drug from an old one. For example, Halozyme is experimenting with adding the enzyme to regular insulin, which is available as a generic, and some fast-acting insulin brands that will soon lose patent protection. The company wants to see if the enzyme will speed the absorption of both types of insulin.
Halozyme was founded in 1998 by a group of scientists led by Gregory I. Frost, who is currently the company’s chief scientific officer. Frost became interested in hyaluronidase as a young researcher at UC San Francisco, where he earned a doctorate in pathology. The company believed there was room for recombinant hyaluronidase, which would lack the foreign proteins and other impurities inherent in enzymes derived from slaughterhouse animals.
Halozyme went public in 2004 through a reverse merger with Global Yacht Services, a struggling company that ran corporate charters out of San Diego. Halozyme’s recombinant hyaluronidase received FDA approval in 2005. Deals followed.
Baxter International markets Halozyme’s hyaluronidase under the name Hylenex as an adjuvant to increase the absorption and dispersion of injectible drugs, such as anesthetics, or fluids. Gustafson said subcutaneous hydration is a useful option in small children, whose little veins make it difficult to start an IV.
In addition, Baxter is using the enzyme to provide injections of plasma-derived immune globulin. The company is sponsoring a late-stage trial in which patients first receive the enzyme followed by an immune globulin shot. Currently, people with AIDS and other immunosuppressive conditions receive immune globulin intravenously. Trial results are expected by the end of this year.
Halozyme’s partnership with Roche with trastuzumab is part of a broader alliance worth up to $612 million, $53 million of which has been received to date. Besides trastuzumab, Roche has initiated clinical tests of two additional reformulated drugs, which haven’t been identified.
To become more than an ingredient company, however, Halozyme needs to develop its own portfolio of drugs. Besides diabetes, where the company is currently conducting multiple early- and mid-stage trials with insulin and fast-acting insulin, Halozyme is targeting cancer.
A gel-like substance protects solid tumors, particularly those found in pancreatic cancer. In animal studies, Halozyme has used hyaluronidase to break down the protective gel coating, causing the tumor to collapse. Now the company is conducting an early-stage study of hyaluronidase in patients with various solid tumor types.
Halozyme expects to see results from some of its diabetes and cancer studies later this year. With two partner studies also nearing completion, 2010 could be a big year for Halozyme. Stay tuned.