Novartis subsidiary AveXis plans to expand its gene therapy manufacturing capacity by agreeing to purchase AstraZeneca’s advanced biologics therapy manufacturing campus in Longmont, CO, for an undisclosed price.
AstraZeneca in January disclosed plans to close the Longmont facility, as well as another Colorado manufacturing site in Boulder, and lay off all 210 employees at both campuses, through a Worker Readjustment and Retraining Notification Act (WARN) 60-day notice posted on a state website.
Instead, AveXis said yesterday, it plans to offer positions to all approximately 150 staffers previously employed in Longmont, and will announce plans “in the near term” to hire more employees there.
AveXis cited its plans to launch the gene therapy candidate Zolgensma® (onasemnogene abeparvovec-xioi), formerly AVXS-101, which is awaiting global regulatory approvals for the treatment of spinal muscular atrophy (SMA) Type 1. The FDA has set a Prescription Drug User Fee Act (PDUFA) target decision timeframe of May 2019.
AveXis also cited the need to manufacture future gene therapy treatments now in development.
Novartis acquired AveXis for $8.7 billion last year, with the aim of bolstering both its presence in gene therapy and its neuroscience portfolio.
The six-building Longmont campus consists of nearly 700,000 square feet of space designed for biologic drug manufacturing as well as for offices, laboratories, warehousing, and utilities. AstraZeneca bought the site for an undisclosed price from Amgen in 2016.
AveXis said its initial start-up activities in Longmont will include preparing the facility for scaling, manufacturing and testing of gene therapies and hiring staff.
Longmont, CO, would become AveXis’ fourth manufacturing facility. The company operates a manufacturing facility in Bannockburn, IL, and is constructing additional space at its facility in Durham County, NC, that is set to be operational in 2020. AveXis is also expanding its product development capacity at its San Diego facility.
‘A Crucial Role’
“Our Longmont, Colorado, campus, along with our existing manufacturing sites in Illinois, California and North Carolina, will play a crucial role in helping us achieve the future manufacturing capacity required to meet the global patient need for novel gene therapies,” Andrew Knudten, AveXis’ Senior Vice President, Global Strategic Operations, said in a statement. “We are eager to add the talented team in Longmont to AveXis, and we hope that they will choose to join us as we build world-leading manufacturing capabilities in gene therapy.”
Added AveXis President Dave Lennon: “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.”
“With the opening of our fourth location in the US, we will create more than 1,000 high-tech biologics manufacturing jobs by the end of 2019,” Lennon added.
The other jobs will be created in Durham County, where AveXis on February 18 announced plans to carry out a $60 million expansion of its manufacturing center in return for state and local economic development incentives.
“We are eager to add the talented team in Longmont to AveXis, and we hope that they will choose to join us as we build world-leading manufacturing capabilities in gene therapy,” Knudten added.