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Roche (Basel, Switzerland, www.roche.com) will apply the "Enhanze" technology of Halozyme Therapeutics (San Diego, CA, www.halozyme.com) to its biological therapeutic compounds.
Roche (Basel, Switzerland, www.roche.com) will apply the “Enhanze” technology of Halozyme Therapeutics (San Diego, CA, www.halozyme.com) to its biological therapeutic compounds. The technology can improve the penetration of large-molecule drugs, thus reducing dosing frequency, and allowing biologics drugs to be administered via subcutaneous, rather than intramuscular, injection.
“Enhanze” is Halozyme’s proprietary drug delivery technology based on its recombinant human hyaluronidase (rHuPH20), a recombinant form of the naturally occurring human enzyme that breaks down hyaluronic acid (HA). HA is a space-filling gel-like substance, which is a major component of tissues throughout the body, such as skin and cartilage. By temporarily breaking down HA, rHuPH20 clears channels in tissues to facilitate the penetration and diffusion of therapeutic molecules that are injected subcutaneously, intramuscularly, or intravenously.
When combined or co-formulated with certain injectable drugs, Enhanze technology can allow molecules as large as 200 nanometers to pass freely through the perforated extracellular matrix, which recovers its normal density within approximately 24 hours, thus avoiding any permanent alteration of the skin’s architecture. By improving the penetration of large-molecule drugs, the technology can allow more volumes of drug to be administered at once, thus reducing dosing frequency. The technology can also make it possible for the route of administration to be changed from intramuscular to subcutaneous, facilitating patient self-administration.
“We believe that our technology can enhance the clinical benefits that biologics have already been shown to provide,” says Jonathan Lim, MD, Halozyme’s president and CEO. “The Enhanze technology provides patients with the ability of self-administration at home, better controlled dosing, and potential reduction in infusion reactions,” he says.
This is the first Enhanze technology deal for Halozyme. Under the terms of the agreement, Roche will pay Halozyme $20 million as an upfront payment for the application of rHuPH20 to three pre-defined Roche biologic targets. Over the next ten years, Roche will also have the option to exclusively develop and commercialize rHuPH20 with an additional ten targets. Pending the successful completion of a series of clinical, regulatory, and sales events, Roche may pay Halozyme further milestones which could potentially reach a value of up to $111 million as well as royalties on potential product sales for the first three targets.
Under the collaboration, Roche will also obtain access to Halozyme’s expertise in developing and applying rHuPH20 to Roche targets. Roche will obtain a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche target compounds resulting from the collaboration.