AveXis Acquires Colorado Manufacturing Facility Ahead of May PDUFA Date for Zolgensma
Nearly six weeks after announcing plans to expand a facility in North Carolina, Novartis subsidiary AveXis plans to acquire a manufacturing facility in Longmont, Colorado to provide additional production capacity for its planned launch of Zolgensma, a gene therapy treatment for spinal muscular atrophy.
In its announcement Monday, AveXis said the Colorado facility will become the largest of the four sites involved in manufacturing its gene therapy treatments for SMA, as well as other planned treatment in development for rare genetic diseases. In addition to the N.C. site, which is expanding, and the planned Colorado site, AveXis also has manufacturing facilities in Illinois and San Diego. The Longmont campus will provide an additional 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 about 150 employees. AveXis said it plans to offer positions to the employees currently working at the facility and will announce additional job expansion in the future – presumably, after the U.S. Food and Drug Administration gives its final decision on AVXS-101, now dubbed Zolgensma, a gene therapy to treat Spinal Muscular Atrophy (SMA) Type 1. The regulatory agency is set to make a decision on the gene therapy in May. AveXis did not disclose the name of the current manufacturing site owner.
Andrew Knudten, senior vice president of global strategic operations for AveXis, said the Colorado site, along with its three other manufacturing facilities, will play a significant role in helping the company meet the need of patients.
“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,” Knudten said in a statement.
AveXis did not disclose the financial details of the acquisition of the Colorado manufacturing facility. But, the company did say that the Longmont campus investment adds to existing $115 million investment in Durham facility that was announced in February.
AveXis has rapidly expanded its manufacturing in anticipation of a potential FDA approval of Zolgensma. Dave Lennon, company president, said by the end of 2019, AveXis will have created more than 1,000 high-tech biologics manufacturing jobs to help it deliver its gene therapies. Also, the additional manufacturing staff will provide AveXis the “flexibility to enter into multiple external partnerships as the development and manufacturing partner of choice in gene therapy,” Lennon said.
AveXis was acquired by Novartis for $8.7 billion in 2018. When Zolgensma was granted Priority Review by the FDA, the price point for the treatment, which could be a “one-and-done” procedure, was pegged between $4 and $5 million. Despite the multi-million cost of the one-and-done treatment, the Boston-based nonprofit organization Institute for Clinical and Economic Review has actually pegged Zolgensma as more cost effective than the only SMA treatment on the market, Biogen’s Spinraza, which requires annual injections that have a price tag of $375,000 per year.