Just like that, Akcea Therapeutics’ top leadership is out. CEO Paula Soteropoulos, President Sarah Boyce and Chief Operating Officer Jeff Goldberg are bidding the company adieu. Akcea’s board installed Ionis CBO Damien McDevitt as interim CEO.
Soteropoulos and Boyce gave up their board seats, with Joseph “Skip” Klein III, an Ionis board member, and Michael Yang, Acadia’s chief commercial officer, replacing them. Soteropoulos and Goldberg will stay on as “advisors” to aid the transition, Akcea said in a statement.
The moves come nearly a year after Akcea’s first FDA nod, for the hereditary transthyretin-mediated amyloidosis (hATTR) treatment Tegsedi. Its second drug, Waylivra (volanesorsen) scored EU approval earlier this year, but hasn’t fared quite as well stateside. It squeaked past an FDA advisory panel in a 12-8 vote in May 2018 only to receive a Complete Response Letter from the agency three months later.
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“Damien brings significant expertise and a track record of success in both science and business from his tenure in the pharmaceutical and biotechnology industries,” said Akcea Chairman Christopher Gabrieli, in the statement. “He also has a deep understanding of the Akcea portfolio and the underlying antisense technology. Skip and Michael augment the investor, business and commercialization expertise that is already on our board. The addition of these three individuals allows us to continue to build on the launches of TEGSEDI and WAYLIVRA and invest in our promising pipeline.”
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Tegsedi and Waylivra are two of four programs that Ionis offloaded when it spun out Akcea in 2015. And there’s more where that came from: Ionis is “renewing and deepening its commitment to Akcea as it plans to license new antisense drugs to the company,” Gabrieli said. Akcea could pick up programs from other companies too, he said.
“We thank Paula, Sarah and Jeff for building a strong commercial organization that can now support the development and commercialization of additional drugs,” said Stanley Crooke, M.D., Ph.D., the chairman of Ionis, in the statement. “Akcea is well positioned to optimize the commercial success of TEGSEDI and WAYLIVRA and to support the development and the launch of additional drugs from our pipeline, including AKCEA-TTR- LRx, which will begin a Phase 3 program shortly.”
Editor's note: This story was edited to correct Sarah Boyce's role at Akcea.