AveXis announced plans to create the manufacturing facility in North Carolina in June 2018, a project that would create 200 new jobs for the state.
“We welcome the new jobs and investment that AveXis brings to our region,” said North Carolina Representative, Zack Hawkins. “These jobs will add vitality to our community as this company works to bring new hope to families facing difficult health challenges.”
In return for Novartis’ investment, after it acquired AveXis in April 2018, the state government will provide the company $1.4m (€1.23m) reimbursement over 12 years, depending on tax revenues generated by the positions created at the facility.
Expansion in the Research Triangle Park area follows on from similar decisions by GSK, Biogen and Accord Healthcare.
Expected first approval
Total investment by Novartis will reach $115m for the Durham site, which looks set to expand manufacturing capacity ahead of potential approval of AveXis lead candidate, Zolgensma (onasemnogene abeparvovec).
The gene therapy is currently being evaluated by the US Food and Drug Administration (FDA) under priority review for the treatment of spinal muscular atrophy (SMA).
“Our primary focus is to bring gene therapies to patients suffering from devastating rare neurological genetic diseases, such as SMA, genetic amyotrophic lateral sclerosis and Rett syndrome. Continued investment in our infrastructure in North Carolina will allow us to manufacture multiple gene therapies simultaneously, helping us reach more patients, faster,” said Andy Stober, chief technical officer of AveXis.
A decision by the FDA is expected by May 2019 on Zolgensma, and would potentially emerge as a competitor to the only current treatment on the market, Biogen’s Spinraza (nusinersen).
