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HyQ

Generic name: immune globulin and recombinant human hyaluronidase
Treatment for: Primary Immunodeficiency Syndrome

Halozyme Confirms Baxter Has Received A Complete Response Letter For HyQ BLA

SAN DIEGO, Aug. 1, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. 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.

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."

About Halozyme

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.

Media/Investor Contacts:

Halozyme (US)
Anne Erickson
Executive Director
Halozyme Therapeutics
858-704-8264
aerickson@halozyme.com

Halozyme (EU) - Media
Danielle Whitney
WCG
+44 (0)7827 860 310
dwhitney@wcgworld.com


SOURCE Halozyme

Posted: August 2012

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