Endo Agrees to Provide Fill-Finish Manufacturing for Novavax COVID-19 Vaccine
Endo International’s subsidiary, Par Sterile Products, LLC, has agreed to provide fill-finish manufacturing services to Novavax for commercial distribution of the vaccine company’s nanoparticle COVID-19 vaccine candidate NVX-CoV2373. Par Sterile’s Rochester, Michigan, facility has also started production of NVX-CoV2373 final drug product, which will be used in pivotal Phase III clinical trials in the United States.
"We are very pleased to help bring Novavax' COVID-19 vaccine to the public," Endo president and CEO Blaise Coleman said in a statement. "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."
Novavax’s president and CEO Stanley C. Erck said in a statement that the agreement with Endo represents “an important piece” in the finalization of Novavax’s supply chain for the U.S. clinical trial and as well as for commercial distribution of their nanoparticle vaccine candidate.
"Endo's partnership and expertise are enabling rapid delivery of the vaccine for pivotal clinical testing, which we expect to get underway very soon," Erck said.
In August 2020, both the U.S. and Australia initiated Phase II clinical trials to investigate the immunogenicity and safety of NVX-CoV2373. These trials build on positive Phase I findings which showed that NVX-CoV2373 produced IgG antibodies in healthy patients after a single dose, and all participants developed wild-type virus neutralizing antibody responses after a second dose.
The Phase II trial expands the cohort to include older adults, a demographic particularly vulnerable to the effects of COVID-19. South Africa also began a Phase IIb study in August to evaluate the efficacy of the vaccine candidate. Novavax expects interim data from these trials to be available before the end of this year.
The United Kingdom also recently initiated a Phase III study of Novavax’s COVID-19 vaccine candidate as part of an agreement between the company and the U.K. government. The terms of the agreement state that Novavax will provide the United Kingdom with 60 million doses of the vaccine should regulators provide approval. The United Kingdom is the first country to study NVX-CoV2373 in the context of a Phase III trial. Up to 10,00 patients between 18 to 84 years of age are expected to enroll, and at least 25% of the participants will be over the age of 65. Some patients with comorbidities and pre-existing conditions that make them susceptible to worse COVID-19-related outcomes, such as hypertension and diabetes, are also expected to be enrolled.
“We are honored to partner with the U.K. government to deliver a vaccine that could provide vital protection in the fight against the global health crisis,” said Erck in a statement. “Our Phase III clinical trial in the U.K. will be a critical component to assess the efficacy of NVX-CoV2373, which in a Phase I trial has already demonstrated to be generally well-tolerated and to elicit robust antibody responses. We are also delighted to expand our collaboration with FUJIFILM Diosynth Biotechnologies to manufacture our antigen at its UK site.”
The news of these agreements follows Novavax’s expansion of its collaboration with FUJIFILM Diosynth Biotechnologies earlier this summer. Under the terms of this collaboration, FUJIFILM will develop the antigen component of Novavax’s COVID-19 vaccine at its Billingham, Stockton-on-Tees site in the U.K. This U.K. site is expected to manufacture approximately 180 million doses of the vaccine each year. Additional manufacturing sites are located in North Carolina and Texas.