- Audentes Therapeutics, a gene therapy developer recently bought by Astellas, will invest about $110 million to build a manufacturing plant in North Carolina, joining a growing list of drugmakers choosing to locate new drug production facilities in the state.
- Pfizer, Bluebird bio and Novartis-owned AveXis all have, or are building, sites dedicated to making gene therapies in North Carolina, while Eli Lilly last month announced plans to spend $470 million on an injectable drug plant there.
- For Audentes, the decision to invest in a new facility emerged from planning for when the biotech outgrows the capacity it currently has in a South San Francisco plant, according to Donald Wuchterl, the company's head of technical operations.
Audentes cast a wide net for where to place its newest facility, eventually choosing a small town southwest of Raleigh already home to one gene therapy plant, which Pfizer's now spending $500 million to expand.
The area is well known as a life sciences hotspot, due in large part to the universities located nearby in Durham and Chapel Hill. Increasingly, though, it's become a hub for manufacturing, particularly in gene therapy, and that proved a draw for Audentes.
"It was pretty clear that the Raleigh-Durham area was a front-runner," said Audentes' Wuchterl.
Gene therapy developers choosing North Carolina for manufacturing sites
|170,00 square feet
|Approx. $200 million
|125,000 square feet
|135,000 square feet
SOURCE: Company statements, filings
News of the investment comes about two and half months after Astellas agreed to buy Audentes for $3 billion, the latest in a string of gene therapy acquisitions.
Manufacturing was one attraction of Astellas to Audentes, and the Japanese drugmaker was aware of the biotech's plans to expand into North Carolina during deal talks, according to Wuchterl.
Producing gene therapies requires developers make both the therapeutic DNA as well as the viral shell used to deliver it. For companies developing treatments for neuromuscular diseases, as Audentes is, a one-time dose can comprise billions of viral vectors, making manufacturing a potential bottleneck for both clinical development as well as any subsequent commercialization.
Contract manufacturers like Lonza, Catalent and Thermo Fisher are an option, and Wuchterl said Audenetes considered whether outsourcing would make sense before ultimately choosing to expand on its own.
Audentes' most advanced therapy treats x-linked myotubular myopathy, a rare and usually fatal neuromuscular disease that affects infants and young boys. The biotech is currently making the experimental candidate at its South San Francisco site, but executives sought to backstop supply with another site that could support future growth too.
Astellas, which is testing its own gene therapies in preclinical studies, could benefit as well, although that's not the direct aim.
"This capacity is needed for Audentes' purposes, but it serves the greater good of the entire combined Astellas-Audentes gene therapy entity that has come to fruition from the acquisition," the executive said.
Construction will occur over three phases, Audentes said, the first of which will take place over roughly 18 months. More than 200 jobs will be created in connection with the facility, according to the company.