Xeris to acquire Strongbridge pipeline, including Recorlev for Endogenous Cushing’s
As a result of the transaction, Xeris will also acquire Strongbridge’s pipeline, which includes Recorlev (levoketoconazole), an investigational treatment for endogenous Cushing syndrome.
“Strongbridge’s attractive rare disease portfolio and capabilities are very complementary to 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, ”said Paul R. Edick, President and CEO of Xeris , in a press release. Press release.
“We are delighted to partner with Xeris to lead the next phase of our growth,” said John H. Johnson, CEO of Strongbridge. “Strongbridge has made significant progress in advancing its portfolio of therapies for rare endocrine and rare neuromuscular diseases. This includes… the successful development of Recorlev (levoketoconazole), which is under consideration for FDA approval with marketing expected 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 pituitary gland in the brain (Cushing’s disease) or in the adrenal glands at the back. above the kidneys. Recorlev is designed to block the production of cortisol.
Strongbridge recently submitted a New Drug Application (NDA) for Recorlev to the United States Food and Drug Administration (FDA), requesting approval of Recorlev for the treatment of endogenous Cushing’s syndrome. The FDA is reviewing the request, with a decision expected in early 2022.
SONICS recruited and treated 94 people with endogenous Cushing. LOGICS recruited participants from SONICS and other patients, and focused on evaluating the effects of stopping treatment.
The SONICS results were promising, with 30% of participants seeing their cortisol levels normalize after six months of treatment, without requiring a dose increase during this time. Consistently, LOGICS data suggests that stopping treatment leads to increased cortisol levels.
Further results from these studies indicated that treatment with Recorlev may reduce the risk of heart disease, relieve Cushing’s symptoms, lower cholesterol and body fat, and help control diabetes in people with syndrome. Endogenous cushing. Treatment has also been shown to reduce 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 in previous studies will continue to receive Recorlev for up to three years.
Under the new acquisition agreement, Strongbridge shareholders will receive a fixed exchange ratio of shares of Xeris Biopharma Holdings for each share of Strongbridge they hold. Once the merger is complete, current Xeris shareholders are expected to own approximately 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 talents and commercial infrastructure will enable us to accelerate product launches and drive 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,” added Johnson.