Novartis sale of IL plant part of ‘strategic and opportunistic’ CGT biz

Novartis has offloaded the former AveXis gene therapy facility in Libertyville, Illinois to Bristol Myers Squibb to support its CAR-T portfolio.

Novartis added the Libertyville plant through the acquisition of AveXis in May 2018, and used it to support the commercial launch of one-time spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec).

But in November last year, the firm announced the plant was to be closed with 275 jobs at risk as part of a restructure that would consolidate Zolgensma production at its Durham, North Carolina facility.

DepositPhotos/benkrut

Step in Bristol Myers Squibb, which this week announced it is taking over the facility from Novartis to add inhouse viral vector capabilities to support its growing cell therapy business. The firm has two commercial chimeric antigen receptor (CAR) T-cell therapies: Abecma (ide-cel) and Breyanzi (liso-cel).

“The addition of an inhouse facility for viral vector production that complements our external partnerships affords us the ability to manufacture current and next-generation vector technology, and increase future capacity,” said Karin Shanahan, executive vice president, Global Product Development & Supply, Bristol Myers Squibb.

“Bringing the Libertyville site operations and employees onboard to join our expanding global cell therapy manufacturing network enhances the depth and breadth of our existing capabilities.”

For Novartis, the deal – of which financials have not been divulged – represents the latest adjustment in its cell and gene therapy (CGT) manufacturing network, following the sale of another plant earmarked for Zolgensma production in Longmont, Colorado, sold to contract development and manufacturing organization (CDMO) AGC Biologics in July 2021.

Meanwhile, the Swiss pharma giant has been leveraging its CGT network within its Global Biotech Cooperations (GBTC) third-party manufacturing business, announcing a deal to make a cell therapy for Carisma Therapeutics and, more recently, to supply Johnson & Johnson (J&J) and Legend Biotech with their commercialized CAR-T Carvykti (ciltacel).

“When you look at our investments over the last five years in advanced therapy platforms, we built up quite a bit of know-how. We believe we’re one of the largest producers of AAV gene therapies in the world one of the largest producers of CAR therapies using lentiviral technologies in the world through the pandemic,” Novartis CEO Vas Narasimhan said during his firm’s first quarter results call this week.

As such, “the opportunity exists when appropriate competitively to leverage that manufacturing base to generate a high-margin business for the company,” he added.

CFO Harry Kirsch described the joint inhouse and CDMO model as “a mix of strategic and opportunistic” for both the CGT side and its wider biologics business.

“Of course, in terms of priority first is the Innovative Medicine strategy as well as the Sandoz biosimilars,” he said. “If there’s capacity available, again, with contractual obligations, we will leverage it further. […It’s] very important in terms of further maximizing our capacity as well as nice delivery to the bottom-line.”