Roche Prepares to Make Devices for Drug Using Halozyme Therapeutics Technology

1/21/10

San Diego-based Halozyme Therapeutics (NASDAQ: HALO) received some good news today. Its partner Roche announced plans to invest $182 million in two European factories that will produce a device designed to deliver a drug formulated with Halozyme’s enzyme technology.

The Roche drug is trastuzumab (Herceptin), which is used to treat women with an aggressive form of breast cancer that overproduces a protein called HER2. The drug, which had 2009 sales of about $4.8 billion, is currently administered by infusion in a hospital.

Halozyme’s technology would allow trastuzumab to be administered by subcutaneous injection. This means patients could receive the drug in a doctor’s office or even self-administer the anti-cancer drug at home. Roche says it takes five minutes to administer an injection compared to 60 minutes for an infusion.

The reformulated trastuzumab contains Halozyme’s recombinant PH20 (Enhanze), an enzyme that temporarily breaks down hyaluronic acid, a gel-like substance found in skin and cartilage. The companies believe PH20′s ability to clear out the space-filling gel will enhance the penetration and diffusion of trastuzumab.

Roche (OTCQX: RHHBY), which is based in Basel, Switzerland, says in its announcement today that its factories would produce what it described as “patient-friendly” devices to supply clinical studies and commercialization.

A late-stage clinical study that compares injections with the experimental formulation to infusions of the original drug in 552 breast cancer patients is underway. Patients in the trial are receiving medication every three weeks for one year and will be tracked for two years after the study ends. Roche has said it expects to file for approval to sell injectible trastuzumab in the EU in 2012.

In its press release, Roche said that injectible trastuzumab would simplify patients’ lives and enable more efficient use of hospital resources. If the trial succeeds, Halyzyme’s PH20 could have a substantial impact on the treatment of cancer-and who gets paid to provide the treatment.

Denise Gellene is a former Los Angeles Times science writer and regular contributor to Xconomy. You can reach her at dgellene@xconomy.com Follow @

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