FDA Accepts PaxVax's IND for Single-Dose Oral Cholera Vaccine

MENLO PARK, Calif., Mar 19, 2012--PaxVax Corporation, developer of innovative and socially responsible oral vaccines against infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for its single-dose oral cholera vaccine, clearing the way to begin clinical trials. The company intends to begin Phase 3 trials later this year.

Cholera is an acute intestinal infection caused by toxigenic Vibrio cholerae bacterium. Cholera infections are most commonly acquired from ingesting contaminated water or food. Infection causes severe watery diarrhea and even death if not treated promptly. According to the World Health Organization, the global disease burden is estimated to be 3--5 million cases and 100,000--130,000 deaths per year.

PXVX-0200, is a single dose, oral, live, attenuated vaccine against cholera, which was previously approved and marketed in six countries under the brand name "Orochol." Unlike currently available cholera vaccines requiring two doses over the course of weeks before effectiveness, this vaccine's rapid onset of protection in as little as seven days after a single administration makes it ideal for people preparing to travel to areas where cholera is endemic or where it has recently caused an epidemic.

"We expect our cholera vaccine will be the first vaccine for cholera available in the United States, and the only one-dose oral vaccine in the world," said Kenneth Kelley, Chief Executive Officer of PaxVax. "Further, given that cholera is classified as a neglected tropical disease by the FDA, this product should qualify us for a priority review voucher."

The company has partnered with SynCo Bio Partners B.V., a biopharmaceutical GMP Contract Manufacturing Organization with specific expertise in live microbial biotherapeutics located in Amsterdam, The Netherlands, to manufacture the initial material for the cholera vaccine for clinical trials.

Myron M. Levine M.D., Director of the Center for Vaccine Development at the University of Maryland School of Medicine and Albert B. Sabin Gold Medal winner, co-inventor of the vaccine now licensed to PaxVax, and a member of the company's Scientific Advisory Board, commented: "I applaud PaxVax for taking the lead to bring this vaccine back to market. I believe that the practicality of a single-dose oral vaccine will make vaccination logistically simpler and more practical, thereby offering for the future a better tool to control cholera in explosive outbreak situations."

PaxVax has raised more than $50 million from investors including Ignition Partners and the Wellcome Trust, and is supported by grants from the U.S. National Institutes of Health (NIH) through the National Institute of Allergy and Infectious Diseases (NIAID) and its Division of Acquired Immunodeficiency Syndrome (DAIDS), as well as the Bill and Melinda Gates Foundation. More information is available at www.paxvax.com .

About PaxVax

PaxVax is a privately held company established in 2007 to develop and commercialize innovative and socially responsible vaccines against infectious diseases. PaxVax has a clinical-stage product portfolio, including a cholera vaccine entering Phase 3 and a pandemic H5N1 influenza vaccine entering Phase 2. The company also has vaccines in development for HIV and anthrax under R&D contracts with NIH. The company's proprietary adenoviral-based technology platform enables the rapid development of oral vaccines that can target any viral or bacterial protein antigen. The company's vaccine candidates are designed to be easier to manufacture, store, distribute, administer and deliver across the globe than conventional injectable vaccines while enhancing the desired immune response to the vaccine antigens. The company's offices are headquartered in Menlo Park, Calif., and the R&D laboratories and licensed GMP production facility are based in San Diego, Calif.