) 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
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
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
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
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,
) look attractive. While Novo Nordisk currently carries a Zacks
Rank #2 (Buy), Salix and Santarus carry Zacks Rank #1 (Strong
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