SynCo Bio Partners, a contract manufacturer of biopharmaceuticals, has announced that one of its customers, PaxVax, has received FDA approval for Vaxchora™, a single-dose oral, live attenuated cholera vaccine, indicated for use in adults 18 to 64 years of age. Vaxchora is the only vaccine available in the U.S. for protection against cholera and the only single-dose vaccine for cholera currently licensed anywhere in the world. The bulk drug substance for Vaxchora is manufactured at SynCo Bio Partners' Amsterdam facility.
SynCo Bio Partners has supported PaxVax with the clinical development program of Vaxchora, including Phase III clinical bulk drug manufacture and supply, process validation, FDA pre-approval inspection for product registration and manufacture of pre-commercial supply.
Pierre Warffemius, CEO of SynCo Bio Partners comments: "For both companies, it is a defining moment that PaxVax has received FDA approval for Vaxchora. The approval is the outcome of excellent teamwork, mutual sense of responsiblity and a strong emphasis on quality, demonstrating the value of a long term commitment between the two companies. We look forward to continuing our support to PaxVax, by ensuring safe, compliant and cost effective manufacturing of the commercial Vaxchora vaccine."
"Cholera is an underestimated disease that is found in many popular global travel destinations and we are proud to provide the only licensed vaccine in the United States against this potentially deadly pathogen" said Nima Farzan, CEO and President of PaxVax. "Achieving FDA approval is an important milestone for PaxVax and a testament to our unwavering commitment to producing vaccines of the highest quality. SynCo shares this commitment and has been an important partner in bringing Vaxchora to market."