Halozyme Receives FDA Approval For Additional Manufacturing Facilities For Hylenex® Recombinant

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10/20/2014

Expands rHuPH20 Production

SAN DIEGO, Oct. 20, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has approved new contract manufacturing facilities used in the production of Hylenex® recombinant (hyaluronidase human injection). The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon® facility in Greenville, North Carolina, for production of finished Hylenex product.

"The approval of new production sites enables us to substantially increase our manufacturing capacity for Hylenex recombinant," stated Dr. Helen Torley, President and Chief Executive Officer. "Furthermore, the approvals demonstrate our capabilities in the manufacturing and operations area to ensure continuous supply of active ingredients and finished commercial drug products which are essential for our core strategy to commercialize our own proprietary products as well as partner our rHuPH20 technology with innovative companies."

About Hylenex® recombinant (hyaluronidase human injection)

Hylenex® recombinant is a tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs, to facilitate subcutaneous fluid administration and in subcutaneous urography. Hylenex recombinant is contraindicated in patients with a known hypersensitivity to recombinant human hyaluronidase or any excipient used to make the drug. 

The most frequently reported adverse reactions with Hylenex recombinant have been local injection site reactions, such as erythema and pain. For additional information or full Prescribing Information visit www.hylenex.com or www.halozyme.com.

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, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.

About Cook Pharmica LLC

Cook Pharmica is an integrated contract development and manufacturing organization (CDMO) that provides pharmaceutical and biopharmaceutical companies with a unique one-source, one-location model for process development, mammalian cell culture manufacturing, parenteral manufacturing in vials and prefilled syringes, and secondary packaging. The company maintains a simple goal: to deliver quality products in a timely manner. To do this effectively, Cook Pharmica has invested heavily in its facility, people and processes.  Founded in 2004, Cook Pharmica, the biopharmaceutical manufacturing division of Cook Medical, is a privately held, wholly owned subsidiary of parent company Cook Group. For more information, visit www.cookpharmica.com.

About Patheon

Patheon is a leading provider of contract development and commercial manufacturing (CDMO) services to the global pharmaceutical industry for a full array of solid and sterile dosage forms, including large and small molecule API. Patheon, a business unit of DPx Holdings B.V., encompasses the combined commercial manufacturing capabilities and pharmaceutical product development services, as well as offers a full array of biologic services and pharmaceutical active pharmaceutical ingredients (API) development. For more information, visit www.patheon.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning our intention to commercialize our own products and enter into new collaborations with other companies with our rHuPH20 technology) 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 typically, but not always, 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 our ability to enter into new collaborations, delays in completion of clinical trials and other development activities, the possibility of safety events, unexpected expenditures and costs, unexpected results or delays in regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 11, 2014.

Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com

Media Contact:
Susan Neath Francis
212-301-7182
sfrancis@wcgworld.com

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