Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the U.S. Food and Drug Administration (FDA) is requesting additional information to complete its review of the HyQ Biologics License Application (BLA).
Baxter and Halozyme will work closely together to develop studies to provide additional data to address concerns raised by the FDA related to the long-term chronic use of HyQ. The companies now expect to participate in a meeting of the FDA’s Blood Products Advisory Committee concerning the agency’s request for additional data. The companies expect these requests to require additional time to complete and to delay the companies’ anticipated regulatory review and approval timeline.
HyQ is an investigational, combination product that includes Immune Globulin (IG) Infusion 10% (Human) and Recombinant Human Hyaluronidase, which are packaged as a kit. IG provides the therapeutic effect of HyQ and the Recombinant Human Hyaluronidase facilitates the dispersion and absorption of the IG. The IG is a 10% solution that is prepared from human plasma and contains a broad spectrum of antibodies.About Baxter International Inc. Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. About Halozyme Therapeutics Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme’s pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex ® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com. This release includes forward-looking statements concerning the companies’ future development plans for HyQ. These forward-looking statements involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words “expect,” "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including actions of regulatory bodies and other governmental authorities, satisfaction of regulatory approval requirements, including with respect to data, competitive conditions, and other risks identified in the companies’ filings with the Securities and Exchange Commission, including reports on Forms 10-K and 10-Q. Neither Baxter nor Halozyme undertake any duty to update their forward-looking statements. Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50238928&lang=en