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Adding to an existing $115-million investment, the 700,000-ft2 site in Longmont, CO will expand AveXis’ gene-therapy manufacturing capacity.
On April 1, 2019, AveXis, a Novartis company specializing in gene therapies, announced it signed an agreement to purchase an advanced biologics therapy manufacturing site in Longmont, CO to expand gene-therapy manufacturing production capacity.
The expanded capacity will accommodate the launch of the company’s investigational gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), for the treatment of spinal muscular atrophy (SMA) Type 1 and for future gene-therapy treatments in development. The drug is designed to address the monogenic root cause of SMA and prevent further muscle degeneration. In December 2018, FDA accepted the company's biologics license application for use of Zolgensma with SMA Type 1 patients. The drug previously received breakthrough therapy designation and has been granted priority review by FDA, with regulatory action expected in May 2019, according to AveXis. Additionally, the company expects the drug to receive approval in Japan and the European Union in late 2019.
The new Longmont campus consists of six building and nearly 700,000 ft2 of space for biologic drug manufacturing, offices, laboratories, warehousing, and utilities. Initial start-up activities will include preparing the facility for scaling, manufacturing, and testing of gene therapies and hiring staff. AveXis states that it plans to offer positions to all approximately 150 employees previously employed at the site and to announce further expansion of new jobs in the near term.
The new site joins the company’s fully-operational manufacturing facility in Illinois. Currently, the company is building another facility in Durham, NC, scheduled to be operational in 2020, and is also expanding its product development capacity at its San Diego, CA facility.
According to AveXis, the acquisition of the Longmont site complements an existing $115-million investment in the company’s Durham facility, creating more than 1000 United States-based, high-tech, biologics manufacturing jobs by the end of 2019.