Halozyme Therapeutics

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Halozyme Therapeutics
Type	Public (AMEX: HTI)
Founded	1998
Headquarters	San Diego, California, USA
Key people	Jonathan E. Lim, CEO & President
Industry	Biopharmaceutical
Products	Biologics
Revenue	$127,209 USD (2005)
Employees	34
Slogan	'
Website	www.halozyme.com

Halozyme Therapeutics (AMEX: HTI) is an American international pharmaceutical company based in San Diego, California. They are a developmental and commercial stage biopharmaceutical company. They currently have two products on the market which include Hylenex and Cumulase.

1 Divisions
2 History
3 Products
4 Competitors
5 External links

[edit] Divisions

Oncology
Pallative Medicine
Infertility
Drug Delivery

[edit] History

Halozyme Therapeutics started in San Diego, California in 1998. They use strategic partnerships with major healthcare companies including Baxter International.

Their products under development are based on a family of human enzymes known as hyaluronidases. Hyaluronidases are enzymes (proteins) that break down hyaluronic acid, which is a naturally occurring substance in the human body. The technology used by the company is based on recombinant human PH20 (rHuPH20), a human synthetic version of hyaluronidase that degrades hyaluronic acid, a space-filling, gel-like substance that is a major component of tissues throughout the body, such as skin and cartilage. The PH20 enzyme is a naturally occurring enzyme that digests hyaluronic acid to temporarily break down the gel, thereby facilitating the penetration and diffusion of other drugs and fluids that are injected under the skin or in the muscle. It also degrades the cumulus matrix surrounding oocytes (eggs) facilitating in vitro fertilization.

They currently have two FDA-approved products, Cumulase and Hylenex. They also have one product candidate, Chemophase, which is currently in clinical development. All other product candidates are in the research or pre-clinical stage of development. They received a CE (European Conformity) Mark for Cumulase in December 2004 and FDA clearance in April 2005. They launched Cumulase in the European Union and in the United States in June 2005.

During March 2005, they filed a new drug application for the spreading agent Hylenex. Other manufacturers have FDA approved products for use as spreading agents, including ISTA Pharmaceuticals, Inc., with an ovine hyaluronidase, Vitrase®, Amphastar Pharmaceuticals, Inc., with a bovine hyaluronidase, Amphadase, and Primapharm, Inc. also with a bovine hyaluronidase, Hydase. The FDA has determined that Amphadase, Hydase, Hylenex and Vitrase are distinct new chemical entities and hence afforded five years of market exclusivity. During December 2005, they received FDA approval for Hylenex.

During June 2005, they submitted an investigational new drug application in order to begin clinical testing of Chemophase product candidate. They received authorization to initiate clinical testing of Chemophase in August 2005, and they commenced patient enrollment in their initial clinical protocol under in October 2005. In March 2006, they completed enrollment in their Chemophase Phase I clinical trial.