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Positive Results on Roche Candidate

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Roche Holdings Ltd. (RHHBY) recently announced results from its phase III study (EMILIA study) of trastuzumab emtansine (T-DM1). The study showed that trastuzumab emtansine significantly improved overall survival (:OS) in people suffering from HER2-positive metastatic breast cancer (mBC) in comparison to the combination of GlaxoSmithKline’s (GSK) lapatinib and Xeloda (capecitabine).

The EMILIA study is evaluating trastuzumab emtansine in patients suffering from HER2-positive mBC and who previously had Herceptina (for the treatment of HER2-positive breast cancer) along with taxane chemotherapy. The study has now met both the co-primary endpoints of improvement in OS and progression-free survival (PFS). Roche now plans to offer patients in the lapatinib and Xeloda arm of EMILIA, the option to receive trastuzumab emtansine.

Notably, in June this year, Roche had announced that the EMILIA study met its first co-primary endpoint of PFS. The study revealed that patients receiving trastuzumab emtansine showed 35% lower risk in disease worsening or death than those who received lapatinib and Xeloda.

Under an agreement with ImmunoGen Inc. (IMGN), Genentech, a member of the Roche Group, licenses technology for trastuzumab emtansine. Genentech submitted a Biologics License Application (:BLA) for the candidate to the US Food and Drug Administration (:FDA). Roche also plans to submit a marketing authorization application for trastuzumab emtansine to the European Medicines Agency (:EMA) soon.

We remind investors that Roche had earlier submitted a BLA seeking accelerated approval for the candidate in July 2010 on the basis of mid-stage trial results. The data demonstrated that the candidate reduced the size of tumors in one-third of patients with advanced HER2-positive breast cancer.

However, in August 2010, the FDA had refused the application because it believed that the patients in the phase II study had not tried all possible medications available for the treatment of mBC. Roche had then decided to continue with its EMILIA study to support the re-submission of the BLA.

We currently have a Zacks #4 Rank (short-term Sell rating) on Roche.

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