BLA Submitted to FDA for Subcutaneous Formulation of DARZALEX® Utilizing ENHANZE®

Halozyme Therapeutics announced that its collaborator Janssen Biotech has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma.

"Janssen's BLA submission for subcutaneous DARZALEX® represents an important development for our ENHANZE® drug delivery technology business," said Dr. Helen Torley, president and chief executive officer. "We are delighted that an approval of the subcutaneous formulation may soon provide patients with multiple myeloma a new therapeutic option that offers the potential of DARZALEX® with a shorter administration time."

Janssen's BLA submission follows the announcement of positive results from its Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX® in comparison to intravenous DARZALEX® in patients with relapsed and refractory multiple myeloma. Subcutaneous DARZALEX®, using ENHANZE® drug delivery technology, was found to be non-inferior to intravenous DARZALEX® with regard to the co-primary endpoints of overall response rate and Maximum Ctrough concentration on day 1 of the third treatment cycle.

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.

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