AveXis Expands with Biologics Manufacturing Campus in Longmont, Colorado
According to company officials the facility will allow the firm to further expand AveXis' production capacity as it prepares to launch Zolgensma (onasemnogene abeparvovec-xioi1), an investigational gene therapy awaiting global regulatory approvals for the treatment of spinal muscular atrophy Type 1 and for future gene therapy treatments in development.
AveXis currently has a fully-operational state-of-the-art manufacturing facility in Illinois, is building a facility in North Carolina 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.
"Our Longmont, Colorado, campus, along with our existing manufacturing sites in Illinois, California and North Carolina, will play a crucial role in helping us achieve the future manufacturing capacity required to meet the global patient need for novel gene therapies," said Andrew Knudten, Senior Vice President, Global Strategic Operations. "We have built a team with exceptional depth of experience, unified by a common mission: to positively impact the lives of patients and families devastated by rare and life-threatening neurological genetic diseases. We are eager to add the talented team in Longmont to AveXis, and we hope that they will choose to join us as we build world-leading manufacturing capabilities in gene therapy."
"AveXis' success requires not just medical breakthroughs, but innovations in R&D and manufacturing. With the opening of our fourth location in the US, we will create more than 1,000 high-tech biologics manufacturing jobs by the end of 2019," said Dave Lennon, President. "AveXis has now established leading technical manufacturing capabilities with the capacity to deliver our robust pipeline, as well as the flexibility to enter into multiple external partnerships as the development and manufacturing partner of choice in gene therapy."
In December, the 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 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.
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