SAN DIEGO, Dec. 19, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA), has designated PEGylated recombinant human hyaluronidase (PEGPH20) an orphan medicinal product for the treatment of pancreatic cancer. Halozyme is currently conducting a Phase 2 study on the treatment of metastatic pancreatic cancer with PEGPH20 in combination with gemcitabine and nab-paclitaxel (ABRAXANE(®)). In October 2014, the Company disclosed that the U.S. Food and Drug Administration also granted Orphan Drug designation for PEGPH20 for the treatment of pancreatic cancer.

"We are very pleased that PEGPH20 has received orphan drug status in the EU," stated Dr. Helen Torley, President and Chief Executive Officer. "This designation is an important regulatory milestone for Halozyme and aligns with our commitment to deliver innovative therapies that transform the lives of cancer patients around the world."

The EMA Orphan Designation is a status assigned to a medicine intended for use against a rare condition (prevalence of the condition in the European Union must not be more than 5 in 10,000) and allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a disease that is life-threatening or a chronically debilitating rare disease. In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to centralized marketing authorization.

About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan.

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, Janssen 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.

Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning future actions relating to the development of PEGPH20 and the possibility that PEGPH20 may be used to address pancreatic cancer) 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 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 November 10, 2014.

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

Media Contact:
Susan Neath Francis
212-301-7182
sfrancis@w2ogroup.com

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SOURCE Halozyme Therapeutics, Inc.