GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen; First Clinical Trials of Candidate Pre-pandemic Flu Vaccine to Start

PHILADELPHIA -- GlaxoSmithKline, one of the world's largest vaccine manufacturers, announces that the Department of Health and Human Services (HHS) has placed another order to purchase bulk H5N1 antigen for the US national stockpile of pre-pandemic vaccines. The company also announced the start of the first North American pre-pandemic vaccine trials in the company's global pre-pandemic influenza program.

The company has received a second task order for 22.5 million doses of 15 mcg H5N1 bulk vaccine antigen from the HHS under a contract awarded in November. This is in addition to the 5 million doses of H5N1 clade 2 bulk antigen at 15 mcg HA/dose ordered in November 2006. The additional task order procures an additional 9 million doses of H5N1 clade 2 bulk vaccine produced in the 2006 manufacturing campaign and 13.5 million doses of H5N1 clade 2 bulk vaccine expected to be produced in the 2007 manufacturing campaign.

Under the terms of the contract, GSK will manufacture the bulk vaccine product at the GSK manufacturing site in Ste. Foy, Canada and store bulk H5N1 antigen at the GSK site in Marietta, Pa. Terms of the contract also state that GSK may be directed by HHS to formulate this bulk antigen at some point in the future. Additionally, HHS also has the option to purchase pre-pandemic vaccines together with one of GSK's proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response. Funding for this contract is provided through the Office of Biomedical Advanced Research and Development Authority (BARDA) in the Assistant Secretary for Preparedness and Response (ASPR).

David Stout, president of pharmaceutical operations for GlaxoSmithKline said, "We applaud the U.S. government's proactive steps in protecting American citizens against this potential public health threat. We are committed to helping governments and public health officials around the world effectively respond to the global threat of a flu pandemic and we are pleased to be working with the U.S. government in its preparedness efforts."

Today also marked the start of the first pre-pandemic vaccine trials involving GSK's proprietary adjuvanted H5N1 vaccine in North America. The vaccine used in these trials will be produced at the company's North American manufacturing facility in Quebec, Canada. These U.S. studies are supported by a contract from BARDA/ASPR/HHS awarded in January 2007 for the advanced development of antigen-sparing pandemic influenza vaccines toward U.S.-licensure with a commitment to U.S. production of 150 million doses of pandemic vaccine within six months of a pandemic onset.

GSK's first North American pre-pandemic vaccine trial will be a Phase I/II study that evaluates its H5N1 antigen alone and in combination with one of its proprietary Adjuvant Systems, in 675 subjects. This Phase I/II study is expected to lead into a larger, multi-center, Phase III trial -- one of the largest in North America -- which is expected to enroll approximately 4,400 subjects later in 2007.

This Phase I/II study, which will be conducted in seven states in the United States and two provinces in Canada, is an observer-blind, randomized, active-controlled trial that will evaluate the safety and immunogenicity of two consecutive doses of H5N1 pre-pandemic vaccine. The vaccine containing H5N1 antigen alone will be evaluated against a vaccine containing H5N1 antigen in combination with the Adjuvant System, in 675 adult volunteers aged between 18 and 64 years. Results from this study will be available in early 2008.

Source: GlaxoSmithKline