Vaxchora™ also granted priority review status by FDA as a vaccine candidate addressing a tropical disease
REDWOOD CITY, Calif. – December 16, 2015 – PaxVax Inc., a fully integrated specialty vaccine company committed to developing and commercializing innovative vaccines against infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics License Application (BLA) for its affiliate PaxVax Bermuda Ltd.’s single-dose oral cholera vaccine Vaxchora™. PaxVax also announced today that the FDA has granted Vaxchora priority review status. If licensed, Vaxchora would be the only vaccine in the U.S. against cholera and PaxVax’s second FDA-licensed vaccine after Vivotif® (typhoid fever vaccine).
“Travelers residing in the U.S. currently have very few options to protect themselves against cholera when going abroad, and we are pleased with the progress we are making in bringing an effective single-dose cholera vaccine to the U.S. market,” said Nima Farzan, Chief Executive Officer of PaxVax, Inc. “We are also pleased to announce that Vaxchora has been granted priority review status, a critical step in the process of being awarded a Priority Review Voucher. The potential of being granted a voucher has been an important incentive for PaxVax and our decision to bring this vaccine to the U.S. market.”
The BLA, which was submitted on October 16, 2015, is based on successful results from a 10 and 90-day cholera challenge trial, as well as two other safety and immunogenicity trials in healthy adults. More than 3,000 participants were enrolled in the Phase 3 trials that evaluated Vaxchora at sites in Australia and the United States. Vaxchora also successfully met the Phase 3 primary endpoints and demonstrated efficacy in an immunogenicity study of older adults 46 to 64 years of age. The FDA’s action date for the Vaxchora BLA is June 15, 2016.
The cholera strain used in Vaxchora is CVD 103-HgR, which was in-licensed from the University of Maryland School of Medicine’s Center for Vaccine Development in 2010. If approved, Vaxchora will be commercialized through the existing PaxVax marketing and sales infrastructure, which currently commercializes Vivotif.
Cholera is an acute intestinal diarrheal infection caused by toxigenic Vibrio cholerae bacteria generally acquired by ingesting contaminated water or food. According to the World Health Organization, the global disease burden is estimated to be three to five million cases and 100,000 to 120,000 deaths per year. Cholera often manifests as explosive epidemics that rapidly move through populations, such as the recent outbreak in Iraq and those that occurred in Peru and Haiti in 1991 and 2010, respectively. The FDA has identified Cholera as one of the eligible neglected tropical diseases under its Priority Review Voucher program.
Founded in 2007, PaxVax is a fully integrated specialty vaccine company with a mission to develop, manufacture and commercialize innovative vaccines against infectious diseases in a socially responsible manner. By focusing on diseases where there is unmet need and committing to socially responsible operations, PaxVax has been able to successfully address the compelling, overlooked traveler market with commercial and late-stage vaccine candidates. The PaxVax portfolio includes a licensed vaccine for typhoid (Vivotif®), and vaccines at various stages of research and clinical development for cholera, anthrax, HIV, and hepatitis A. PaxVax is headquartered in Redwood City, California and maintains research and development and Good Manufacturing Practice (GMP) facilities in San Diego, California, USA, and Bern, Switzerland. More information is available at www.PaxVax.com.