Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announces it is ready to support public health efforts to respond to the emergence of the new A(H1N1) influenza strain following the decision made by the World Health Organization (WHO) to raise the pandemic alert level from Phase 5 to Phase 6, the highest level of alert in the WHO global influenza preparedness plan.

“By committing to develop and supply a vaccine against the new influenza A(H1N1) strain, Sanofi Pasteur supports the fight against pandemic influenza led by the WHO, the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) in the United States, the European Institutions, the French Ministry of Health and other national and international health authorities around the world”, said Wayne Pisano, President and CEO of Sanofi Pasteur. “Sanofi Pasteur remains in continuous communication with these health authorities to help develop a tailored response to local public health needs”.

As the world’s largest supplier of influenza vaccine, Sanofi Pasteur is currently implementing its internal pandemic preparedness plans to ensure its continued ability to fulfill its public health mission to produce the largest number of doses of vaccine in the shortest time frame to face the threat of pandemic influenza while maintaining the production of other life-saving vaccines.

The company received the new A(H1N1) seed virus from WHO International Reference Centers, and has begun preparation of a working seed to be used for vaccine production. Sanofi Pasteur currently estimates it will have the first bulk concentrate vaccine within four to six months. This vaccine would help prevent the spread of the new influenza A (H1N1) virus strain. Its availability would be subject to regulatory approval.

Sanofi Pasteur received an order from the U.S. Department of Health and Human Services (HHS) on May 25, 2009 for the supply of an A(H1N1) influenza vaccine.

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Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced it has received the first of what is expected to be a series of orders from the U.S. Department of Health and Human Services (HHS) to commence production of a vaccine to help protect against the new influenza A(H1N1) virus. This order from HHS was issued pursuant to an existing pandemic stockpile contract between Sanofi Pasteur and the U.S. government that allows HHS to purchase vaccines for viruses with pandemic potential. In addition to this initial HHS order, the company is in discussions with other governments to address their needs for A(H1N1) vaccine.
The HHS order provides for the production of the bulk vaccine and related activities. The dosage requirements for the new vaccine are yet to be determined and will be based on clinical trials, which could begin as early as August. Final formulation, filling and distribution of the vaccine also have not been established at this time. The order is in the amount of $190 million.

“This initial order for A(H1N1) vaccine received today under our existing contract is part of a major effort by Sanofi Pasteur to support global public health efforts to prepare the world for the possibility of an influenza pandemic,” said Wayne Pisano, President and CEO of Sanofi Pasteur. “Production of a new vaccine is not a simple task and there are a number of necessary and complex steps that must be taken before a vaccine can be made available to the public, but we have experience on our side. Previously, we developed and licensed the first pre-pandemic vaccine for H5N1 and we look forward to further demonstrating our experience and expertise in vaccine development as we prepare for this new threat from A(H1N1).”

Sanofi Pasteur is awaiting receipt of the seed virus to be used for vaccine production from the U.S. Centers for Disease Control and Prevention (CDC). Once the seed is received, Sanofi Pasteur will begin development efforts to prepare a working seed for vaccine production. Sanofi Pasteur is prepared to commence commercial scale production in June following certification of the working seed by the U.S. Food and Drug Administration (FDA). The company currently estimates it will have the first bulk concentrate vaccine in a few months. However, the company will be better able to determine the timing once the seed virus is received and development of working seed is underway.

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