Janssen doses first patient in daratumumab clinical trial using Halozyme's ENHANZE technology

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.