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As phase 3 kicks off, Novavax and Endo ink manufacturing pact for COVID-19 vaccine

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Maryland biotech Novavax has kicked off late-stage testing for its COVID-19 shot in the U.K. as the hunt for a vaccine hits critical mass—and its U.S. and India trials aren’t far behind. To help supply those pivotal trials and a potential commercial rollout, Novavax is partnering with a major generics player.

Endo’s Par generics unit will handle phase 3 clinical supply and commercial fill-finish responsibilities for Novavax’s recombinant COVID-19 vaccine, NVX-CoV2373, at its Rochester, Michigan, plant, the partners said Friday.

As part of the deal, Endo will produce bulk batches of Novavax’s candidate for a pivotal late-stage clinical trial and then handle commercial finishing duties if the vaccine gets approved. The biotech said Thursday that NVX-CoV2373 has officially moved into phase 3. 

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In a statement, Endo CEO Blaise Coleman said the Par’s Rochester facility had a “long history” of producing sterile injectables and vaccines. 

As one of the most promising contestants in the race for a COVID-19 vaccine, Maryland-based Novavax has been working to rapidly scale its manufacturing capacity to meet what would likely be global demand if its shot passes regulatory muster. 

RELATED: Novavax adds antigens to COVID-19 production pact with Indian vaccines giant

Earlier this month, Novavax and vaccines giant Serum Institute of India (SII) fleshed out an earlier manufacturing pact to include production of the antigen used in the shot.

SII will join five other manufacturers helping to produce the antigen component of NVX-CoV2373, while aiming to produce 1 billion doses of the shot specifically for low- and middle-income countries starting in mid-2021, Novavax said.

All told, Novavax’s growing supply chain will enable it to produce up to 2 billion doses per year of NVX-CoV2373, once manufacturing fires up to full speed in the middle of next year. The biotech has a range of supply deals in the U.S. and abroad, including an in-the-works pact with the EU.

RELATED: Endo replaces CEO, appoints M&A specialist to board in possible push for deals

Meanwhile, the Novavax agreement marks Endo’s first major foray into the COVID-19 response months after the struggling drugmaker replaced its erstwhile CEO.

Coleman, Endo’s former chief financial officer, replaced CEO Paul Campanelli in February in a transition announced back in November. Endo also added Mark Barberio, of business and M&A consulting firm Markapital, to its board of directors. Barbiero previously worked as co-CEO and CFO for Mark IV, a global manufacturing firm.

Campanelli’s suprise departure caught some analysts off guard, particularly because he had renewed his CEO contract only months before he announced he would be leaving, and Endo still faces a multibillion-dollar opioid legal overhang.

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