Pfizer's Two Stage Three Results on TRUMENBA Meet All Endpoints

Pfizer Inc.

disclosed the results of two stage 3 trials demonstrating the immunogenicity of TRUMENBA (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe. According to the company, the two studies, one in adolescents and other in young adults, met all primary immunogenicity endpoints. Pfizer said that the secondary data presented indicated that TRUMENBA exhibited similar immune responses against ten additional MnB strains in both young adults and adolescents. The company added that the data continued to support the vaccine's current safety, as well as, tolerability profile. The pharmaceutical firm indicated that the results were presented at the 34th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID 2016). The company's SVP and Head of Vacine R&D, Kathrin Jansen, said that "TRUMENBA is designed to provide protection against serogroup B meningococcal disease. The Phase 3 data show that TRUMENBA elicits an immune response that is effective against prevalent meningococcal serogroup B strains in the U.S. and Europe, as well as 10 additional strains of this unpredictable disease. These data support the expectation that vaccination with TRUMENBA will help prevent this uncommon, but devastating disease in adolescents and young adults." Currently, TRUMENBA is approved in the America. Pfizer said that TRUMENBA was indicated for active immunization to avoid invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age. The company added that the approval of the drug was based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains was not confirmed. Shares of the company gained 0.15% on Thursday.