Hylenex
hyaluronidase
Treatment for Adjuvant Agent to Enhance Drug DeliveryHalozyme Therapeutics Announces FDA Acceptance of Hylenex NDA
SAN DIEGO, May 26, 2005 -- Halozyme Therapeutics, Inc. , a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced that the U.S. Food and Drug Administration (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. The Company previously announced in April 2005 that the FDA granted Priority Review status to the Hylenex NDA, which sets the target date for initial FDA action within six months from the NDA submission date.
"We are excited that the FDA has accepted our NDA filing," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "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. Hyaluronidase that is injected in the skin or in the muscle can temporarily digest the HA gel to enhance the penetration and diffusion of other injected drugs or fluids.
About Halozyme Therapeutics, Inc.
Halozyme is a development stage biopharmaceutical company dedicated
to developing and commercializing recombinant human enzymes for the
infertility, ophthalmology, and oncology communities. The company's
portfolio of products under development is based on intellectual
property covering the family of human enzymes known as
hyaluronidases. Halozyme's recombinant human enzymes may replace
current animal slaughterhouse-derived enzymes that carry potential
risks of animal pathogen transmission and immunogenicity. The
versatility of the first enzyme, rHuPH20, enables Halozyme to
develop the product as a medical device, drug enhancement agent,
and therapeutic biologic.
Related Articles:
Hylenex Halozyme Therapeutics/Baxter Healthcare Corporation - Treatment for Adjuvant Agent to Enhance Drug Delivery - December 2, 2005
New Drug Applications Archive
2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
