Magazin

2005-12-15

Sanofi Pasteur Announces Preliminary Trial Results for a First H5N1 Pre-Pandemic Influenza Vaccine Candidate With an Adjuvant


Lyon, France (ots/PRNewswire) -

- Data Show That the Vaccine is Safe, Demonstrates Immunogenicityand Provides Future Direction for Development

Sanofi pasteur, the vaccines business of the sanofi-aventis Group,announced today that preliminary results of clinical trials fieldedin France of an adjuvanted candidate H5N1 pre-pandemic influenzavaccine demonstrated a good immune response in a significant numberof volunteers. This is the first trial of an H5N1pre-pandemicinfluenza vaccine candidate that compared vaccines with and withoutadjuvants.

Preliminary results showed that the vaccine is safe andwell-tolerated in 300 healthy volunteers. A 30 microgram-dose with anadjuvant in a two-dose regimen demonstrated an immune response atlevels consistent with requirements of regulatory agencies forlicensure of seasonal influenza vaccine.

Sanofi pasteur characterized the preliminary results as a sign ofprogress and providing direction for further development of apandemic influenza vaccine. The company also noted that immuneresponses were detected in a number of volunteers receiving lowerdoses. Subsequent trials will explore different dosages, which may behelpful in answering questions about dose-sparing strategies andwhich is being widely discussed among the public health community.

The trial was sponsored by sanofi pasteur and fielded in threesites in France: Necker and Cochin Hospitals in Paris, and GarchesHospital, with Professor Jean-Louis Bresson as the principalinvestigator.

The vaccine used the reference strain provided by the UK'sNational Institute for Biological Standards and Control (NIBSC).Assays were performed at NIBSC and the UK Health Protection Agency.

As definitive results become available, they will be presented andpublished, as well as submitted to appropriate regulatory authoritiesfor review.

The data will be submitted as part of the company's core "mock up"vaccine dossier to the European Agency for the Evaluation ofMedicinal Products (EMEA). The core dossier has been developed instrict accordance to the EMEA guidelines. This process is expected toreduce the time necessary for approval of a pandemic vaccine inEurope once a strain is identified and a pandemic is declared.Follow-up studies, currently being planned, will be performed usingvaccine produced at large scale, which will mimic the manufacturingscale that will be used during a declared pandemic.

This is one of a number of initiatives by the company to helpprepare the world for the possibility of an influenza pandemic.

- Sanofi pasteur is investing in a major expansion of itsinfluenza vaccine production capacity in the US, and also of itsvaccine production capacity in France (Val de Reuil facility).

- Sanofi pasteur has entered into an agreement with the FrenchMinistry of Health to produce pre-pandemic vaccine in 2005 to createa1.4 million dose stockpile with the H5N1 candidate studied in thistrial. By this agreement, the company could also provide enoughvaccine to protect up to 28 million people in the event of a pandemicbeing declared, once the actual virus strain responsible isidentified.

- Sanofi pasteur has entered into a series of contracts with theUS government to increase that country's pandemic preparednessefforts. The contracts include investigational doses for clinicaltrials; bulk vaccine for stockpiles; establishment and maintenance oflaying flocks to enable year-round egg production (not justseasonal), as well as a contract to speed the production process fornew cell culture influenza vaccines, including the design of aUS-based cell-culture vaccine manufacturing facility.

- A contract has also been signed with the Australian governmentfor the supply of vaccine in the event of a pandemic influenzaoutbreak. There are also contacts concerning pandemic preparednessbetween sanofi pasteur and other governments in Europe and worldwide

- In addition, sanofi pasteur is the only vaccine manufacturer toparticipate in FLUPAN, an EU-funded collaboration. FLUPAN partnersinclude the National Institute for Biological Standards & Control(NIBSC -UK), the University of Reading (UK), Istituto Superiore diSanita, (Italy), the Health Protection Agency (UK), and theUniversity of Bergen (Norway). FLUPAN is intended to improve thelevel of pandemic preparedness in the EU. Sanofi pasteur is toproduce a vaccine to combat another strain with pandemic potential(H7N1) that will be used in a FLUPAN clinical study.

Influenza Overview

Influenza is a highly contagious virus that is spread easily fromperson to person, primarily when an infected individual coughs orsneezes. An influenza pandemic is a global epidemic of an especiallyvirulent virus with the potential for severe morbidity and mortality.According to the World Health Organization (WHO), the next pandemicis likely to result in 1 to 2.3 million hospitalizations and 280,000to 650,000 deaths in industrialized nations alone. Its impact willmost likely be even more devastating in developing countries.

About sanofi-aventis

Sanofi-aventis is the world's third-largest pharmaceuticalcompany, ranking number one in Europe. Backed by a world-class R&Dorganization, sanofi-aventis is developing leading positions in sevenmajor therapeutic areas: cardiovascular disease, thrombosis,oncology, metabolic diseases, central nervous system, internalmedicine, and vaccines. The sanofi-aventis Group is listed in Paris(EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofipasteur, the vaccines business of the sanofi-aventis Group,sold nearly a billion doses of vaccine in 2004, making it possible toprotect more than 500million people across the globe, which is about1.4 million per day. The company offers the broadest range ofvaccines, providing protection against 20 bacterial and viraldiseases. For more information, pleasevisit:www.sanofipasteur.com

Forward-Looking Statements

This press release contains forward-looking statements as definedin the Private Securities Litigation Reform Act of 1995.Forward-looking statements are statements that are not historicalfacts. These statements include financial projections and estimatesand their underlying assumptions, statements regarding plans,objectives and expectations with respect to future operations,products and services, and statements regarding future performance.Forward-looking statements are generally identified by the words"expect,""anticipates," "believes," "intends," "estimates," "plans"and similar expressions. Although sanofi-aventis' management believesthat the expectations reflected in such forward-looking statementsare reasonable, investors are cautioned that forward-lookinginformation and statements are subject to various risks anduncertainties, many of which are difficult to predict and generallybeyond the control of sanofi-aventis, that could cause actual resultsand developments to differ materially from those expressed in, orimplied or projected by, the forward-looking information andstatements. These risks and uncertainties include those discussed oridentified in the public filings with the SEC and the AMF made bysanofi-aventis, including those listed under "Risk Factors" and"Cautionary Statement Regarding Forward-Looking Statements" insanofi-aventis' annual report on Form 20-F for the year endedDecember 31, 2004. Other than as required by applicable law,sanofi-aventis does not undertake any obligation to update or reviseany forward-looking information or statements.

Sanofi-aventis subsidiaries in the United States includeSanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and SanofiPasteurInc.

Sanofi pasteur Alain BERNAL Vice President Corporate Communications Tel:+33-(0)4-37-37-78-97 Fax:+33-(0)4-37-37-72-76 Sanofi pasteur Len LAVENDA U.S.Media Relations Tel:+1-570-839-4446 Len.Lavenda@sanofipasteur.com

ots Originaltext: sanofi-aventis GroupIm Internet recherchierbar: http://www.presseportal.de

Contact:Sanofi pasteur, Alain BERNAL, Vice President Corporate Communications, Tel:+33-(0)4-37-37-78-97, Fax:+33-(0)4-37-37-72-76. Sanofi pasteur, Len LAVENDA, U.S.Media Relations, Tel:+1-570-839-4446, Len.Lavenda@sanofipasteur.com

sanofi-aventis Group

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   © 2003-2013 med-kolleg.de Gesundheitsportal SANOFI PASTEUR ANNOUNCES PRELIMINARY TRIAL RESULTS FOR A FIRST H5N1 PRE-PANDEMIC INFLUENZA VACCINE CANDIDATE WITH AN ADJUVANT