NOTE: The following statement was distributed globally by ViiV
In Canada, the safety and efficacy of dolutegravir is currently under
investigation; marketing authorization from Health Canada has not yet
LAVAL, QC, July 18, 2012 /CNW/ - Shionogi-ViiV Healthcare LLC announced
that initial results have been received from the Phase III SINGLE
(ING114467) study of the investigational integrase inhibitor
dolutegravir in treatment-naïve adults with HIV-1. The study
demonstrated superiority of the dolutegravir-based regimen compared to
the single tablet regimen Atripla®. At 48 weeks, 88% of study participants on the dolutegravir regimen were
virologically suppressed (<50 copies/mL) vs. 81% of participants on the
single tablet regimen Atripla® [difference and 95% CI; 7.4% (+2.5% to
+12.3%); difference in the primary endpoint was statistically
significant, p=0.003]. Differences in efficacy were primarily driven by
a higher rate of discontinuation due to adverse events on the Atripla®
arm. The SINGLE study was designed to demonstrate non-inferiority of
the dolutegravir-based regimen versus Atripla®, and the primary
analysis met this criterion. Statistical superiority was concluded as
part of a subsequent, pre-specified testing procedure.
SINGLE is an ongoing double blind, double dummy study designed to
compare the efficacy and safety of two antiretroviral regimens:
dolutegravir 50mg plus abacavir/lamivudine (Kivexa®/Epzicom®) versus Atripla® (tenofovir/emtricitabine/efavirenz). The primary
endpoint was the proportion of study participants with undetectable
HIV-1 RNA (<50c/mL) at 48 weeks; 414 treatment-naïve study participants
were randomised and exposed to the dolutegravir-based regimen and 419
to the Atripla® arm. Overall, 2% of subjects on the dolutegravir-based
regimen discontinued due to adverse events vs. 10% of those receiving
the Atripla® regimen. The most common drug related adverse events on
Atripla® were in the nervous system System Organ Class (reported by 41%
of Atripla® recipients, vs. 15% of participants receiving the
dolutegravir-based regimen), while the most common drug related adverse
events on the dolutegravir-based regimen were in the gastrointestinal
system organ class (reported by 22% of subjects receiving the
dolutegravir-based regimen and 22% of subjects receiving Atripla®).
"Taken together with the results of the SPRING-2 trial, the SINGLE
findings suggest that, if approved by regulators, a treatment regimen
containing dolutegravir may offer people living with HIV an important
additional first line option in the future" said Dr. Tsutae "Den"
Nagata, Chief Medical Officer, Shionogi & Co., Ltd.
"This study represents an important milestone in the development of
dolutegravir-based regimens, including a single-tablet regimen, and
also for the Shionogi-ViiV Healthcare joint venture. We look forward to
receiving further safety and efficacy data from two Phase III studies
in treatment experienced patients to continue to build a comprehensive
picture of the role of dolutegravir in the treatment of HIV" said Dr
John Pottage, Chief Medical Officer, ViiV Healthcare.
Full results of this study, including key secondary endpoints, will be
presented at upcoming scientific meetings. SINGLE is the second of four
Phase III studies that are due to be reported in 2012. Data from the
clinical trial SPRING-2 (ING113086) were announced in April 2012. Data
from VIKING-3 (ING112574) and SAILING (ING111762) in
treatment-experienced patients will be received later this year and
will allow further characterization of the profile of dolutegravir.
These studies are designed to support a future regulatory filing for
About SINGLE (ING114467)
SINGLE is an ongoing phase III, randomised, multi-centre, multinational,
double-blind, double dummy study designed to compare the efficacy and
safety of dolutegravir plus abacavir/lamivudine compared to Atripla® in
treatment-naïve patients. The primary objective for SINGLE is to
demonstrate the antiviral activity of dolutegravir plus
abacavir/lamivudine once-daily therapy compared to Atripla® over 48
weeks. As per study design, trial participants will continue on blinded
therapy in order to assess the tolerability, long-term safety, and
antiviral and immunologic activity of dolutegravir plus
abacavir/lamivudine once-daily compared to Atripla® over 96 weeks.
Investigators will also evaluate viral resistance in patients
experiencing virologic failure.
S/GSK1349572 (dolutegravir) is an investigational integrase inhibitor
(INI) currently in development by Shionogi-ViiV Healthcare LLC for the
treatment of HIV. Dolutegravir does not require an additional 'booster'
drug be added to the regimen. Integrase inhibitors block HIV
replication by preventing the viral DNA from integrating into the
genetic material of human immune cells (T-cells). This step is
essential in the HIV replication cycle and is also responsible for
establishing chronic infection. Given the stage of development of this
investigational HIV therapy, the full picture of the efficacy and
safety of dolutegravir has not been conclusively determined.
About Shionogi-ViiV Healthcare LLC
The Shionogi-ViiV Healthcare LLC is a joint venture between Shionogi &
Co., Ltd. and ViiV Healthcare Ltd., a global company with a sole focus
on HIV established in 2009 by GlaxoSmithKline and Pfizer, Inc.
Dolutegravir is the lead compound in the Shionogi-ViiV Healthcare LLC
partnership. Shionogi-ViiV Healthcare LLC is also developing another
integrase inhibitor which is at an earlier stage of development.
About Shionogi & Co., Ltd
Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major
research-driven pharmaceutical company dedicated to placing the highest
value on patients. Shionogi's Research and Development currently
targets three therapeutic areas: Infectious Diseases, Pain, and
Metabolic Syndrome. The Company is the originator of innovative
medicines which have been successfully delivered to millions of
patients worldwide. In addition, Shionogi is engaged in new research
areas such as allergy and cancer. Contributing to the health of
patients around the world through development in these therapeutic
areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp. For more information on Shionogi Inc. headquartered in Florham Park,
NJ, please visit www.shionogi.com.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in
November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE)
dedicated to delivering advances in treatment and care for people
living with HIV. The company's aim is to take a deeper and broader
interest in HIV/AIDS than any company has done before and take a new
approach to deliver effective and new HIV medicines as well as support
communities affected by HIV. For more information on the company, its
management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.
Shionogi forward-looking statement: This announcement contains forward-looking statements. These statements
are based on expectations in light of the information currently
available, assumptions that are subject to risks and uncertainties
which could cause actual results to differ materially from these
statements. Risks and uncertainties include general domestic and
international economic conditions such as general industry and market
conditions, and changes of interest rate and currency exchange rate.
These risks and uncertainties particularly apply with respect to
product-related forward-looking statements. Product risks and
uncertainties include, but are not limited to, completion and
discontinuation of clinical trials; obtaining regulatory approvals;
claims and concerns about product safety and efficacy; technological
advances; adverse outcome of important litigation; domestic and foreign
healthcare reforms and changes of laws and regulations. The company
disclaims any intention or obligation to update or revise any
forward-looking statements whether as a result of new information,
future events or otherwise. This announcement contains information on
pharmaceuticals (including compounds under development), but this
information is not intended to make any representations or
advertisements regarding the efficacy or effectiveness of these
preparations nor provide medical advice of any kinds.
GlaxoSmithKline Cautionary statement regarding forward-looking
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including those
made in this announcement, are subject to risks and uncertainties that
may cause actual results to differ materially from those projected.
Factors that may affect GSK' s operations are described under 'Risk
factors' in the 'Financial review & risk' section in the company's
Annual Report 2011 included as exhibit 15.2 to the company's Annual
Report on Form 20-F for 2011.
Pfizer disclosure notice: Pfizer assumes no obligation to update any forward-looking statements
contained in this release as a result of new information or future
events or developments. This release contains forward-looking
information about Pfizer, GlaxoSmithKline and ViiV Healthcare and about
the prospects of the companies, including revenues from in-line
products and the potential benefits of product candidates that will be
contributed to that company, as well as the potential financial impact
of the transaction. Such information involves substantial risks and
uncertainties including, among other things, decisions by regulatory
authorities regarding whether and when to approve any drug applications
that have been or may be filed for such product candidates as well as
their decisions regarding labeling and other matters that could affect
the availability or commercial potential of such product candidates;
and competitive developments.
A further list and description of risks and uncertainties can be found
in Pfizer's Annual Report of Form 10-K for the fiscal year ended
December 31, 2011 and in its reports on Form 10-Q and Form 8-K.
SOURCE GlaxoSmithKline Inc.
For further information:
ViiV UK Media enquiries:
Camilla Bull +44 (0) 20 8380 6226
David Daley +44 (0) 20 8047 5502
ViiV US/Canada Media enquiries:
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Sally Ferguson +44 (0) 20 8047 5543
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James Dodwell + 44 (0) 20 8047 2406
Jeff McLaughlin + 1 215 751 7002
Ziba Shamsi + 44 (0) 20 8047 3289
Shionogi & Co., Ltd. enquiries:
Corporate Communications +1 816 6209 7885