2006-09-26

Sanofi pasteur Cell Culture-Based Seasonal Influenza Vaccine Enters First Clinical Trial


SWIFTWATER, Pennsylvania & LYON, France, September 26(ots/PRNewswire) -

- Flu Vaccine Based on New Technology Within U.S. GovernmentPreparedness Program

Sanofi pasteur, the vaccines business of the sanofi-aventis Group(NYSE: SNY), initiated its first clinical study today with a newgeneration of seasonal influenza vaccine produced using cell culturetechnology. This trial represents one of the company's initiatives todiversify flu vaccine manufacturing technologies.

The trial conducted in the United States is part of a contractawarded by the U.S. Department of Health and Human Services (HHS) toaccelerate the development of a new cell culture-based influenzavaccine.

"This trial will assess the safety and ability to generate animmune response of a cell culture-based vaccine that could provide animportant alternative to traditional egg-based flu vaccines," saidDennis Morrison, MD, Clinical Investigator at the first trial site,Bio-Kinetic Clinical Applications, Inc. in Springfield, Missouri. Theclinical study is the first step toward Sanofi pasteur filing aBiologics License Application with the Food and Drug Administration(FDA) to support development of a cell culture-based trivalent splitinactivated seasonal influenza vaccine.

The phase I clinical trial will be conducted on 100 healthyadults, 18-64 years of age. Half of the study participants willreceive the cell-based vaccine and the other half a traditionalegg-based control vaccine. "We are pleased to participate in a studythat evaluates next-generation influenza vaccines," said CynthiaStrout, MD, Clinical Investigator at the second trial site, theCoastal Carolina Research Center in Mt. Pleasant, South Carolina.

This vaccine was developed using PER.C6(R) cell culturetechnology, licensed from Dutch biotechnology company, Crucell N.V.Cell culture technology could allow Sanofi pasteur to diminishdependence on eggs while offering a reliable production technology.

The production scale potential of the PER.C6 cell line has beendemonstrated in a successful bioreactor run of 20,000 litres. Thisproject breaks new ground in vaccines technology by demonstratingeffective large scale production capacity using cell culture on acommercial scale. This scale-up process was achieved under asubcontracting agreement between sanofi pasteur and Lonza Biologicsplc, a biotechnology contract manufacturer and subsidiary of theLonza Group.

As the world leader in the research, development and manufactureof influenza vaccine, sanofi pasteur is actively involved in otherprojects in the U.S. and Europe with the goal of developing new andimproved influenza vaccines.

Seasonal Influenza Overview

Influenza is a highly infectious virus that spreads easily fromperson to person, primarily when an infected individual coughs orsneezes. According to the World Health Organization (WHO), 5-15% ofthe population is affected with upper respiratory tract infections inannual influenza epidemics. Hospitalisation and deaths mainly occurin high-risk groups (elderly, chronically ill (people with chronicconditions/illness). Although difficult to assess, these annualepidemics are thought to result in between three and five millioncases of severe illness and between 250, 000 and 500, 000 deathsevery year around the world. Most deaths currently associated withinfluenza in industrialised countries occur among the elderly over 65years of age.

About Lonza

Lonza is a chemical and biotechnology company headquartered inSwitzerland. Lonza is listed on the SWX Swiss Exchange. For moreinformation, please visit www.lonza.com.

About Crucell

Crucell N.V. is a Dutch biotechnology company (Euronext, NASDAQ:CRXL; Swiss Exchange: CRX). For more information, please visitwww.crucell.com <http://www.crucell.com/>.

About Sanofi pasteur and Crucell exclusive agreement

Sanofi pasteur, the vaccines business of the sanofi-aventis Group,entered on December 31, 2003 into a strategic and exclusive agreementwith Crucell N.V. to further develop, manufacture and marketcell-based novel influenza vaccine products based on Crucell'sproprietary PER.C6 cell line technology. The agreement covers bothpandemic and seasonal influenza vaccines.

Crucell's PER.C6 technology is a cell line developed for thelarge-scale manufacture of biological products including vaccines.

About sanofi-aventis

The sanofi-aventis Group is the world's third-largestpharmaceutical company, ranking number one in Europe. Backed by aworld-class R&D organisation, sanofi-aventis is developing leadingpositions in seven major therapeutic areas: cardiovascular disease,thrombosis, oncology, metabolic diseases, central nervous system,internal medicine and vaccines. The sanofi-aventis Group is listed inParis (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 possibleto protect more than 500 million people across the globe. The companyoffers the broadest range of vaccines compared to other vaccinecompanies, providing protection against 20 bacterial and viraldiseases. For more information, please visit: www.sanofipasteur.com<http://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 events,operations, products and services, and statements regarding futureperformance. Forward-looking statements are generally identified bythe words "expect," "anticipates," "believes," "intends,""estimates," "plans" and similar expressions.

Although sanofi-aventis' management believes that the expectationsreflected in such forward-looking statements are reasonable,investors are cautioned that forward-looking information andstatements are subject to various risks and uncertainties, many ofwhich are difficult to predict and generally beyond the control ofsanofi-aventis, that could cause actual results and developments todiffer materially from those expressed in, or implied or projectedby, the forward-looking information and statements. These risks anduncertainties include those discussed or identified in the publicfilings with the SEC and the AMF made by sanofi-aventis, includingthose listed under "Risk Factors" and "Cautionary Statement RegardingForward-Looking Statements" in sanofi-aventis' annual report on Form20-F for the year ended December 31, 2005. Other than as required byapplicable law, sanofi-aventis does not undertake any obligation toupdate or revise any forward-looking information or statements.

Sanofi pasteur Alain Bernal Vice-President Corporate Communications Tel: +33-4-37-37-78-97 Fax: +33-4-37-37-77 89 Sanofi pasteur Len Lavenda U.S. Media Relations Tel: +1-570-839-4446 Len.Lavenda@sanofipasteur.com

SWIFTWATER, Pennsylvania & LYON, France, September 26 /PRNewswire/ --

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

Contact:Sanofi pasteur, Alain Bernal, Vice-President Corporate Communications, Tel: +33-4-37-37-78-97, Fax: +33-4-37-37-77 89; Sanofi pasteur, LenLavenda, U.S. Media Relations, Tel: +1-570-839-4446, Len.Lavenda@sanofipasteur.com

sanofi-aventis Group

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Sanofi pasteur Cell Culture-Based Seasonal Influenza Vaccine Enters First Clinical Trial

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