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.
Thermo Fisher Scientific to acquire Clario Holdings, expanding clinical data capabilities
Hemogenyx Pharmaceuticals advances HG-CT-1 trial and opens paediatric recruitment
Rx to Go receives ACHC re-accreditation for pharmacy services
Shanton Pharma completes SAP-001 End-of-Phase 2 meeting with US FDA
Fibronostics completes Stone Clinical Laboratories acquisition
Syngene International to add GMP bioconjugation suite in Bengaluru
Eli Lilly's single-injection, once-monthly maintenance Omvoh regimen receives US FDA approval
4basebio synthetic DNA used in Phase I/II mRNA therapy trial