Novartis’ AveXis doubles down with $115M manufacturing investment

As an FDA action date quickly approaches for a gene therapy that Novartis snatched up last year, the biotech that is developing the treatment says it needs to more than double the size of its new manufacturing operations. AveXis now plans to have 400 employees and invest about $115 million in the North Carolina site.

AveXis, which Novartis grabbed in an $8.7 billion deal, announced it will invest another $60 million and hire another 200 workers for the site it is building in Durham, North Carolina. That is on top of the $55 million it last year pledged to invest in the plant when it first projected it would hire 200 employees.

"Continued investment in our infrastructure in North Carolina will allow us to manufacture multiple gene therapies simultaneously, helping us reach more patients, faster," Andy Stober, senior VP of technical operations, said in a statement.

In exchange for the investments, AveXis will get about $1.4 million in state incentives.

Initial plans were for AveXis to build a 170,000-square-foot facility in Durham which would primarily produce drug substance, while a 50,000-square-foot plant the biotech has at its headquarters outside of Chicago was expected to produce both clinical and commercial product. Construction on the new Durham facility began last year and is slated be completed in the second half of 2020.

A spokeswoman for AveXis said in an email today that the additional investment will be used to further develop the existing space for additional capacity.

Now a unit of Novartis, AveXis is working on developing gene therapies for rare neurological diseases—such as SMA, genetic amyotrophic lateral sclerosis and Rett syndrome. Its initial candidate, Zolgensma, is a gene therapy targeted at spinal muscular atrophy, or SMA Type 1, which is the leading genetic cause of infant mortality. The therapy has been granted breakthrough therapy designation and a priority review by the FDA. Its regulatory action is expected in May this year.

Novartis CEO Vas Narasimhan is making a sizable bet on new therapies like gene treatments and radio-drug conjugates as the drugs of the future. In 2017, Novartis became the first drugmaker to win an approval globally for a cell therapy—Kymriah. The new drugs also come with new and tricky manufacturing methods. The rollout of Kymriah has been hindered by a manufacturing setbackthat the company is working to overcome.

Shortly after Kymriah’s approval, Gilead Sciences’ won an FDA OK for its CAR T treatment Yescarta. Since then, Spark Therapeutics has also won an approval for blindness gene therapy Luxturna.

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