Novartis has acquired a biomanufacturing facility – earmarked for closure by AstraZeneca – ahead of the potential launch of AveXis’ gene therapy for spinal muscular atrophy, Zolgensma.
Since Novartis bought AveXis for $8.7 billion (€7 billion) in May 2018, the Swiss pharma giant has rapidly grown its gene therapy manufacturing network.
The latest action sees the firm add the 700,000 square-foot Longmont facility to its AveXis operations in what it says is preparation for the launch of Zolgensma (onasemnogene abeparvovec-xioi1), its gene for the treatment of spinal muscular atrophy (SMA) Type 1 currently under regulatory review. The US Food and Drug Administration has issued a PDUFA date for next month.
The acquisition follows two investments totaling $115 million by Novartis to establish a gene therapy manufacturing center in Durham, North Carolina to support AveXis’ gene therapy pipeline targeting rare neurological genetic diseases. The firm also has manufacturing capacity in Illinois and is expanding product development at a facility in San Diego, California.
“AveXis has now established leading technical manufacturing capabilities with the capacity to deliver our robust pipeline, as well as the flexibility to enter into multiple external partnerships as the development and manufacturing partner of choice in gene therapy,” a spokesperson for the firm told Bioprocess Insider.
“At the outset, production will focus on Zolgensma, our investigational gene therapy awaiting global regulatory approvals for treatment of SMA Type 1. The production capacity added at Longmont gives us the flexibility to shift to other products as those are commercialized by AveXis and/or partners.”
AveXis, AZ and Amgen
Novartis acquired the plant from AstraZeneca for an undisclosed fee.
Earlier this year, AstraZeneca announced plans to shutter the Longmont facility, along with its nearby Boulder facility, as part of a biomanufacturing consolidation strategy.
“AstraZeneca has made the decision to consolidate the biologics manufacturing network in one large-scale drug substance facility – our site currently operating in Frederick, Maryland,” the Anglo-Swedish Big Pharma firm told this publication at the time.
The AveXis spokesperson told us the firm “plans to offer positions to all of the approximately 150 employees previously employed at the biologics manufacturing site, and to announce further expansion of new jobs in the near term.
“Having access to the highly skilled and experienced talent pool in Longmont made this location especially attractive.”
Prior to AstraZeneca, Amgen owned the facility (and the Boulder plant) and used it support drug substance manufacturing for its blockbuster biologics Epogen (Epoetin) alfa and Aranesp (darbepoetin alfa).