Novartis Bexsero® vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US

Novartis International AG / Novartis Bexsero® vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• With today's approval, Bexsero is now licensed in 37 countries; since first approval in Europe, over 1 million doses have been distributed worldwide

• Bexsero's two-dose regimen offers a flexible dosing schedule, with the first and second doses administered at least one month apart[1]

• Access to meningitis B vaccines for all adolescents and young adults will be critical to help prevent this potentially deadly and unpredictable disease[2],[3]

Basel, January 23, 2015 - Novartis announced today that the US Food and Drug Administration (FDA) has granted accelerated approval of Bexsero^® (Meningococcal Group B Vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by serogroup B (also known as meningitis B) in adolescents and young adults from 10 years through 25 years of age. Bexsero is the only meningitis B vaccine approved in the US with a two-dose regimen and a flexible dosing schedule^[1]. As part of the accelerated approval process, Novartis will complete its ongoing studies to confirm the effectiveness of Bexsero against diverse serogroup B strains.

"While rare, meningitis B is a devastating disease that can hit anyone anytime, especially teenagers and children," said Andrin Oswald, Division Head, Novartis Vaccines. "This approval is an important milestone towards our goal of helping to prevent any further loss of life."

In Phase II and Phase III studies, Bexsero demonstrated a protective immune response in adolescents and young adults after two doses. Bexsero also offers a flexible dosing schedule, with the first and second doses administered at least one month apart[1].

"As someone who contracted meningitis during college, I am hopeful that young adults across the country will soon have routine access to meningitis B vaccines," said Jamie Schanbaum, 25-year-old founder of the meningitis advocacy organization The J.A.M.I.E. Group. "There is no reason that young people in the US should be in danger of a vaccine-preventable disease as devastating as meningitis."

The tolerability profile of Bexsero was also demonstrated as part of a US Centers for Disease Control and Prevention (CDC)-sponsored clinical trial conducted in more than 15,000 individuals at Princeton University and the University of California, Santa Barbara (UCSB) during meningitis B outbreaks on these college campuses. The safety data from the CDC clinical trial are consistent with results observed in previous studies[1],[4].