Through the acquisition, PaxVax assumes manufacturing, sales, regulatory and distribution responsibilities related to the global supply of Vivotif including approximately 80 employees worldwide. Vivotif is a live attenuated typhoid fever vaccine for oral administration.
“The manufacturing and sales channel for Vivotif is highly complementary to those for our cholera vaccine candidate, currently finishing Phase 3 clinical trials, and the site and production assets we are acquiring lay a strong foundation for further growth,” said PaxVax CEO Kenneth Kelley. California-based PaxVax also runs another GMP facility in San Diego, California.
Additionally, PaxVax is acquiring marketing, sales and distribution capabilities in select markets including the US, and certain other assets related to travel vaccines such as hepatitis A.
“We are delighted to welcome our new Swiss colleagues and a site with such long standing heritage in vaccines to the PaxVax team. Their work will be central to helping us build and commercialize a world-class portfolio of specialty vaccines,” Kelley said.
Vivotif was approved by the US FDA in 1989 and is currently approved for sale in 27 countries.
In addition to Vivotif, PaxVax is developing a vaccine candidate for cholera, PXVX0200, which is nearing completion of its Phase III clinical trials and was granted FDA fast track designation as there is no vaccine available in the US against cholera. PaxVax also intends to develop a hepatitis A vaccine for travelers and has a pipeline of early-stage travel vaccine candidates for dengue, malaria and rabies, as well as vaccines to treat anthrax, HIV, and H5N1 (pandemic bird flu).
PaxVax also announced that it has closed up to $50m in secured debt financing from an investment fund managed by Pharmakon Advisors and $12m in an extension on its Series B preferred stock.
In addition to the debt financing, the funds will be used for the acquisition of Vivotif.
Additional proceeds from this financing will be used to support clinical development, regulatory review and the expected global launch of PaxVax’s cholera vaccine candidate, PXVX0200, currently in Phase 3 clinical testing.
“PaxVax has emerged as an exciting new player in the global travel vaccine market,” said Martin Friedman, Managing Member of Pharmakon Advisors. “We are pleased to be partnering with PaxVax in support of their efforts to build a world-class vaccine company.”
To date, PaxVax has raised $80 million from equity investors including Ignition Ventures, Ignition Growth Capital and the Blue Haven Initiative. The company is also supported by grants, contracts, and awards from the NIH through the National Institute of Allergy and Infectious Diseases (NIAID), its Division of Acquired Immunodeficiency Syndrome (DAIDS) and its Division of Microbiology and Infectious Diseases (DMID), as well as the Wellcome Trust and the Bill and Melinda Gates Foundation.
“This financing strengthens PaxVax’s capital position as we commence commercial operations with our acquisition of Vivotif and prepare for the anticipated regulatory approval of our cholera vaccine candidate next year,” Kelley added. “We look forward to working with Pharmakon, and all our investors, as we continue to execute on our strategy to build the world’s leading specialty vaccine company.”