AveXis, a Novartis company, has signed an agreement to purchase an advanced biologics therapy manufacturing campus in Longmont, Colorado, to expand its manufacturing capacity for its investigational gene therapy, Zolgensma (onasemnogene abeparvovec-xioi). Zolgensma is under regulatory review for treating spinal muscular atrophy.

The Longmont facility will add to AveXis’ manufacturing network. AveXis has a manufacturing facility in Illinois, is building a facility in North Carolina that is scheduled to be operational in 2020, and is expanding its product-development capacity at its San Diego facility. The addition of the six-building Longmont campus consists of nearly 700,000 square feet of space for biologic drug manufacturing, offices, laboratories, warehousing and utilities. Initial start-up activities in Longmont will include preparing the facility for scaling, manufacturing and testing of gene therapies and hiring staff.

In December 2018, the US Food and Drug Administration 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 the FDA, with regulatory action anticipated in May 2019. In addition, the drug is anticipated to receive approval in Japan and the European Union later this year, according to the company.

Source: Novartis