- Natalie Holles, the chief executive of Audentes Therapeutics, has departed the company as the gene therapy developer's new owner Astellas Pharma fully folds the biotech into its larger organization.
- Audentes, which was acquired by Astellas for $3 billion almost a year and a half ago, will now operate under the name Astellas Gene Therapies, the company announced Wednesday.
- All 350 Audentes employees will join the newly formed unit, but Holles and "some members" of the Audentes leadership team will not transition over, an Astellas spokesperson confirmed to BioPharma Dive.
Biotech CEO departures in the wake of an acquisition by a larger pharmaceutical company are not uncommon, as many executives move on to find their next endeavor.
In Holles' case, her departure comes more than year after Astellas' acquisition closed and as the Japanese drugmaker more tightly folds the biotech into its operations.
"Although Natalie will not be transitioning to Astellas Gene Therapies, she has been instrumental in the growth and success of Audentes and throughout the integration thus far in helping to solidify a smooth transition to the current Astellas Gene Therapies leadership team," a spokesperson for the company wrote to BioPharma Dive.
The spokesperson would not comment on the reasons for Holles' exit.
Holles joined Audentes in August 2015 as its chief operating officer, the role she held when Astellas acquired the company in December 2019.
A month later, when the deal closed, Holles was promoted to replace departing chief executive Matthew Patterson as CEO of what Astellas pitched would be an "independent subsidiary" — much like Novartis had run the gene therapy company AveXis following its acquisition. (Novartis recently rebranded AveXis as Novartis Gene Therapies.)
The Astellas spokesperson described the full integration announced Thursday as a "next step in ongoing efforts to combine the strengths of the groups," rather than a change of plans.
Now rebranded, Astellas Gene Therapies will consist of three divisions in clinical development, commercialization and technical operations. Edward Conner, the former chief medical officer of Sangamo Therapeutics who joined Audentes just before the Astellas buyout, will lead the development division. Amy Pott will head up commercial and Matthew Pletcher will run operations.
The unit is at the center of Astellas' ambitions in gene therapy. But events since the deal have made clear the challenges that remain in safely designing the genetic medicines that Audentes specializes in.
Last summer, three children with a rare neuromuscular disease died after being treated with a high dose of an Audentes gene therapy, leading the Food and Drug Administration to place the entire trial on clinical hold.
The FDA has since permitted the trial to resume, but the tragedy was a stark reminder of the safety unknowns gene therapy researchers still confront as they target more and more genetic conditions. Audentes used a particularly high dose of gene therapy in its study, which involved children with X-linked myotubular myopathy. Some experts have warned against pushing gene therapy doses too high, citing potential liver and nerve risks.
In addition to myotubular myopathy, Audentes — now Astellas Gene Therapies — is developing therapies for Pompe disease, Duchenne muscular dystrophy and myotonic dystrophy type 1.