Baxter International (BAX) recently revealed that it has filed a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) for acceptance of BAX 326. This is a recombinant factor IX (rFIX) protein which is being evaluated as a treatment option for bleeding incidents in individuals (over 12 years) with hemophilia B.
It is believed that there are 25,000 cases worldwide, including 4,000 in the U.S., with hemophilia B.2. Hemophilia B, the second most common variant of the disorder, is an outcome of a relative lack of clotting factor IX (a normal protein in the blood that checks bleeding).
The filing of this BLA follows the results from a Phase III study carried out in 10 nations. The study measured parameters such as safety and efficacy of BAX 326 on 73 individuals with severe to fairly severe hemophilia B (and who have had prior access to other factor IX treatment). Baxter intends to table the composite data from the study in late 2012. It plans to seek regulatory approval for BAX 326 in EU in 2013.
Baxter provides in certain nations, a plasma-based factor IX therapy, Immunine [Factor IX Concentrate (Human)], for victims of hemophilia B. Further, the company recently announced an agreement with Chatham Therapeutics to bring to market a gene therapy oriented treatment for hemophilia B.
In November 2011, Baxter completed its acquisition of Baxa Corporation. The takeover highlights the company’s continued commitment toward patient safety and nutrition. It also permits Baxter to provide a wider set of solutions for the safe preparation and delivery of IV medication. Baxa’s know-how will benefit patients across the globe.
Moreover, Baxter struck a deal in December 2011 to buy Synovis Life Technologies, a well-known provider of mechanical and biological products for the repair of soft tissue in a large number of surgical operations.
The acquisition will further expand Baxter’s offerings in the area of biosurgery and regenerative treatment. The takeover of Synovis was completed in the first quarter of 2012.
Despite resilience in Plasma Proteins and Antibody Therapy sub-segments, we are concerned about a slightly somber outlook for hospital spending and tightening of reimbursement. We also account for the unfavorable impact of foreign exchange translation and possible dilution associated with the company’s acquisitions of Baxa and Synovis.
Improved execution has lifted sentiment somewhat toward Baxter. It is a good bet for value investors willing to wait as fundamentals improve further. Among others, the company competes with Becton, Dickinson and Company (BDX) in certain niches. The stock currently retains a Zacks #3 Rank, which translates into a short-term Hold recommendation.
BAXTER INTL (BAX): Free Stock Analysis Report
BECTON DICKINSO (BDX): Free Stock Analysis Report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment