Halozyme Therapeutics, Inc., a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, has announced that the US FDA has accepted for filing and review Halozyme's New Drug Application (NDA) for Hylenex (formerly referred to as Enhanze SC).

Halozyme submitted the Hylenex NDA on March 23, 2005, seeking approval for use as a spreading agent to facilitate the dispersion and absorption of other drugs. FDA has granted the Company in April 2005 Priority Review status to the Hylenex NDA, which sets the target date for initial FDA action within six months from the NDA submission date.

Jonathan Lim, Halozyme's chairman and CEO says, "This is a significant step in the FDA's review of Hylenex for use as a spreading agent. If approved by the FDA, we believe Hylenex could offer physicians an attractive alternative to animal-derived hyaluronidases."

Halozyme's hyaluronidase (rHuPH20) is a highly purified, recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronic acid (HA), the space-filling "gel"-like substance that is a major component of tissues throughout the body.