Clinical Trial Results, Litigation Outcomes and Marketing Authorizations - Research Report on Pfizer, GlaxoSmithKline, Sanofi,

  Clinical Trial Results, Litigation Outcomes and Marketing Authorizations -
     Research Report on Pfizer, GlaxoSmithKline, Sanofi, AstraZeneca, and
                                  Neurocrine

PR Newswire

NEW YORK, September 19, 2013

NEW YORK, September 19, 2013 /PRNewswire/ --

Editor Note: For more information about this release, please scroll to bottom.

Today, Investors' Reports announced new research reports highlighting Pfizer
Inc. (NYSE: PFE), GlaxoSmithKline plc (NYSE: GSK), Sanofi SA (NYSE: SNY),
AstraZeneca PLC (NYSE: AZN), and Neurocrine Biosciences, Inc. (NASDAQ: NBIX).
Today's readers may access these reports free of charge - including full price
targets, industry analysis and analyst ratings - via the links below.

Pfizer Inc. Research Report

On September 12, 2013, ViiV Healthcare, a joint company by Pfizer Inc.
(Pfizer) and GlaxoSmithKline plc (GlaxoSmithKline), announced initial results
from the Phase IIIb/IV FLAMINGO (ING114915) study. The Company noted that the
open-label study compared once-daily regimens containing 50mg dolutegravir
with once-daily regimens containing a protease inhibitor (PI) (800mg darunavir
boosted with 100mg ritonavir) in treatment-naive adults with HIV-1. At the
48-week time point between the dolutegravir and darunavir-based regimens, the
initial results demonstrated non-inferiority. "This is the first study in our
clinical programme to compare dolutegravir to a boosted protease inhibitor in
treatment-naive patients. PIs are often selected as part of a first-line
regimen for treatment-naive patients, so these data provide important
information regarding dolutegravir as a treatment choice for these patients,"
said Dr. John Pottage, Chief Medical Officer of ViiV Healthcare. The Full
Research Report on Pfizer Inc. - including full detailed breakdown, analyst
ratings and price targets - is available to download free of charge at:
[http://www.investorsreports.com/report/2013-09-17/PFE]

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GlaxoSmithKline plc Research Report

On September 16, 2013, GlaxoSmithKline plc (GlaxoSmithKline) announced that
the US FDA has granted Priority Review designation to the Company's
supplemental New Drug Applications (sNDAs) for combined use of Tafinlar
(dabrafenib) and Mekinist (trametinib) for the treatment of adult patients
with unresectable or metastatic melanoma with a BRAF V600 E and V600 K
mutation. GlaxoSmithKline informed that the FDA has assigned a Prescription
Drug User Fee Act (PDUFA) target date of January 8, 2014 for the Mekinist
supplement, and January 9, 2014 for the Tafinlar supplement. The Full Research
Report on GlaxoSmithKline plc - including full detailed breakdown, analyst
ratings and price targets - is available to download free of charge at:
[http://www.investorsreports.com/report/2013-09-17/GSK]

--

Sanofi SA Research Report

On September 17, 2013, Sanofi SA (Sanofi) and its subsidiary Genzyme announced
that the European Commission has granted marketing authorization for Lemtrada.
Genzyme informed that it plans to begin launching Lemtrada and the previously
approved Aubagio in the EU soon. "The approvals of Lemtrada and Aubagio in the
European Union represent an important milestone for Genzyme and demonstrate
our focus on scientific innovation and commitment to multiple sclerosis
patients. This is particularly exciting as the EU approval is the first for
Lemtrada globally," said David Meeker, M.D., President and CEO of Genzyme.
"The Lemtrada clinical trial data support its potential to meaningfully
address disability in active RRMS patients, while Aubagio's efficacy, safety
and convenient dosing may provide an important alternative to injectable
therapies. The approvals of Lemtrada and Aubagio represent a significant step
forward in the way we think about treating this disease," added Hans-Peter
Hartung M.D., Ph.D., Professor and Chairman of the Department of Neurology at
Heinrich-Heine-University in Duesseldorf, Germany. The Full Research Report on
Sanofi SA - including full detailed breakdown, analyst ratings and price
targets - is available to download free of charge at:
[http://www.investorsreports.com/report/2013-09-17/SNY]

--

AstraZeneca PLC Research Report

On September 13, 2013, AstraZeneca PLC (AstraZeneca) announced that the US
Court of Appeals for the Federal Circuit (Federal Circuit) has issued a
temporary injunction against the US launch of the 505(b)2 NDA Esomeprazole
Strontium product of Hanmi Pharmaceutical (Hanmi). Previously, in June 2013,
AstraZeneca had entered into an agreement with Hanmi and Amneal
Pharmaceuticals (Amneal) to streamline litigation issues on the proposed
Esomeprazole Strontium and, in July 2013, AstraZeneca had filed a Notice of
Appeal for the Federal Circuit, with the Company seeking a reversal of claim
construction. According to the release, Hanmi received US FDA approval for
Esomeprazole Strontium on August 6, 2013. The Full Research Report on
AstraZeneca PLC - including full detailed breakdown, analyst ratings and price
targets - is available to download free of charge at:
[http://www.investorsreports.com/report/2013-09-17/AZN]

--

Neurocrine Biosciences, Inc. Research Report

On September 9, 2013, Neurocrine Biosciences, Inc. (Neurocrine) announced
Phase IIb results for the 50mg dose of NBI-98854, a small molecule VMAT2
inhibitor in development for tardive dyskinesia. According to the results, the
50 mg dose in Phase IIb Kinect study did not meet the primary endpoint, while
the 100mg dose showed a statistical and clinically significant improvement.
"Although this was not the result we anticipated in the 50mg dose based on the
data set from the earlier clinical studies, we were pleased to see a clear
dose related response at the end of Week 2, with the 100mg dose," said Kevin
C. Gorman, President and CEO of Neurocrine. "The 100mg dose was statistically
superior to placebo as well as providing a clinically significant improvement
in tardive dyskinesia symptoms and importantly a very good safety profile. We
will now perform an additional Phase II study utilizing 100mg and higher
doses." The Full Research Report on Neurocrine Biosciences, Inc. - including
full detailed breakdown, analyst ratings and price targets - is available to
download free of charge at:
[http://www.investorsreports.com/report/2013-09-17/NBIX]

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