Benzinga | Sep 25, 2020 07:01AM EDT

Endo Announces Fill-Finish Manufacturing And Services Agreement For Novavax COVID-19 Vaccine Candidate

DUBLIN, Sept. 25, 2020 /PRNewswire/ -- Endo International plc (NASDAQ:ENDP) today announced that its subsidiary, Par Sterile Products, LLC (Par Sterile) 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.

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.

"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(tm)," 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 2 clinical trials. A Phase 2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August 2020 inthe United StatesandAustralia building on positive Phase 1 results and expanding to include older adults. A Phase 2b clinical trial to assess efficacy began inSouth Africain August 2020. Interim data for these trials is expected before the end of 2020.