Novartis vaccine Bexsero® sees high uptake in first large-scale public vaccination program to help protect against devastating meningitis B - Seite 2

Bexsero is the first broad coverage vaccine to help protect against meningitis B[8]. Since its launch in 2013, over half a million doses have been shipped worldwide[9]. Bexsero was also recently provided in the US to students at Princeton University and the University of California, Santa Barbara (UCSB) under a treatment Investigational New Drug (IND) designation from the US Food and Drug Administration (FDA) in response to local meningitis B outbreaks on both campuses[10],[11]. In June 2014, Novartis submitted a Biologic License Application (BLA) to the FDA for US marketing approval of Bexsero, which initiated a rolling submission process, following the receipt of a Breakthrough Therapy designation in April 2014.

Meningitis B is a rare but aggressive disease and is the leading cause of meningococcal disease and septicemia in the developed world[12],[13]. Meningitis B can kill or cause serious, life-long disabilities within 24 hours of symptom onset, leaving little time for intervention[12]. Vaccination is therefore the best defense against this devastating disease.

Meningococcal disease is most commonly caused by one of the five main serogroups of meningococcal bacteria (A, B, C, W-135 and Y)[14]. Prior to the development of Bexsero, vaccines were only available for four of these serogroups, and a vaccine to protect against serogroup B was the remaining piece needed to provide populations with broad-spectrum protection against all five serogroups, which together cause the majority of cases in the world[14],[15].

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "to offer," "growing," "will," "committed," "initiated," or similar terms, or by express or implied discussions regarding potential marketing approvals for Bexsero, or regarding potential future revenues from Bexsero. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Bexsero will be approved for sale in any market, or at any particular time. Nor can there be any guarantee that Bexsero will be commercially successful in the future. In particular, management's expectations regarding Bexsero could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.