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Halozyme: Roche Gets EU Marketing Approval For Breast Cancer Drug Herceptin SC

Biopharmaceutical company Halozyme Therapeutics, Inc. (HALO) Monday said that the European Commission has granted Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK) European Union marketing authorization for the use of a time-saving subcutaneous formulation of Herceptin (trastuzumab) for treating HER2-positive breast cancer.

This formulation utilizes Halozyme's recombinant human hyaluronidase (rHuPH20). It is administered in two to five minutes, rather than 30 to 90 minutes with the standard intravenous form.

HER2-positive cancer is a particularly aggressive form of breast cancer. In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 or HER2 are present on the surface of the tumor cells. This is known as "HER2 positivity", which affects about 15% to 20% of women with breast cancer.

The company noted that the European Commission's approval was based on data from the HannaH study that showed that the subcutaneous formulation of Herceptin was associated with comparable efficacy to Herceptin administered intravenously in women with HER2-positive early breast cancer. It resulted in non-inferior trastuzumab plasma levels.

Halozyme added that overall, the safety profile in both arms of the HannaH study was consistent with that expected from standard treatment with Herceptin and chemotherapy in this setting. No new safety signals were identified.

Gregory Frost, CEO of Halozyme, said, ''This approval is great news for the more than 80,000 patients who receive treatment with Herceptin each year in the EU. The reduced administration time and enhanced convenience may enable patients in the EU to spend less time in the hospital while also increasing efficiency for physicians and other health care providers."

It was in December 2006 that Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze technology to Roche's biological therapeutic compounds. Roche has already elected to develop and commercialize products using rHuPH20 with a total of five exclusive targets. Roche also retains the option to apply rHuPH20 to three additional targets through the payment of annual license maintenance fees.

Halozyme noted that Roche will pay it additional milestones as well as royalties on product sales for Herceptin SC, MabThera SC and other product candidates developed and commercialized under the agreement, subject to the successful achievement of clinical, regulatory, and sales events.

In February 2011, Roche began a Phase 3 registration trial of subcutaneous MabThera (rituximab), an anticancer biologic, in patients with non-Hodgkin's lymphoma and chronic lymphocytic leukemia. The company submitted a line extension application to the European Medicines Agency for MabThera SC in December 2012.

Halozyme shares closed Friday's trading at $8.31, up $0.06 or 0.73 percent.

Roche shares settled on Friday at 232.10 Swiss francs, down 2 francs or 0.85 percent.

by RTT Staff Writer

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