FDA Grants Orphan Drug Designation For Halozyme's PEGPH20 - Quick Facts

(RTTNews) - Halozyme Therapeutics, Inc. (HALO) on Friday said it received orphan drug designation for PEGylated Recombinant Human Hyaluronidase or PEGPH20 from the U.S. Food and Drug Administration or FDA. The company is investigating PEGPH20 in a Phase 2 trial in combination with ABRAXANE in metastatic pancreatic cancer.

"This designation follows the Fast Track designation and allows us to collaborate more closely with the FDA to facilitate development of PEGPH20 and is part of our core strategy to bring this therapy to patients as rapidly as possible," said Dr. Helen Torley, CEO of Halozyme. The orphan status is granted to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Also, it will provide a seven-year period of market exclusivity in the U.S., following product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.