disease one year later.
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Disease rates declined among unvaccinated children as well as among those who were vaccinated, suggesting that the vaccine suppressed transmission of the infection in the unvaccinated population, thus offering the public health benefits of herd immunity. would require a vaccine that protects against multiple serogroups of meningococcal bacteria. Menactra vaccine contains three of these four serogroups, which cause approximately two thirds of meningococcal disease overall and 79 percent in the adolescent population. There is no vaccine against meningococcal disease caused by the B serogroup.
"With this third submission, we are on track to achieve our goal of submitting four new products for approval in 2003," said Igor Landau, Chairman of the Management Board of . "The various new products should complement our portfolio in key disease areas mainly diabetes, cancer and vaccines and are expected to substantially contribute to our growth in the coming years."
This submission of this novel vaccine by Pasteur, the vaccines business of , is the third new product submission by in 2003. In December, Genta and submitted to the FDA the targeted cancer therapy Genasense for fast track approval. is planning to submit the asthma medicine Alvesco, which is developed in co operation with Altana Pharma, to the FDA by the end of 2003.
Approval Of MenactraTM First Candidate Quadrivalent Conjugate Meningococcal Vacc
About Conjugate Vaccine Technology
Menactra vaccine is the first quadrivalent conjugate candidate for the prevention of meningococcal meningitis, considered the most deadly form of the three main types of meningitis. This vaccine is designed to offer protection against four serogroups of meningococcal disease (A, C, Y, W 135).
The regulatory submission is based on results of six pivotal studies, involving more than 7,500 clinical trial participants that received Menactra vaccine (also called MCV 4). The vaccine has shown an excellent safety and immunogenicity profile. site in Swiftwater, Pennsylvania, to produce Menactra meningococcal vaccine. Of survivors, up to one in five suffer long term permanent disabilities such as hearing loss, brain Ny Yankees Cap White damage, and limb amputations. Although the disease is most common in children under age four, in the 1990s, incidence increased substantially among 15 to 24 year olds, and one study found a 22.5 percent fatality rate among people in this age group who contracted meningococcal disease.
Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20 F of on file with the Securities and Exchange Commission and in the current Annual Report "Document de Reference" on file Adidas Hat Womens Black
with the "Commission des Operations de Bourse" in France, recently renamed "Autorite des marches financiers".
The current FDA licensed meningococcal disease vaccine, Menomune(R) A/C/Y/W 135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W 135 Combined), is made from a long chain of polysaccharides that come from the outer coat of the meningococcus bacterium, providing a limited duration of immunity. ran a national campaign to immunize 15 million children under age 17 with a conjugate vaccine that offered protection against one serogroup (the C serogroup) of meningococcal bacteria. The campaign resulted in an 85% overall decline in cases and 90% reduction in deaths from meningococcal serogroup C New Era Winnipeg Jets
"We are extremely pleased that our efforts to develop a conjugate vaccine for meningococcal disease have resulted in filing a BLA with the FDA," said Michel DeWilde, Executive Vice President, Research Development, Pasteur. "Conjugate vaccines have been shown to induce a better and longer lasting immune response than polysaccharide vaccines, we believe Menactra vaccine offers the potential for substantial control of bacterial meningitis."
Pasteur, the vaccines business of , in 2002, produced 1.4 billion doses of vaccine, making it possible to protect 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. is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, generated sales of euro 17.6 billion, invested euro 3.1 billion in research and development and employed approximately 71,000 people in its core business. corporate headquarters are in Strasbourg, France.
SWIFTWATER, Pa., Dec. Food and Drug Administration (FDA) for marketing approval of the use of Menactra(TM) Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine for protection against meningococcal meningitis in adolescents and adults aged 11 55 years. This will be the first electronic BLA filing for Pasteur.
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