Sanofi Pasteur Delivers More H5N1 Vaccine for U.S. Government Pandemic Initiatives
New investigational doses include formulation with an adjuvant; Additional stockpile vaccine prepared
Feb 6, 2006
Swiftwater, Pa., and Lyon, France – February 6, 2006 – Sanofi pasteur, the vaccines business of the sanofi-aventis Group (NYSE: SNY), has delivered more H5N1 vaccine to the U.S. government including investigational doses formulated with an adjuvant.
Sanofi pasteur has shipped to the U.S. National Institutes of Health (NIH), part of the U.S Department of Health and Human Services (HHS), 15,000 investigational doses of a vaccine to protect against the H5N1 influenza strain. Prepared with different levels of antigen, the investigational doses will be used in the NIH’s clinical studies to determine the optimal formulation of the vaccine. The investigational doses include the use of the adjuvant, aluminum hydroxide (alum), that could increase the vaccine’s effectiveness and enable the use of less antigen in each dose. The end result could be a greater number of doses available to immunize more people.
In addition, the company has completed production of additional bulk-concentrate of the H5N1 vaccine antigen for the U.S. government stockpile. Once the optimal dosage is established, the bulk-concentrate antigen will be ready for final formulation and filling into doses.
The additional H5N1 bulk-concentrate vaccine represents a broadening of a contract the company signed in September 2005 with the U.S. Department of Health and Human Services (HHS) to produce a stockpile of the H5N1 vaccine valued at $100 million. The additional bulk concentrate vaccine just produced is valued at $50 million and will support U.S. Department of Defense requirements.
These activities are further examples of sanofi pasteur’s commitment to global pandemic preparedness. The H5N1 viral strain has been identified by global health authorities as being a potential cause of a pandemic.
The bulk-concentrate and the investigational doses were produced at sanofi pasteur’s U.S. site in Swiftwater, PA.
As the world leader in research, development and manufacturing of influenza vaccine, sanofi pasteur is actively involved in other projects in the U.S. and Europe with the goal of developing a vaccine to protect against a pandemic influenza virus.
Sanofi pasteur’s Global Commitment to Pandemic Preparation
In the U.S., sanofi pasteur has a number of pandemic-related agreements with the U.S. government involving development of pandemic vaccine stockpiles, production of investigational doses and the development cell-culture technology, including:
*In May 2004, sanofi pasteur contracted with the NIAID to produce 8,000 investigational doses of the H5N1 influenza strain. The doses were shipped to the NIAID earlier this year. The clinical studies for the vaccine are being conducted by the NIAID.
*In September 2004, the company signed a contract with HHS to produce two million doses of bulk vaccine derived from the H5N1 viral strain. The bulk doses were produced and are being stored, and can be formulated and filled upon government request.
*In November 2004, the HHS awarded a contract to sanofi pasteur to expand and safeguard the egg supply needed to produce influenza vaccine and to formulate each year investigational doses for a potential pandemic influenza vaccine.
*In April 2005, the HHS awarded a contract to sanofi pasteur to accelerate the development of a cell-culture influenza vaccine in the U.S. and the design of a U.S.-based cell-culture vaccine manufacturing facility.
*In September 2005, the HHS awarded a contract to sanofi pasteur to produce a vaccine to help protect against the H5N1 influenza virus strain. The $150 million contract calls for sanofi pasteur to manufacture the vaccine in bulk-concentrate form at its U.S. headquarters in Swiftwater, PA. The agreement provides for additional fees to be paid to sanofi pasteur for storage of the vaccine as well as for formulation and filling of the vaccine upon government request.
In Europe, sanofi pasteur initiated and runs a large range of projects.
•In France, sanofi pasteur sponsored the first clinical trials of an H5N1 pre-pandemic influenza vaccine candidate that compared vaccines with and without adjuvants. Preliminary results of the trial, announced on Dec. 15, 2005, demonstrated a good immune response in a significant number of volunteers. The trials are being undertaken to speed the time for regulatory review should a pandemic vaccine be needed quickly. The strain was provided by the U.K.'s National Institute for Biological Standards and Control (NIBSC). The clinical lots are being developed in collaboration with the French health authorities, NIBSC and the European Agency for the Evaluation of Medicinal Products (EMEA). The data from these studies will be used to submit a “mock dossier” submitted to the EMEA to accelerate the license approval process in the event of a pandemic.
•In France, sanofi pasteur was recently awarded a contract by the French Ministry of Health to produce pre-pandemic vaccine in 2005 to create a 1.4 million dose stockpile with the H5N1 candidate studied in this trial. By this agreement, the company could also provide enough vaccine to protect up to 28 million people in the event of a pandemic being declared, once the actual virus strain responsible is identified.
•Sanofi pasteur is the only vaccine manufacturer to participate in FLUPAN, a European Union (EU) funded collaboration. FLUPAN partners include NIBSC (UK), the University of Reading (UK), Istituto Superiore di Sanita (Italy), the Health Protection Agency (UK) and the University of Bergen (Norway). FLUPAN is intended to improve the level of pandemic preparedness in the EU Sanofi pasteur is to produce a vaccine to combat another strain with pandemic potential (H7N1) that will be used in a FLUPAN clinical study.
•A contract has also been signed with the Australian government for the supply of vaccine in the event of a pandemic influenza outbreak. There are also contacts concerning pandemic preparedness between sanofi pasteur and other governments in Europe and worldwide.
Sanofi-aventis is the world’s third-largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, sold more than a billion doses of vaccine in 2005, making it possible to protect more than 500 million people across the globe, which is about 1.5 million per day. The company offers the broadest range of vaccines, providing protection against 20 bacterial and viral diseases. For more information, please visit: www.sanofipasteur.com
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For further information: sanofi pasteur Alain BERNAL Vice-President Corporate Communications Tel: + 33-(0)4-37-37-78-97 Fax: +33-(0)4-37-37-77 89 sanofi pasteur Len LAVENDA U.S. Media Relations Tel: +1-570-839-4446 Len.Lavenda@sanofipasteur.com