Ionis Signs Distribution Deal with Sobi and Cuts 70 Percent of Akcea Workforce

Rare Daily Staff

Ionis Pharmaceuticals, disclosed in an SEC filing that its subsidiary Akcea Therapeutics entered into a distribution agreement with Swedish Orphan Biovitrum for Tegsedi in North America, and in conjunction with that deal, will cut almost 70 percent of Akcea’s workforce.

Ionis established Akcea as a subsidiary in 2015 to help commercialize a growing pipeline of rare disease therapies developed using Ionis’ antisense technology; and spun it out in an IPO in 2017 while maintaining majority control. Ionis brought it back into the fold in August 2020.  

Under the terms of the deal with Sobi, Akcea retains the marketing authorizations for Tegsedi in the United States and Canada. The company will continue to supply commercial product to Sobi and manage regulatory and manufacturing processes, as well as relationships with key opinion leaders, and continue to lead the Tegsedi global commercial strategy. Akcea’s and Ionis’ commercial portfolio includes two marketed drugs: Waylivra, approved in the European Union as a treatment for familial chylomicronemia syndrome, an ultra-rare, debilitating metabolic disease; and Tegsedi for the treatment of adult polyneuropathy of hereditary transthyretin-mediated amyloidosis, a progressive, systemic, and fatal inherited disease.

Akcea has not had much success in marketing the drugs, with U.S. regulators rejecting approval of Waylivra, and combined sales of both drugs reaching just $70 million in 2020, according to Ionis’ regulatory filing.

In connection with the new deal with Sobi, on April 5, 2021, Ionis enacted a plan to reorganize its Akcea workforce in North America, which it said would better align with the immediate needs of its business and to focus on high priority programs within the company’s wholly owned pipeline, including its next generation LICA program for IONIS-TTR-LRx. This involved reducing its Akcea workforce by nearly 70 percent, most of whom were from the Tegsedi field team in the U.S. and Canada.

The reorganization plan was approved by the Ionis’ Board of Directors on March 26, 2021, subject to the execution of the Sobi deal. The affected employees were informed on April 5, 2021 and are eligible to receive severance payments and other customary benefits. Ionis expects to incur restructuring charges in the range of $11 million to $14 million principally in the quarter ending June 30, 2021.