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Halozyme Therapeutics, Inc. (BULLETIN BOARD: HZYM), San Diego, a development stage biopharmaceutical company developing and commercializing recombinant human enzymes, reiterates its plans for a first quarter 2005 NDA filing for Enhanze SC(TM). Halozyme believes that the potential approval and market introduction of Enhanze SC will not be impeded by the U.S. Food and Drug Administration's grant of marketing exclusivity to Vitrase(R) (hyaluronidase for injection; lyophilized, ovine).

Enhanze SC is a formulation of recombinant human hyaluronidase manufactured by a biotechnology process that results in a highly purified enzyme preparation. Vitrase, on the other hand, is a formulation of hyaluronidase extracted from ovine (ram) testicles. The company believes that Enhanze SC, recombinant human hyaluronidase, is a New Molecular Entity and is differentiated from both bovine and ovine hyaluronidase products.

Enhanze SC is subject to the U.S. Food and Drug Administration's policy for recombinant DNA products established in 1986, and will be treated as a new product. For these reasons, among other factors, the company believes that it remains on track for its first quarter 2005 NDA filing for Enhanze SC.

Enhanze SC, the first product in Halozyme's Enhanze(TM) Technology portfolio, is being developed as a "spreading agent" to enhance the drug delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (also called hypodermoclysis). Halozyme believes Enhanze SC is the only known recombinant human hyaluronidase under development.

Halozyme's hyaluronidase (rHuPH20) is a 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 Therapeutics, Inc. is a development stage biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility (CUMULASE(TM)), ophthalmology (ENHANZE SC(TM)), and oncology (CHEMOPHASE(TM)) communities. The company's portfolio of products in development is based on intellectual property covering the family of human enzymes known as hyaluronidases. The first recombinant human hyaluronidase (rHuPH20) is being developed by Halozyme as a medical device (CUMULASE(TM)), drug enhancement agent (ENHANZE SC(TM)), and therapeutic biologic (CHEMOPHASE(TM)).

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Publication:Biotech Business
Date:Nov 1, 2004

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