Sanofi Pasteur Seeks to Broaden Age Group For New Vaccine to Protect Against Meningococcal Disease
Lyon, France (ots/PRNewswire)
- Submits Supplemental License Application
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, is seeking US government approval to broaden the age indication for its new meningococcal vaccine Menactra(TM) (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine). The company has filed a supplemental application with the US Food and Drug Administration (FDA) to amend the vaccine's license to include children aged 2 through 10 years. The FDA licensed Menactra vaccine on January 14 this year for use among 11 through 55 year olds.
Menactra vaccine is the world's first quadrivalent conjugate vaccine licensed for the prevention of meningococcal disease and is designed to offer protection against four serogroups of Neisseria meningitidis (A, C, Y, and W-135), the bacterium that causes meningococcal infection.
"The additional age indication would help protect a younger segment of the population against a serious and devastating disease," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at sanofi pasteur US. "At the same time, it has the potential benefit of increasing meningococcal immunization rates because the 2-10 age group generally are seen by a pediatrician on a regular basis for the recommended schedule of childhood vaccinations."
Studies have demonstrated that serogroups C, Y and W-135 account for about 48% of meningococcal disease in 2 through 5 year-olds and 65% in 5 through 11 year-olds.
On February 10 this year, the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recommended immunization with Menactra vaccine for young adolescents at the pre-adolescent visit (11-12 year old), adolescents at high school entry (15 year old) and college freshmen living in dormitories. The committee recognized the need to reduce the threat of this potentially fatal bacterial infection among segments of the population found to be at increased risk of infection relative to the general population.
The supplemental license application is based upon three clinical studies. Two were randomized, multi-center, active-controlled, modified double-blind clinical studies of children aged 2 through 10 years comparing the safety and immunogenicity of Menactra vaccine to Menomune(R)-A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined), sanofi pasteur's currently-licensed polysaccharide meningococcal vaccine. The third was a Phase 2, controlled, multi-center, open-label study of children aged 3 through 5 years who had been vaccinated previously with Menactra vaccine approximately two years earlier. The objective of this study was to evaluate the antibody memory response to the vaccine.
Overall, data presented in the studies demonstrated that for children aged 2 through 10 years Menactra vaccine is safe and immunogenic. In addition, compared to Menomune vaccine, Menactra vaccine resulted in longer-term persistence of bactericidal antibody, improved production of high avidity antibody, and the establishment of immune memory. No clinically significant adverse events were identified after a 6-month controlled follow-up.
There are risks associated with all vaccines. In the studies, the immediate reactions were uncommon and consisted primarily of local redness at or near the injection site. They were reported for the most part as mild reactions and were reversible. Solicited systemic reactions were similar among the study groups and were described for the most part as mild, reversible, and of short duration. The most common complaints were irritability and drowsiness.
In general, the benefits of a successful conjugate vaccine include longer-lasting immune responses and boostable memory responses. Sanofi pasteur is the sole supplier of Menactra(TM) vaccine.
About Meningococcal Disease
Meningococcal disease is a rare but serious bacterial infection that strikes between 1,500 and 3,400 Americans every year, causing meningitis or sepsis in the majority of cases. Approximately 10 percent of individuals who contract meningococcal disease will die. Of those who survive, up to one in five suffer permanent disabilities such as hearing loss, neurological damage and limb amputations. Meningococcal disease often begins with symptoms that can be mistaken for common viral illnesses, such as the flu. However, unlike more common infections, meningococcal disease can progress very rapidly and kill an otherwise healthy young person in 48 hours or less.
About sanofi-aventis
The sanofi-aventis Group 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 950 million doses of vaccine in 2004, making it possible to protect more than 500 million people across the globe, which is about 1.4 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
Forward Looking Statement
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and 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" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis and Aventis, including those listed under "Forward-Looking Statements" and "Risk Factors" in sanofi-aventis's annual report on Form 20-F for the year ended December 31, 2003 and those listed under "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" in Aventis's annual report on Form 20-F for the year ended December 31, 2003. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Contact:
Michel Joly, Deputy Vice President, Communications and Vice President
Brand and Scientific Communication, Sanofi-aventis Tél :
+33-1-53-77-47-86 fax : +33-1-53-77-41-74; Len Lavenda Sanofi pasteur
U.S. Media Relations, Tél. : +1-570-839-4446,
Len.Lavenda@sanofipasteur.com, Beth Waters, Senior Vice President
Communications, Sanofi pasteur, Tél : + 33-4-37-37-73-99 Fax :
+33-4-37-37-79-76