Xeris to Acquire Strongbridge Pipeline, Including Recorlev

Xeris Pharmaceuticals and Strongbridge Biopharma have entered an agreement in which Xeris will acquire Strongbridge, forming a new entity called Xeris Biopharma Holdings.

Following the transaction, Xeris also will acquire Strongbridge’s pipeline, which includes Recorlev (levoketoconazole), an investigational treatment for endogenous Cushing’s syndrome.

“Strongbridge’s attractive rare disease portfolio and capabilities are highly complementary with Xeris. We look forward to welcoming the Strongbridge team to Xeris and leveraging our differentiated portfolios and technologies to help the patients we serve improve their quality of life,” Paul R. Edick, chairman and CEO of Xeris, said in a press release.

“We are excited to combine with Xeris to drive the next phase of our growth,” said John H. Johnson, CEO of Strongbridge. “Strongbridge has made significant progress advancing its portfolio of therapies for rare endocrine and rare neuromuscular diseases. This includes … the successful development of Recorlev (levoketoconazole), which is under review for approval by the FDA with expected commercialization in the first quarter of 2022 pending FDA approval.”

Endogenous Cushing’s syndrome is caused by abnormally high levels of the stress response hormone cortisol, usually due to the presence of a tumor in the brain’s pituitary gland (Cushing’s disease), or in the adrenal glands found on top of the kidneys. Recorlev is designed to block the production of cortisol.

Strongbridge recently submitted a new drug application (NDA) for Recorlev to the U.S. Food and Drug Administration (FDA), requesting Recorlev’s approval for the treatment of endogenous Cushing’s syndrome. The FDA is reviewing the application, with a decision expected in early 2022.

Strongbridge’s NDA submission was supported mainly by data from two Phase 3 trials, one called SONICS (NCT01838551) and the other called LOGICS (NCT03277690).

SONICS enrolled and treated 94 people with endogenous Cushing’s. LOGICS enrolled participants from SONICS and additional patients, and focused on evaluating the effects of treatment withdrawal.

Results from SONICS were promising, with 30% of participants seeing their cortisol levels normalize after six months of treatment, without requiring any dose increments during that period. Consistently, data from LOGICS suggested that withdrawing treatment causes cortisol levels to rise.

Other findings from these studies have indicated that treatment with Recorlev can lower the risk of heart disease, ease Cushing’s symptoms, lower cholesterol levels and body fat, and help control diabetes in people with endogenous Cushing’s syndrome. The treatment also has been shown to ease depression and improve patients’ quality of life.

Strongbridge’s NDA also included safety data from an ongoing open-label trial, OPTICS (NCT03621280), in which participants from previous studies will continue receiving Recorlev for up to three years.

Under the terms of the new acquisition agreement, Strongbridge shareholders will receive a fixed exchange ratio of Xeris Biopharma Holdings stock for every share of Strongbridge stock they own. When the merger is complete, current Xeris shareholders are expected to own about 60% of the combined company, while current Strongbridge shareholders are expected to own the remaining 40%.

“Through this combination with Xeris, we will gain additional scale and financial resources to better meet the unmet needs of those we serve. Our combined pipeline, drug development talent and commercial infrastructure will enable us to accelerate product launches and drive further growth,” said Johnson.

“We look forward to working closely with the Xeris team to unlock the potential value of our combined assets, while providing our shareholders with the opportunity to participate in the success of the combined company,” Johnson added.