BLA submitted for approval of Menactra.

2004 JAN 21 - (NewsRx.com & NewsRx.net) -- Aventis (AVE) announced the submission of a Biologics Licensing Application (BLA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the use of Menactra 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 Aventis Pasteur.

A submission for ages 2-55 is planned for 2004 in Europe and submissions for groups below 11 years of age will follow in the U.S.

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).

This submission of this novel vaccine by Aventis Pasteur, the vaccines business of Aventis, is the third new product submission by Aventis in 2003. In June, the fast-acting insulin Apidra was submitted for approval in the EU and the U.S. In December, Genta and Aventis submitted to the FDA the targeted cancer therapy Genasense for fast-track approval. Aventis 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.

"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 Aventis. "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."

"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 VP, research & development, Aventis 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."