Halozyme Announces First Clinical Dosing Of Janssen's Daratumumab Using ENHANZE™ Technology

First Patient Dosed in a Clinical Trial for the Subcutaneous Administration of Daratumumab

Nov 04, 2015, 08:30 ET from Halozyme Therapeutics, Inc.

SAN DIEGO, Nov. 4, 2015 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. has dosed the first patient in a clinical trial evaluating subcutaneous (SC) delivery of daratumumab with Halozyme's proprietary ENHANZE™ technology in multiple myeloma.

Daratumumab is an investigational human monoclonal antibody that targets CD38 on the surface of multiple myeloma cells and is in clinical development by Janssen using the intravenous route of administration. Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. Multiple myeloma is the third most common blood cancer in the United States (U.S.), following only leukemia and lymphoma. In the U.S., approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in 2015. Globally, it is estimated that 114,251 people will be diagnosed and 80,019 will die from the disease.

The Janssen Phase 1b clinical trial will evaluate the safety, pharmacokinetics and antitumor activity of a daratumumab by the subcutaneous route of administration in approximately 128 patients with relapsed or refractory multiple myeloma.

"We believe the transition from an IV to subcutaneous formulation has the potential to provide benefits to patients and health care professionals, including reduced administration time," said Dr. Helen Torley, president and CEO of Halozyme. "We are pleased to partner with Janssen to bring these potential benefits to multiple myeloma patients through the development of daratumumab using our proprietary rHuPH20 platform."

Halozyme's ENHANZE technology is based on a proprietary recombinant human enzyme rHuPH20 that targets hyaluronan, a glycosaminoglycan, which is a chain of natural sugars found throughout the body and as a component of the extracellular matrix, to aid in the dispersion and absorption of other injected therapeutic drugs. 

Halozyme Collaboration with Janssen Biotech, Inc.

In December 2014, Halozyme and Janssen entered into a collaboration and license agreement.  Under the terms of the agreement, Halozyme has granted to Janssen a worldwide license to develop and commercialize products for up to five targets, combining rHuPH20 with Janssen's proprietary compounds. CD38, which is targeted by daratumumab, is the first of these five targets. Halozyme received an initial payment of $15 million, and is eligible to receive additional payments upon Janssen's achievement of specified development, regulatory and sales-based milestones, totaling up to $566 million.  Halozyme is also entitled to royalty payments based on net sales of products using the ENHANZE™ technology. Under the collaboration, Janssen will also obtain access to Halozyme's expertise in developing and applying rHuPH20 to Janssen targets and will obtain a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Janssen target compounds resulting from the collaboration.

About ENHANZE™

ENHANZE™ is Halozyme's proprietary drug delivery platform based on the Company's patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections.

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. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung 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 and AbbVie for its drug delivery platform, ENHANZE™, which enables biologics and small molecule compounds that are currently administered intravenously to be delivered subcutaneously. 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 10, 2015.

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

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SOURCE Halozyme Therapeutics, Inc.



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