Novavax chooses Paragon for vaccine CDMO services

Manufacturing equipment and related assets will be sold to Catalent’s Paragon Gene Therapy for $18 million in cash

Catalent Biologics’ Paragon Gene Therapy unit has announced it will assume the leases to two Novavax product development and manufacturing facilities. This will give the CDMO immediate access to state-of-the-art manufacturing equipment, people and space to accelerate the growth of its gene therapy business.

Novavax is a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases. This arrangement significantly reduces Novavax’ operating costs and provides a cash payment at closing of approximately US$18 million.

This cost savings and cash infusion allow Novavax to focus on advancing its NanoFlu and ResVax through the next phases of clinical development and regulatory review.

Under the terms of the agreement, Paragon will purchase from Novavax all of the related manufacturing equipment and facility assets; in addition, over 100 of Novavax’ highly qualified manufacturing and quality employees will transfer to Paragon.

Concurrently, Novavax will be entering into a long-term arrangement with Paragon to provide process development and manufacturing services for specified Novavax programs. The transactions are expected to close in July this year.

“This alliance is a true win-win-win for Paragon, Novavax and our employees,” said Stanley C Erck, President and CEO of Novavax.

Most Novavax employees at the two sites will transfer to Paragon and will continue to provide process and analytical development and, potentially, manufacture GMP materials for Novavax’ clinical trial supplies for NanoFlu and ResVax, among other new projects.

These employees will also provide continuity and support of Novavax’ biologics license applications and post-licensure activities. Over the longer term, Paragon will be available to manufacture commercial quantities of the vaccines for Novavax.

Erck added: “This transaction allows Novavax to focus on discovery, clinical work, regulatory licensure and commercialisation of innovative vaccines that may improve on existing approaches to prevent serious infectious diseases.”

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