Shionogi-ViiV Healthcare Announces Commitment to
Phase III Development Programme for Investigational
Once-Daily HIV Integrase Inhibitor
London, UK, 21 July 2010
– Shionogi-ViiV Healthcare LLC today announced that it will be
progressing its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 (‘572) into
Phase III clinical trials. ‘572 will be the only once-daily, unboosted integrase inhibitor in Phase III
clinical development.
This decision is based on promising results from two Phase IIb trials, SPRING-1 and VIKING, which
are being presented this week at the XVIII International AIDS Conference in Vienna, Austria (Abstract
Numbers THLBB205 & MOAB0105). These trials explored the efficacy of ‘572 in treatment-naïve HIV
subjects as well as in treatment-experienced subjects resistant to raltegravir. Further study in Phase III
is necessary to determine conclusively the safety, efficacy and resistance profile of ‘572.
“ViiV Healthcare is committed to developing promising new options for the treatment of HIV. As a
once-daily, unboosted integrase inhibitor, ‘572 could be an important new therapy to help people living
with HIV,” stated Dr. Dominique Limet, Chief Executive Officer, ViiV Healthcare. “‘572 has the potential
to offer naïve and experienced patients a new option, one which in Phase II has shown positive
antiviral activity and resistance results once a day. We hope to explore the potential further in the
Phase III studies, which are expected to begin this year.”
"We are very pleased with the progress of '572 in collaboration with ViiV Healthcare. Reaching the
important milestone of initiating Phase III studies is a credit to the hard work and commitment of teams
in both Shionogi and ViiV Healthcare. We look forward to starting the Phase III programme for ‘572
and demonstrating its potential to benefit HIV infected patients across the treatment spectrum,” said
Dr. Sapan Shah, President & CEO, Shionogi Inc.
About the Phase IIb Trials
SPRING-1 Study Design (Abstract THLBB205)
SPRING-1 is an ongoing Phase IIb, multicenter, partially-blinded, dose-ranging study comparing ‘572
to efavirenz (EFV) in 205 treatment-naïve subjects. Individuals were randomized 1:1:1:1 to 10 mg, 25
mg or 50 mg of ‘572 or EFV 600 mg once daily in combination with either tenofovir/emtricitabine
(TDF/FTC) or abacavir/lamivudine (ABC/3TC).
VIKING Study Design (Abstract MOAB0105)
The VIKING study is a Phase IIb multicenter, open-label, single arm study designed to assess the
antiviral activity, safety and tolerability of ‘572 in treatment-experienced, HIV-infected adult subjects
with raltegravir (RAL) resistance as short term functional monotherapy, and over a 24-week treatment
period with optimized background therapy. Genotypic and phenotypic changes in HIV integrase were
also evaluated.
The study enrolled 27 subjects with screening plasma HIV-1 RNA ≥1000c/mL showing genotypic
resistance to RAL and at least two other antiretroviral classes. All subjects had RAL-associated
mutations at screening. Subjects received ‘572 50mg QD while continuing their failing regimen
(without RAL) to Day 11 when the background regimen was optimized, where feasible, and ‘572
continued.
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 IIb clinical development. Shionogi-ViiV Healthcare LLC is also
developing second-generation integrase inhibitors, including S/GSK1265744, currently in Phase II
development.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established 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.
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 .
Enquiries:
UK Media Enquiries:
Philip Thomson
(020) 8047 5502
Claire Brough
(020) 8047 5502
Rebecca Hunt
(020) 8380 6275
US Media Enquiries:
Marc Meachem
(919) 483 5005
GSK European Analyst/Investor Enquiries:
David Mawdsley
(020) 8047 5564
Sally Ferguson
(020) 8047 5543
Gary Davies
(020) 8047 5503
GSK US Analyst/ Investor Enquiries:
Tom Curry
(215) 751 5419
Jen Hill Baxter
(215) 751 7002
Shionogi & Co., Ltd. Enquiries
Corporate
Communications
+81 6 6209 7885
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 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, 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 kinds.
