical products industry include ICU Medical (ICUI), Vascular Solutions (VASC) and ZELTIQ Aesthetics, Inc. (ZLTQ). While both ICU Medical and Vascular Solutions sport a Zacks Rank #1 (Strong Buy), ZELTIQ Aesthetics carries a Zacks Rank #2 (Buy).
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