Swine flu vaccine production underway

This just in from my favorite Big Phara Newsletter, FiercePharma

Using its baculovirus and insect cell manufacturing technology, Protein Sciences estimates that it could be delivering H1N1 swine flu vaccine by mid July. That includes quality testing time, the manufacturer says.

The World Health Organization last week raised the pandemic level to phase 6, calling for the implementation of “individual, societal, and pharmaceutical measures” as well as implementation of contingency plans for health systems. WHO continues to recommend no restrictions on travel and no border closures, however.

Some 100,000 doses of Protein Sciences’ PanBlok vaccine, being produced from this week forward, will be targeted for clinical trials and for vaccinations in countries that have granted regulatory clearance.

The company says it is in discussions with “various parties” in the U.S. and abroad to conduct human clinical trials. Such studies will evaluate different doses, two dosing regimens, and a formulation of the vaccine containing adjuvant.

Meanwhile, following the WHO announcement, GlaxoSmithKline says it is going to increase production of its anti-viral Relenza, and continue developing a swine flu vaccine. Separately, Chinese vaccine maker Sinovac Biotech says it hopes to put its H1N1 vaccine through its first clinical trial by the end of July.

The following is a GSK  press release is intended for business journalists and analysts/investors.

GlaxoSmithKline update: A (H1N1) influenza

Issued: Friday 12 June 2009, London, UK

• WHO raises influenza pandemic alert to phase 6
• GSK has started development ofa new candidate A (H1N1) adjuvanted influenza vaccine
• Production of seasonal influenza vaccine for 2009/2010 Northern Hemisphere influenza season continues in parallel

The World Health Organisation (WHO) has announced it has raised the current level of influenza pandemic alert from phase 5 to phase 6.  As stated by the WHO, phase 6 indicates that there now is a pandemic ongoing caused by the new A (H1N1) influenza virus.  The WHO has stated in their current assessment of the situation that this pandemic is currently of a moderate severity.

In addition to increasing production and supply of the anti-viral medication, Relenza (zanamivir), the company continues to focus efforts on the development of a candidate A (H1N1) adjuvanted influenza vaccine.

Following receipt of the seed strain from the WHO at the end of May, the company has begun the process necessary for development of the new vaccine at both the Canadian and German manufacturing sites.  The first step for manufacturing an influenza vaccine is to prepare the seed strain for production, which will take several weeks.  The company will then start production of the new candidate A (H1N1) influenza vaccine.  The first doses of the A (H1N1) vaccine antigen are expected to be available in four to six months time, subject to regulatory approval.

GSK remains committed to supporting governments and health authorities around the world respond to the emergence of the new A (H1N1) influenza virus, including addressing the needs of developing countries.  GSK has offered to convert its intended donation to the WHO of 50 million doses of H5N1 pre-pandemic vaccine to the new candidate A (H1N1) adjuvanted influenza vaccine once production begins.  As capacity increases, GSK will supply the vaccine to developing countries under a tiered-pricing policy based on World Bank classifications and GAVI eligibility.

In parallel,GSK will continue production of its seasonal influenza vaccine supply for the 2009/2010 Northern Hemisphere influenza season.  GSK also continues to supply vaccine for use in the Southern Hemisphere as it enters the winter season this year.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

Cautionary statement regarding forward-looking statements
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 2008.

US Media enquiries: Nancy Pekarek (919) 483 2839 Mary Anne Rhyne (919) 483 2839 Kevin Colgan (919) 483 2839 Lisa Behrens (919) 483 2839

– read the Protein Sciences announcement

-From Reuters – China’s Sinovac enters race for flu vaccine