Roche Holdings Ltd. (RHHBY) reported positive data from a late-stage study (HannaH) on Herceptin (trastuzumab). According to the study, the new subcutaneous (SC) formulation of Herceptin showed comparable efficacy with the standard intravenous (IV) infusion of Herceptin in women suffering from HER2-positive early breast cancer.
While the subcutaneous formulation can be administered in five minutes, the intravenous version takes around half an hour to infuse. Also, since no medicine preparation time is required, the new subcutaneous formulation may significantly reduce pharmacy time.
The HannaH study, which enrolled 596 women with HER2 positive early breast cancer, was conducted to compare the safety and effectiveness of the subcutaneous formulation of Herceptin to the intravenous formulation.
We note that in July 2011, Roche had reported another set of positive data from a late-stage study of a combination treatment involving pertuzumab and Herceptin. The CLEOPATRA study, which was conducted on patients with HER2-positive metastatic breast cancer, demonstrated that patients dosed with the combination of pertuzumab and Herceptin along with docetaxel, experienced longer progression-free survival (primary endpoint) compared to those who received only Herceptin and docetaxel.
Moreover, in December 2010, Roche had reported positive data from a mid-stage study (NEOSPHERE) on Herceptin when given in combination with pertuzumab and docetaxel in women suffering from early-stage, HER2-positive breast cancer. The study demonstrated that treatment with the combination therapy increased the rate of complete tumor disappearance (45.8%) in the breast, as compared to patients treated with Herceptin plus docetaxel (29.0%).
Herceptin, which is currently approved for HER2-positive breast cancer and advanced HER2-positive stomach cancer, posted sales of 3.9 billion Swiss francs for the nine months ended September 30, 2011.
Herceptin faces intense competition from GlaxoSmithKline’s (GSK) Tykerb.
In the short run, we have a Zacks #3 Rank (Hold rating) on Roche.
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