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The Zacks Analyst Blog Highlights: Bayer, Johnson & Johnson, Novo Nordisk, AbbVie and Astellas Pharma

  The Zacks Analyst Blog Highlights: Bayer, Johnson & Johnson, Novo Nordisk,
                          AbbVie and Astellas Pharma

PR Newswire

CHICAGO, March 28, 2013

CHICAGO, March 28, 2013 /PRNewswire/ -- Zacks.com announces the list of stocks
featured in the Analyst Blog. Every day the Zacks Equity Research analysts
discuss the latest news and events impacting stocks and the financial markets.
Stocks recently featured in the blog include Bayer (OTC:BAYRY), Johnson &
Johnson (NYSE:JNJ), Novo Nordisk (NYSE:NVO), AbbVie Inc.(NYSE:ABBV)
andAstellas Pharma, Inc.(OTC:ALPMY).

(Logo: http://photos.prnewswire.com/prnh/20101027/ZIRLOGO)

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Here are highlights from Wednesday's Analyst Blog:

Japanese Approval for Bayer Drug

Bayer's (OTC:BAYRY) HealthCare segment recently received encouraging news as
the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Stivarga
(regorafenib). Stivarga is approved in Japan for the treatment of patients
suffering from unresectable, advanced/recurrent colorectal cancer (CRC).

Bayer stated in its press release that CRC is the third most common cause of
cancer death in Japan. More than 40,000 people die in Japan every year due to
CRC.

The Japanese approval of Stivarga was based on results from the phase III
CORRECT study. Results from the study showed improvement in overall survival
and progression-free survival in comparison to placebo, in patients suffering
from metastatic CRC (mCRC) and whose disease had progressed after approved
standard therapies.

Stivarga is already approved in the US for treating patients suffering from
mCRC, whose disease had progressed even after treatment with standard drugs
prescribed for the disease. Stivarga is also approved for metastatic
gastrointestinal stromal tumors (GIST) indication in the US. Bayer is also
seeking EU approval of Stivarga for the treatment of mCRC.

Bayer, meanwhile, received a huge setback earlier this month when the company
and its partnerJohnson & Johnson (NYSE:JNJ) received a second complete
response letter (CRL) from the US Food and Drug Administration (FDA) for their
supplemental New Drug Application (sNDA) for Xarelto (2.5 mg twice daily) for
the reduction of the risk of secondary cardiovascular events in patients
suffering from ACS.

The second CRL for Xarelto is a big disappointment for the company. Bayer, a
large cap pharma company, currently carries a Zacks Rank #4 (Sell). Meanwhile,
other large cap pharma stocks such asNovo Nordisk(NYSE:NVO) andAbbVie
Inc.(NYSE:ABBV) are better positioned carrying a Zacks Rank #2 (Buy).

Astellas' Acofide Approved in Japan

Astellas Pharma, Inc.(OTC:ALPMY) and Zeria Pharmaceutical Co., Ltd. recently
announced that it received approval from Japan's Ministry of Health, Labour
and Welfare (MHLW) for Acofide for the treatment of functional dyspepsia (FD).

The regulatory application was based on a multicenter, randomized,
double-blind, parallel-group and placebo-controlled phase III clinical study.
The results showed statistically significant data when compared to placebo, in
both the primary endpoints and several secondary endpoints.

In Mar 2008, Astellas and Zeria had entered into an agreement for the
co-development and co-marketing of Acofide. Zeria had submitted the
application for marketing approval to the MHLW in Japan in Sep 2010.

Acofide is the first approved product to have shown efficacy for the treatment
of FD under the Rome III diagnostic criteria. Rome III is the latest version
of the international classification and diagnostic criteria for functional
gastrointestinal disorders.

Meanwhile, Astellas is also looking to get its type II diabetes candidate,
ipragliflozin (ASP1941), approved in Japan. Earlier this month, Astellas had
announced the submission of a marketing authorization application (MAA) for
its sodium-glucose co-transporter 2 (SGLT2) inhibitor, ipragliflozin
(ASP1941), to the MHLW in Japan. The application was based on a phase III
pivotal study on ipragliflozin as monotherapy for the treatment of type II
diabetes. The study showed a significant reduction in HbA1c levels. Astellas
conducted six phase III studies to investigate the long-term safety and
efficacy of ipragliflozin in combination with other hypoglycemic agents.
Results showed effectiveness and a favorable safety profile.

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