Catalent Novavax deal ups Paragon gene therapy footprint by 65%

The $18 million acquisition is a drop in the ocean compared to the Paragon Bioservices buy but demonstrates Catalent’s appetite to push ahead in the gene therapy space.

The $18 million (€16 million) deal sees contract development and manufacturing organization (CDMO) Catalent – through its gene therapy unit Paragon – take over the leases of two facilities in Rockville and Gaithersburg, Maryland from vaccine firm Novavax. All related manufacturing equipment and over 100 of Novavax’ employees will transfer to Paragon.

“Paragon will acquire approximately 14,000 square feet of additional manufacturing capacity and over 22,000 square feet of laboratory space to be used for process, analytical and formulation development,” Thomas VanCott, chief technology and strategy officer at Paragon Gene Therapy, Catalent Biologics, told Bioprocess Insider.

One of the two sites Catalent will take over in Maryland. Image:GoogleStreetview

“This increases Paragon’s lab/manufacturing footprint by 65% over what exists at the University of Maryland Biopark today.” The deal also provides over 68,000 square feet of administrative space, which he said could be converted into laboratory and/or manufacturing space as needs arise in the future.

A ‘win-win’ for Paragon and Novavax

Along with an expanded manufacturing space, the agreement gives Paragon access to a team of staff experienced with viral vectors, Virus-like particles (VLPs) and the Novavax’ SF9 insect cell baculovirus system.

“Additionally, the Novavax team will provide deep expertise in late-stage analytical and process development (i.e., assay validation and process characterization) as well as a strong expertise in formulation development, a strategic new service offering that we feel will be of high value to our customers as they progress to late-stage development.”

Under terms of the deal, Paragon will also take charge of development and manufacturing activities for Novavax programs, including seasonal influenza vaccine candidate NanoFlu. NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle vaccine made using the SF9 insect cell baculovirus system.

Novavax CEO Stanley Erck described the deal as “a true win-win-win for Paragon, Novavax and our employees,” adding the alliance will bring Novavax a “strategic and cost-effective approach to addressing its manufacturing needs into the future.”

Motivated by Paragon

For Catalent, the deal brings further growth in a sector it only entered in April through its $1.2 billion acquisition of Paragon Bioservices.

According to Jefferies analyst David Windley, “Novavax is motivated by Paragon” as Paragon had been pursuing such a deal prior to its takeover by Catalent to cope with the high demand for gene therapy services.

“These facilities lengthen the gene therapy clinical growth path,” he wrote in a note. “Paragon’s Biopark [in Anne Arundel County, Maryland] can handle $140 million, but is already >$100 million and has grown 100% per year. We thought the absence of a Biopark expansion plan seemed a little odd with it maxing out in the next ~18 months. Now we know why.”

VanCott did not confirm how long Paragon had been in talks with Novavax for but said the firm “has been acquainted with Novavax for many years having similar expertise in the manufacturing of virus-based products and both being located in Maryland Biotechnology hubs.

“Due to Paragon’s expanding pipeline and client interest in its services, the company has been evaluating expansion opportunities in the area for the past couple of years.”

Continued growth

Meanwhile, Catalent announced in April separate plans to support Paragon’s client Sarepta Therapeutics through a second dedicated manufacturing facility close to Baltimore-Washington International Airport.

Moreover, the announcement comes just days after Catalent struck a deal to grow its biologics capacity through the acquisition of an Italian fill & finish facility from Bristol-Myers Squibb.

As such, we asked VanCott if any more acquisitions or expansions are in the pipeline for Catalent Biologics.

“Catalent is always evaluating new opportunities, both facility expansions and/or adopting novel platforms. This includes evaluating those which will enrich our gene therapy service offerings, thereby retaining our leadership position in the field and offering world class gene therapy manufacturing services to our clients.”