Halozyme, Ventana To Develop Companion Diagnostic Assay For Use With PEGPH20

(RTTNews) - Halozyme Therapeutics Inc. (HALO) and Ventana Medical Systems Inc. (VMSI), a member of the Roche Group, announced a global agreement to collaborate on the development of, and for Ventana to ultimately commercialize, a companion diagnostic assay for use with Halozyme's investigational new drug, PEGPH20.

PEGPH20 is an investigational PEGylated form of Halozyme's recombinant human hyaluronidase under clinical development for the systemic treatment of tumors that accumulate hyaluronan. The FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. The European Commission designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.

Under the agreement, Ventana will develop an in vitro diagnostic, under design control, using Halozyme's HA binding protein, with the intent of submitting it for regulatory approval in the United States, Europe and other countries.