Policy & Regulation
Endo signs fill finish manufacturing and services agreement for Novavax COVID-19 vaccine candidate
28 September 2020 -

Pharmaceutical company Endo International plc (NASDAQ:ENDP) said on Friday that it has signed a non-exclusive agreement to provide fill-finish manufacturing services at its plant in Rochester, Michigan for the NVX-CoV2373 COVID-19 vaccine candidate from Novavax Inc.

The agreement has been executed between the company's subsidiary, Par Sterile Products LLC and Novavax Inc for NVX-CoV2373.

NVX–CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS–CoV–2, the virus that causes COVID-19 disease. NVX–CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains its patented saponin-based Matrix-M adjuvant to enhance and stimulate high levels of neutralizing antibodies.

In conjunction with the agreement, Par Sterile's Rochester facility has started production of Novavax's NVX-CoV2373 final drug product, with initial batches to be used in Novavax' pivotal Phase 3 clinical trial in the US. Par Sterile will fill-finish NVX-CoV2373 vaccine intended for commercial distribution in the US.

Currently, Novavax Inc's NVX-CoV2373 is in multiple Phase 2 clinical trials to evaluate the safety and immunogenicity of NVX-CoV2373 in the US 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. Interim data for these trials is expected before the end of 2020.

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