Phase 3 Study Of Subcutanous Daratumumab Initiated Using Halozyme's ENHANZE Technology

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10/31/2017

-- Subcutaneous injection has potential to reduce multi-hour infusion to 5-minutes--
-- $15 million milestone payment to Halozyme after enrollment of three patients--

SAN DIEGO, Oct. 31, 2017 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Janssen Biotech, Inc. has initiated the first of three planned Phase 3 clinical trials evaluating a subcutaneous (SC) delivery of Darzalex® (daratumumab) with Halozyme's proprietary ENHANZE® technology.

The initial Phase 3 study is in amyloidosis patients, with additional Phase 3 studies in multiple myeloma and smoldering myeloma patients planned for near-term initiation.

The subcutaneous formulation of daratumumab has an estimated administration time of approximately 5 minutes compared to the multi-hour intravenous infusion, potentially offering new benefits to patients, caregivers and health systems. Halozyme's ENHANZE technology enables the administration of medications with an injection under the skin rather than an infusion into a vein.

"Our goal has been to make the injection of life saving medicines less disruptive to patients using Halozyme's ENHANZE technology," said Dr. Helen Torley, president and CEO of Halozyme. "These studies aim to demonstrate the transformative potential of ENHANZE when combined with Darzalex."

The Phase 3 study follows a Phase 1b clinical trial that demonstrated the safety, pharmacokinetics and anti-tumor activity of the subcutaneous formulation in relapsed or refractory multiple myeloma patients.

Halozyme will receive a $15 million milestone payment from Janssen following dosing of the third patient in a Phase 3 trial.

Darzalex is a human monoclonal antibody that targets CD38 on the surface of cells and is in clinical development by Janssen in a range of cancers and immune diseases.

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 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 is eligible to receive payments upon Janssen's achievement of specified development, regulatory and sales-based milestones, totaling up to $113 million per target. Halozyme is also entitled to royalty payments based on net sales of products using the ENHANZE technology.

About ENHANZE® Technology
Halozyme's proprietary ENHANZE® drug-delivery technology is based on its 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. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

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, Lilly and Bristol-Myers Squibb for its ENHANZE® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit 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 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 Halozyme's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

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.)

 

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SOURCE Halozyme Therapeutics, Inc.

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