Policy & Regulation
Endo Inks Fill-Finish Manufacturing and Services Agreement for Novavax COVID-19 Vaccine Candidate
25 September 2020 - - Dublin-based specialty pharmaceutical company Endo International plc's (NASDAQ: ENDP) Par Sterile Products, LLC (Par Sterile) subsidiary has entered into a non-exclusive agreement with US-based biotechnology company Novavax, Inc. to provide fill-finish manufacturing services at its plant in Rochester, Michigan for NVX-CoV2373, Novavax' COVID-19 vaccine candidate, the company said.

Under the terms of the agreement, Par Sterile's Rochester facility has begun 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 will also fill-finish NVX-CoV2373 vaccine intended for commercial distribution in the United States. Financial and other terms of the agreement were not disclosed.

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. Interim data for these trials is expected before the end of 2020.

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 Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

In preclinical trials, NVX–CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection.

In its Phase 1 portion of the Phase 1/2 clinical trial, NVX–CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. 

Novavax has secured USD 2bn in funding for its global coronavirus vaccine program, including up to USD 388m in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

Novavax, Inc. (NASDAQ: NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. 

Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults.

Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. 

Endo International plc (NASDAQ: ENDP) is a specialty pharmaceutical company.
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