Roche's (RHHBY) supplemental Biologics License Application (sBLA) for the use of Perjeta before surgery (after diagnosis) in patients suffering from HER2+ early-stage breast cancer was recently accepted by the US Food and Drug Administration (:FDA) for priority review.
The application was primarily based on results from two phase II studies, NEOSPHERE and TRYPHAENA, evaluating Perjeta in treating HER2+ early-stage breast cancer and a phase III study, CLEOPATRA wherein the longer-term safety of Perjeta was evaluated.
With the FDA granting priority review, a final decision is expected by Oct 31, 2013.
Moreover, Perjeta was recently approved by the Japanese Ministry of Health, Labour and Welfare for treating HER2+ inoperable or recurrent breast cancer. The approval was based on positive results from the CLEOPATRA study.
The results from the study showed that the risk of death was reduced by 34% in patients who received the combination of Perjeta, Herceptin and chemotherapy in comparison to patients receiving the combination of Herceptin and chemotherapy.
We remind investors that Roche obtained EU approval for Perjeta in Mar 2013, as a combination therapy for the treatment of adults with previously untreated HER2+ metastatic breast cancer (mBC).
Meanwhile, apart from providing therapeutic products and services for diverse medical needs, Roche continues to focus on innovative diagnostic solutions for the early detection and treatment of diseases.
Roche recently announced that it has acquired Boston-based Constitution Medical Investors, Inc. for $220 million. In addition, Roche will make milestone payments as and when achieved.
Constitution Medical Investors is developing an innovative hematology testing system, which enables faster and more accurate diagnosis of blood-related diseases. The acquisition of Constitution Medical Investors will further strengthen Roche’s diagnostics portfolio.
We are encouraged by Roche’s efforts to strengthen its portfolio through pipeline development and acquisitions.
Roche currently carries a Zacks Rank #4 (Sell). Right now, Novo Nordisk (NVO), Salix Pharmaceuticals (SLXP) and Santarus, Inc. (SNTS) look attractive. While Novo Nordisk currently carries a Zacks Rank #2 (Buy), Salix and Santarus carry Zacks Rank #1 (Strong Buy).
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