Less than a year after buying a U.S. plant from AstraZeneca, Novartis’ biotech AveXis has it ready for production of Zolgensma, its gene therapy for spinal muscular atrophy. The new plant will help it get the treatment for the rare genetic disease to more patients. It also is building a plant in North Carolina that is expected to open this year.
AveXis officially company opened the plant Tuesday with many of the 150 employees who worked at the facility before AstraZeneca closed it in January 2019, the Daily Camera reported.
“Our ability to get an intact, 150-person team, from day one, allowed us to move very quickly to transform the site from its prior operation to this new cutting-edge technology,” Dave Lennon, president of AveXis, said at the event, the newspaper reported. The plant current has 350 employees and AveXis expects to have 400 working there by year end, a spokesperson said in an email today. While operational, the site is not expected to be licensed and producing clinical or commercial supply until 2021.
AveXis acquired the 700,000-square-foot, six-building campus in Longmont, in April of last year. Along with manufacturing space, the campus has offices, laboratories, warehousing and utilities.
The biotech has an existing manufacturing site in Illinois. In 2018, it announced plans to build a new facility in Durham, North Carolina, and then last year announced it would more than double the size of that site to 400 employees, with an investment of about $115 million. That plant is also expected to be operational this year and producing commercial product next year.
The production build-up is key because Novartis has indicated it wants to make sure it has sufficient global supply to meet demand for Zolgensma and other gene therapies in development, something with which it has struggled with its first gene therapy, CAR-T drug Kymriah. That is because the FDA set higher specifications for cell variability and the number of inactive cells for the commercial release of Kymriah than the drugmaker achieved in trials.
Novartis has been making manufacturing tweaks to address the issues but is also trying to convince the FDA to set the standards to those achieved during trials. During the recent ASH meeting, the Swiss company released data that showed the effectiveness of the drug was unaffected when there were viable cells of 60% to up to 80%. The FDA set the threshold at 80%.