Endo International’s subsidiary, Par Sterile Products, LLC has entered into a non-exclusive agreement with Novavax, Inc. to provide fill-finish manufacturing services at its plant in Rochester, MI for Novavax' COVID-19 vaccine candidate, NVX-CoV2373.
Par Sterile's Rochester facility has begun production of NVX-CoV2373 final drug product, with initial batches to be used in Novavax' pivotal Phase III trial in the U.S. Par Sterile will also fill-finish NVX-CoV2373 vaccine intended for commercial distribution in the U.S. Financial and other terms were not disclosed.
"This agreement puts an important piece in place as we finalize our supply chain for the U.S. clinical trial and eventually, commercial distribution of NVX-CoV2373, our nanoparticle vaccine adjuvanted with Matrix-M™," said Stanley C. Erck, President and CEO, Novavax. "Endo's partnership and expertise are enabling rapid delivery of the vaccine for pivotal clinical testing, which we expect to get underway very soon."
"We are very pleased to help bring Novavax' COVID-19 vaccine to the public," said Blaise Coleman, President and CEO of Endo. "Our Rochester, Michigan facility has a long history of manufacturing critical vaccines and sterile injectable products for the U.S. market and we are proud to partner with Novavax on such a critical initiative. This partnership further underscores Endo's commitment to helping everyone we serve live their best life through the delivery of life-enhancing therapies."
NVX-CoV2373 is currently in multiple Phase II trials evaluating the safety and immunogenicity, which began in August 2020 in the U.S. and Australia.
