NOTE: The following statement was distributed globally by ViiV
In Canada, the safety and efficacy of S/GSK1349572 ('572) is currently
under investigation; marketing authorization from Health Canada has not
yet been obtained.
MISSISSAUGA, ON, Feb. 7 /CNW/ - Shionogi-ViiV Healthcare, LLC announced
today that the first patient has entered the clinical study, SINGLE
(ING114467), designed to support a new fixed-dose combination (FDC)
therapy for the treatment of HIV. The new investigational regimen,
known as 572-Trii, will combine the investigational integrase inhibitor
S/GSK1349572 ('572) and ViiV Healthcare's combination nucleoside
reverse transcriptase inhibitor (NRTI) Kivexa®/Epizcom® (ABC/3TC).
"ViiV Healthcare's goal is to understand and be responsive to the needs
of people living with HIV," stated Dominique Limet, Chief Executive
Officer, ViiV Healthcare. "With this programme, we are seeking to
create an integrase-based, once-daily fixed dose combination that helps
meet patient needs. We know that even with the successes of current
therapies, patients still need additional treatment options and we will
continue to evaluate existing and pipeline compounds for new
"The study of a fixed-dose combination therapy that includes '572 is a
signal of Shionogi and ViiV Healthcare's confidence in the compound's
potential," said Dr. Sapan Shah, President & CEO, Shionogi Inc. "We're
optimistic that '572 will continue to show promise through this
research and in the other ongoing Phase III studies that are evaluating
it in other HIV treatment regimens."
About the Study: SINGLE (ING114467)
The SINGLE study (ING114467) is a multi-centre, multinational,
double-blind, two arm study designed to compare the efficacy and safety
of 572-Trii ('572 plus ABC/3TC) with that of
efavirenz/tenofovir/emtricitabine (EFV/TDF/FTC). This study will
include approximately 800 HIV-1 infected treatment-naïve patients.
The primary objective for the SINGLE study will be to demonstrate the
antiviral activity of 572-Trii once-daily therapy compared to
EFV/TDF/FTC over 48 weeks. Secondary objectives include the assessment
of the tolerability, long-term safety, and antiviral and immunologic
activity of 572-Trii once-daily compared to EFV/TDF/FTC over 96
weeks. Investigators will also evaluate viral resistance in patients
experiencing virologic failure.
Together with the planned FDC bioequivalence study (ING114580) comparing
the 572-Trii FDC tablet with '572 plus ABC/3TC, the SINGLE study is
designed to support a regulatory filing for 572-Trii as a new fixed
dose combination of '572/ABC/3TC.
KIVEXA/EPZICOM (abacavir/lamivudine) is a once-a-day HIV medication that
combines abacavir sulfate and lamivudine in a single tablet and is
indicated for the treatment of HIV-1 infection in adults.
Important Information about KIVEXA/EPZICOM
KIVEXA/EPZICOM, in combination with other antiretroviral agents, is
indicated for the treatment of HIV-1 infection in adults.
KIVEXA/EPZICOM is one of 3 medicines containing abacavir. Before
starting KIVEXA/EPZICOM, your healthcare professional will review your
medical history in order to avoid the use of abacavir if you have
experienced an allergic reaction to abacavir in the past.
In one study, more patients had a severe hypersensitivity reaction in
the abacavir once-daily group than in the abacavir twice-daily group.
KIVEXA/EPZICOM should not be used as part of a triple-nucleoside
KIVEXA/EPZICOM does not cure HIV infection/AIDS or prevent passing HIV
Important Safety Information
KIVEXA/EPZICOM contains abacavir, which is also contained in ZIAGEN®
(abacavir sulfate) and TRIZIVIR® (abacavir sulfate, lamivudine, and
zidovudine). Patients taking KIVEXA/EPZICOM may have a serious allergic
reaction (hypersensitivity reaction) that can cause death. The risk of this allergic reaction is much higher if one has a gene
variation called HLA-B*5701 than if one does not. Your doctor can
determine with a blood test if you have this gene variation. If you get
a symptom from 2 or more of the following groups while taking
KIVEXA/EPZICOM, call your doctor right away to determine if you should
stop taking this medicine:
Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
Generally ill feeling, extreme tiredness, or achiness
Shortness of breath, cough, or sore throat
Carefully read the Warning Card that your pharmacist gives you and carry
it with you at all times.
If you stop KIVEXA/EPZICOM because of an allergic reaction, NEVER take
KIVEXA/EPZICOM or any other abacavir-containing medicine (ZIAGEN,
TRIZIVIR) again. If you take EPZICOM or any other abacavir-containing medicine again
after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.
If you stop KIVEXA/EPZICOM for any other reason, even for a few days,
and you are not allergic to KIVEXA/EPZICOM, talk with your healthcare
professional before taking it again. Taking EPZICOM again can cause a
serious or life-threatening reaction, even if you never had an allergic
reaction before. If your healthcare professional tells you that you can take
KIVEXA/EPZICOM again, start taking it when you are around medical help or people who can call
a doctor if you need one.
A build-up of lactic acid in the blood and an enlarged liver, including
fatal cases, has been reported.
Do not take KIVEXA/EPZICOM if your liver does not function normally.
Some patients infected with both hepatitis B virus (HBV) and HIV have
worsening of hepatitis after stopping lamivudine (a component of
KIVEXA/EPZICOM). Discuss any change in treatment with your doctor. If
you have both HBV and HIV and stop treatment with KIVEXA/EPZICOM, you
should be closely monitored by your doctor for at least several months.
Worsening of liver disease (sometimes resulting in death) has occurred
in patients infected with both HIV and hepatitis C virus who are taking
anti-HIV medicines and are also being treated for hepatitis C with
interferon with or without ribavirin. If you are taking KIVEXA/EPZICOM
as well as interferon with or without ribavirin and you experience side
effects, be sure to tell your doctor.
When you start taking HIV medicines, your immune system may get stronger
and could begin to fight infections that have been hidden in your body,
such as pneumonia, herpes virus, or tuberculosis. If you have new
symptoms after starting your HIV medicines, be sure to tell your
Changes in body fat may occur in some patients taking antiretroviral
therapy. These changes may include an increased amount of fat in the
upper back and neck ("buffalo hump"), breast, and around the trunk.
Loss of fat from the legs, arms, and face may also occur. The cause and
long-term health effects of these conditions are not known at this
Some HIV medicines, including those containing abacavir (ZIAGEN,
KIVEXA/EPZICOM or TRIZIVIR), may increase one's risk of heart attack.
If one has heart problems, smokes, or suffers from diseases that
increase the risk of heart disease such as high blood pressure, high
cholesterol, or diabetes, they should tell their doctor.
The most common side effects seen with the drugs in KIVEXA/EPZICOM dosed
once-daily were allergic reaction, trouble sleeping, depression,
headache, tiredness, dizziness, nausea, diarrhea, rash, fever, stomach
pain, abnormal dreams, and anxiety. Most of the side effects do not
cause people to stop taking KIVEXA/EPZICOM.
For additional important information about KIVEXA/EPZICOM please href="http://www.epzicom.com">visit www.epzicom.com. For additional important information about ZIAGEN please href="http://www.treathiv.com">visit www.treathiv.com.
About Shionogi-ViiV Healthcare, LLC
'572 is the lead compound in Shionogi-ViiV Healthcare LLC. It is
currently the only once-daily, unboosted integrase inhibitor in Phase
III clinical development. Shionogi-ViiV Healthcare LLC is also
developing other second-generation integrase inhibitors, including
S/GSK1265744, currently in Phase II 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-inc.com.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in
November 2009 by GlaxoSmithKline (NYSE: GSK) and Pfizer (NYSE: PFE)
dedicated to delivering advances in treatment and care for people
living with HIV. Our 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.
Based in Montreal, QC, ViiV Healthcare ULC is a wholly owned subsidiary
of ViiV Healthcare LLC.
Cautionary statement regarding forward-looking statements
GlaxoSmithKline disclosure notice: 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 'Business Review' in the company' s Annual Report on
Form 20-F for 2009.
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
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, 2009 and in its reports on Form 10-Q and Form 8-K.
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 kind.
SOURCE ViiV Healthcare ULC
For further information:
|Canadian Media inquiries: || || ||Michelle Smolenaars Hunter || || ||(905) 819 3363|
|UK Media inquiries: || || ||Rebecca Hunt |
| || ||(020) 8380 6275|
(020) 8047 5502
|US Media inquiries: || || ||Marc Meachem || || ||(919) 483 5005|
| || || || || || || |
|GSK European Analyst/Investor inquiries: || || ||Sally Ferguson || || ||(020) 8047 5543|
| || || ||Gary Davies || || ||(020) 8047 5503|
| || || || || || || |
| || || ||Tom Curry || || ||(215) 751 5419|
|GSK US Analyst/ Investor inquiries: || || ||Jen Hill Baxter || || ||(215) 751 7002|
| || || || || || || |
|Shionogi & Co., Ltd. Enquiries || || ||Corporate Communications || || ||+81 6 6209 7885|