Endo Int'l To Provide Fill-finish Manufacturing Services For Novavax' COVID-19 Vaccine Candidate

(RTTNews) - Endo International plc (ENDP), on Friday, said its 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, Michigan for NVX-CoV2373, Novavax' COVID-19 vaccine candidate. Financial and other terms of the agreement remain undisclosed.

As per the deal, Par Sterile's Rochester facility has commenced production of NVX-CoV2373 final drug product, with initial batches to be used in Novavax' pivotal Phase 3 clinical trial in the United States. Par Sterile would also fill-finish NVX-CoV2373 vaccine intended for commercial distribution in the United States.

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease.

NVX-CoV2373 is currently in multiple Phase 2 clinical trials. A Phase 2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August 2020 in the United States and Australia building on positive Phase 1 results and expanding to include older adults. A Phase 2b clinical trial to assess efficacy began in South Africa in August 2020.

The company expects interim data for these trials to be availale before the end of 2020.