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FDA Accepts Genentech (RHHBY)'s Biologics License Application For Subcutaneous Formulation Of Rituximab



11/3/2016 6:47:41 AM

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SAN DIEGO, Nov. 3, 2016 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has accepted Genentech's Biologics License Application for a subcutaneous formulation of rituximab in multiple blood cancer indications. This is a co-formulation with Halozyme's proprietary recombinant human hyaluronidase enzyme (ENHANZE platform), approved and marketed under the MabThera® SC brand in countries outside the U.S.

"We are excited to see Genentech and Roche taking steps to bring a subcutaneous formulation of rituximab to patients in the United States," said Dr. Helen Torley, president and chief executive officer. "If approved, this formulation has the potential to reduce administration time for patients and health care practitioners."  

Including all approved indications, Roche reported total 2015 sales of rituximab in the United States of 3.76 billion CHF.

About Halozyme
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE drug delivery platform. Halozyme is headquartered in San Diego. For more information visit 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 the possible activity, benefits and attributes of ENHANZE, the possible method of action of ENHANZE, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved, and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery 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 unexpected expenditures and costs, unexpected results or delays in development of product candidates and 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 the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2016.

Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com

Chris Burton
858-704-8352
ir@halozyme.com

Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

Logo - http://photos.prnewswire.com/prnh/20100302/LA63139LOGO

 

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-accepts-genentechs-biologics-license-application-for-subcutaneous-formulation-of-rituximab-300356307.html

SOURCE Halozyme Therapeutics, Inc.


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