Shionogi-ViiV Healthcare Announces Commitment to Phase III Development Program for Investigational Once-Daily HIV Integrase Inhibitor

LONDON, July 21 /PRNewswire/ -- 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-naive 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 naive 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 program 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-naive 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.

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.

SOURCE Shionogi-ViiV Healthcare LLC