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Hylenex

Halozyme Therapeutics, Inc.

Drug Names(s): rHuPH20, Enhanze SC, hyaluronidase human injection

Description: Enhanze SC (rHuPH20) is a recombinant form of the naturally occurring human enzyme, hyaluronidase. Hyaluronidase 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. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity.

Hyaluronidase, 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. Enhance SC 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).

Deal Structure: Halozyme and Baxter
During August 2004, Halozyme and Baxter signed an Exclusive Distribution Agreement for Baxter to market, distribute and sell Hylenex in the United States and Puerto Rico.

During March 2005, Halozyme and Baxter entered into a Development and Supply Agreement and a First Amendment to their existing Distribution Agreement. Under the terms of the agreements, Halozyme will supply Baxter with the active pharmaceutical ingredient, and Baxter will fill and finish Hylenex and hold it for subsequent distribution. The First Amendment modifies various covenants of Baxter relating to the definition of marketing and incremental sales costs, including a cap on the annualized amount of marketing and incremental sales costs to be solely paid by Baxter. In the event that both parties agree in advance to incur combined marketing and incremental sales costs in excess of the cap, such excess marketing and incremental sales costs shall be shared equally. Currently, the...See full deal structure in Biomedtracker


Hylenex News

Pink Sheet Approval In Brief


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