8/1/2012 2:54:56 PM
SAN DIEGO, Aug. 1, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Baxter's HyQ Biologics License Application (BLA). HyQ is an investigational product that includes plasma-derived Immune Globulin (IG) 10% and Halozyme's recombinant human hyaluronidase (rHuPH20) for subcutaneous administration in patients with primary immunodeficiency disease.
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The letter requested additional preclinical data to support the BLA. The primary issues raised in the letter focused on non-neutralizing antibodies generated against recombinant human hyaluronidase and the possible effects of these antibodies on reproduction, development and fertility. Elevated anti-rHuPH20 antibody titers were detected in the registration trial, but have not been associated with any adverse events.
Pending the parties providing additional preclinical data sufficient to address the regulatory questions, CBER has requested that patients should no longer be dosed with rHuPH20 in the Baxter and ViroPharma clinical studies.
Halozyme has been in contact with the Center for Drug Evaluation and Research (CDER) regarding the impact on Hylenex® recombinant (hyaluronidase human injection). CDER is the division of FDA regulating the other investigational rHuPH20 programs, including insulin and PEGPH20. After reviewing the data, CDER has confirmed that there is no need for actions against Hylenex or clinical programs in the Hylenex IND.
"With receipt of the CRL, we can directly address the questions raised by CBER," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. "We look forward to collaborating with the agency to address their concerns."
Conference Call, August 1, 2012
The Company will host a conference call today, August 1, 2012, at 1:30 pm PT/4:30 pm ET to discuss this development. Gregory I. Frost, President and Chief Executive Officer, will lead the call.
The call will be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast, please log on to www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (877) 407-8037 (domestic callers) or (201) 689-8037 (international callers). A telephone replay will be available shortly after the call by dialing (877) 660-6853 (domestic callers) or (201) 612-7415 (international callers) using account number 367 and replay ID number 398405.
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.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning our products in development, potential benefits and attributes, anticipated clinical and regulatory events and our intended actions) that 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 "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 clinical trial enrollment and results, regulatory requirements, adverse effects associated with the use of our products, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on May 7, 2012.
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