Gene therapy manufacturing facility
AveXis is investing an additional $60m in its new gene therapy manufacturing facility in Durham County, North Carolina, US.
The facility was first announced in May 2018 and was estimated to cost $55m. The centre will enable the company to scale-up production of transformational therapies for rare neurological genetic diseases.
The project is expected to create 200 new jobs with an average payroll of $104,000. With positions including engineering, manufacturing, quality control and supply chain roles, the number of jobs is expected to reach 400 by the end of 2020.
AveXis’s continued investment in North Carolina will boost the state’s biotechnology industry.
AveXis’s new gene therapy manufacturing plant is located in a leased property at 2500 South Tri-Center Boulevard in Durham.
The Research Tri Center South warehouse is located within the Research Triangle Park region, which is close to the Raleigh-Durham International Airport. The site is well connected to North Carolina Highway 147 and interstates 40 and 85. It provides access to Raleigh, Durham, Chapel Hill, and Cary in North Carolina.
The new facility will manufacture AveXis’s initial product candidate ZOLGENSMA©, which was formerly known as AVXS-101.
The ZOLGENSMA gene therapy product candidate treats three types of spinal muscular atrophy (SMA), a rare neuromuscular disease and one of the most common genetic causes of infant death. It addresses the main cause of Type 1 SMA, which has very few treatment options.
AveXis submitted the biologics license application (BLA) for ZOLGENSMA to the Food and Drug Administration (FDA) in December 2018. The drug has received breakthrough therapy designation and has been granted priority review status by the FDA, while regulatory action is anticipated in May 2019.
Regulatory applications for the drug have also been submitted in Europe and Japan.
In addition to ZOLGENSMA, AveXis plans to develop new drugs for the treatment of rare neurological diseases such as Rett syndrome and amyotrophic lateral sclerosis.
AveXis’s Durham manufacturing facility is supported by the North Carolina Department of Commerce and the Economic Development Partnership of North Carolina (EDPNC) in partnership with the North Carolina Biotechnology Center, the North Carolina General Assembly and the North Carolina Community College System, as well as the Greater Durham Chamber of Commerce and Durham County.
The North Carolina Economic Investment Committee agreed to provide $1.44m under the Job Development Investment Grant (JDIG) in May 2018 to support the facility for 12 years. The company will repay the funds along with tax revenues generated by the new jobs over the 12-year term.
The facility will contribute an estimated $1.3bn to North Carolina’s economy during the period. It will also provide up to $483,000 to the state’s Industrial Development Fund – Utility Account, according to the JDIG deal.
Headquartered in Bannockburn, Illinois, AveXis develops and commercialises gene therapies to treat rare and fatal neurological genetic diseases. It was acquired by Switzerland-based pharmaceutical firm Novartis for $8.7bn in May 2018.
AveXis operates a state-of-the-art manufacturing site in the Chicagoland area in Illinois, US.
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