Baxter International Inc. (BAX) revealed that U.S. Food and Drug Administration (FDA) has approved its HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] subcutaneous treatment meant for adult patients suffering from primary immunodeficiency (PI). The HYQVIA immune globulin (IG) treatment is based on the rHuPH20 platform developed by Halozyme Therapeutics, Inc., (HALO).
HYQVIA is superior to other subcutaneous treatments because it needs delivery of a full therapeutic dose of IG less frequently compared to them. HYQVIA treatment requires only one infusion just once per month (every three to four weeks) and one injection site per infusion to deliver a full therapeutic dose of IG.
The other subcutaneous IG treatments require weekly or bi-weekly treatment with multiple infusion sites per treatment. Currently, PI patients receive intravenous infusions in a physician’s office or infusion center.
Baxter expects to launch HYQVIA in the U.S. in a few weeks. Last year, HYQVIA has been already approved in Europe for adults with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections.
As a result, the HYQVIA treatment is currently prescribed in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
In March this year, Baxter had announced plans to split-up its biopharmaceuticals and medical device segments into two independent companies in order to put greater management focus on the two businesses, effectively commercialize product offerings, efficiently allocate resources to high growth areas, and bring flexibility in deciding on growth and investment strategies.
Baxter’s biopharmaceuticals/bioscience division will focus on immune deficiencies and blood-related disorders and includes the plan to form a partnership or sale of its drug development programs based on the flu and Lyme diseases.
Ludwig N. Hantson – the current president of BioScience division – will be named as the CEO of the new biopharmaceuticals company. Baxter director Wayne T. Hockmeyer will serve as non-executive chairman of the new unit.
BAX’s medical products division manufactures intravenous (IV) solutions and administration sets, premixed drugs and drug-reconstitution systems, pre-filled vials and syringes for injectable drugs, IV nutrition products, infusion pumps, and inhalation anesthetics.
The medical products business contributed $8.7 million or 57% to BAX’s overall revenues in 2013. The business will continue to integrate the $4 billion acquisition of Swedish dialysis maker Gambro AB, completed last September, which complements its existing renal therapies franchise.
BAX’s current CEO and chairman, Robert L. Parkinson Jr., will lead the medical products business in the future, retaining its international name. Baxter expects to complete splitting up the business in mid-2015.
Halozyme Therapeutics is a biopharmaceutical company that develops advanced patient care products. The company mainly focuses on a family of human enzymes, known as hyaluronidases, which increase the absorption and dispersion of biologics, drugs and fluids.
Currently, both Baxter and Halozyme Therapeutics retain a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical products industry include ICU Medical, Inc. (ICUI) and Symmetry Medical, Inc. (SMA). ICU Medical sports a Zacks Rank #1 (Strong Buy), while Symmetry Medical carries a Zacks Rank #2 (Buy).
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