PHILADELPHIA, May 4 /PRNewswire-FirstCall/ -- GlaxoSmithKline has been awarded a $274 million contract from the U.S. Department of Health and Human Services (HHS) to speed the development of new cell culture-based seasonal and pandemic influenza vaccines and to scale-up cell culture manufacturing capability at its Marietta, PA facility.
"The contract awarded to GSK, a global leader in influenza vaccines, underlines the company's commitment to support the efforts of the U.S. government in protecting public health through increased and diversified vaccine production capacities for seasonal as well as pandemic flu vaccines," said David Stout, President of Pharmaceuticals of GlaxoSmithKline.
Under the terms of the contract, GSK will be reimbursed by HHS for costs up to $274 million incurred over the five-year contract, payable through the Department's Office of Public Health Emergency Preparedness, Office of Research and Development Coordination.
Within the five-year contract period, GSK will undertake clinical programs to support filing of a Biologics License Application for a cell culture-based trivalent seasonal influenza vaccine, and to complete Phase II studies of an H5N1 cell culture-based pandemic influenza vaccine.
In addition to the contract work for HHS, GSK will continue to make an investment in excess of $100 million at its Marietta, PA facility to establish a domestic cell culture flu vaccine manufacturing site.
Under the HHS agreement, GSK's research efforts will focus on cell culture-based manufacturing technologies. The development of effective cell culture-based influenza vaccines is an important step forward to fight both seasonal and pandemic flu. GSK plans to bring its considerable expertise to this development program for the benefit of children, adults, and the elderly. The company's research efforts will be focused on cell culture-based manufacturing technologies which are intended to offer a number of potential advantages over traditional egg-based manufacturing processes, including increased flexibility in generating a rapid surge in production capacity and elimination of the dependence on hens' eggs in the longer term.
GlaxoSmithKline, a leader in Flu treatment and preparedness
GlaxoSmithKline has an active research and development program targeted at both seasonal and pandemic influenza, and has recently committed over $2 billion to expand capacity for manufacturing flu vaccine and its anti-viral influenza treatment Relenza(R) (zanamivir for inhalation).
GSK was the first company to submit a "mock-up" dossier for an egg-based pandemic vaccine with traditional alum adjuvant to European regulators in December 2005. Should a pandemic flu strain be identified by the World Health Organization, a variation to the dossier would allow rapid registration and production of a pandemic vaccine more closely matched to the circulating pandemic strain. At the end of March, the company announced the start of an international clinical trial program to test two egg-based pandemic vaccines against the H5N1 strain of the avian influenza virus in humans.
In North America, GSK has acquired a major influenza vaccine manufacturer, ID Biomedical Corporation, which provides GSK with a significant increase in flu vaccine manufacturing capacity.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.
GlaxoSmithKlineCONTACT: US Media inquiries - Nancy Pekarek, +1-215-751-7709, Mary AnneRhyne, +1-919-483-2839, Patty Seif, +1-215-751-7709, or Gaile Renegar,+1-215-751-7709; UK Media inquiries - Phil Thomson, (020) 8047 5502, orAlice Hunt, (020) 8047 5502; US Investor inquiries - Frank Murdolo,+1-215-751-7002, or Tom Curry, +1-215-751-5419; UK Investor inquiries -Duncan Learmouth, (020) 8047 5540, Anita Kidgell, (020) 8047 5542, JenHill, (020) 8047 5543, or David Mawdsley, (020) 8047 5564, all ofGlaxoSmithKline
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