Halozyme Therapeutics ($HALO), the San Diego-based drug-delivery specialist, might have a winner on its hands. The firm's shares closed nearly 19% higher Tuesday on promising Phase III trial data on a version of Roche's breast cancer drug Herceptin that was injected into the fatty layer of the skin with Halozyme's delivery tech.
The 596-patient study met its primary endpoints and showed that Herceptin delivered with Halozyme's tech had comparable safety and efficacy to the intravenous-infusion version now on the market, Halozyme said in a release. The trial tested the therapy on women with early HER2-positive breast cancer. A big advantage of Halozyme's subcutaneous (SC) version of the cancer drug is that it can be given to patients in about 5 minutes, while IV infusions take a half hour. The new formulation doesn't require medication preparation in pharmacies. The data are expected to be included in an application for approval in the European Union next year, and Halozyme stands to gain milestone payments and royalties on sales from Roche.
The SC version of Herceptin uses Halozyme's delivery tech that boosts absorption and dispersion of biologics. Roche and Halozyme are also applying the technology to a formulation of Roche's cancer drug rituximab and testing it in trials for patients with certain forms of lymphoma and leukemia. The firm's delivery tech involves the use of a recombinant enzyme called rHuPH20, which spurs absorption of biologics. The two companies struck a deal to work on developing drugs with the enzyme in 2006, and companies such as Baxter, ViroPharma and Intrexon have teamed with Halozyme on programs involving the delivery tech as well.
"We are very pleased to see this important program achieve success in a Phase 3 pivotal clinical trial," Gregory Frost, Ph.D., Halozyme's president and CEO, said in the release. "The convenience of subcutaneous administration may provide another option for women living with early breast cancer."
- here's the release
- see the update from RTTNews
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