Strongbridge Biopharma plc Announces Additional Steps to Improve Operational Efficiencies and Appoints New Lead Independent Director
~ The Company Remains Focused on Completing the LOGICS Study and Submitting a New Drug Application (NDA) for RECORLEV™ (levoketoconazole), While Ensuring Continued Growth and Profitability of KEVEYIS® (dichlorphenamide) and Serving the Unmet Needs of the
Strongbridge intends to optimize its resources for completing the development of RECORLEV™ (levoketoconazole) and continuing to grow KEVEYIS® (dichlorphenamide), and expects to realize an estimated annualized cost savings of approximately
“We believe that this reduction in force, coupled with the recent elimination of all commercial costs related to MACRILEN, will better align the Company’s resources with our long-term strategic priorities,” said
Strongbridge also today announced the appointment of Garheng Kong, M.D., Ph.D., to Lead Independent Director of the Company’s Board of Directors.
“Garheng has exceptional experience in creating and building high-growth and innovation-based healthcare businesses. On behalf of the board of directors, we are pleased to welcome him to this new role,” Johnson added.
Dr. Kong is founder and managing partner of
As previously reported in Strongbridge’s third quarter 2019 financial results:
John H. Johnson, who has served as chairman of Strongbridge since 2015, recently assumed the position of executive chairman, and is leading the organization while the board of directors conducts a formal search to identify a new chief executive officer;
- The Company remains on track to meet or exceed the top end of the full-year 2019 KEVEYIS® revenue guidance range of
$18 million to $20 million;
- The Company had
$79.6 millionof cash and cash equivalents and no debt outstanding as of September 30, 2019; and
- The Company extended its cash runway guidance by at least three months, and now believes it can fund operations as currently planned through the second quarter of 2021.
RECORLEV™ (levoketoconazole) is an investigational cortisol synthesis inhibitor in development for the treatment of patients with endogenous Cushing’s syndrome, a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. RECORLEV is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. RECORLEV is believed to significantly suppress serum cortisol in healthy subjects and has the potential to be a next-generation cortisol inhibitor.
The Phase 3 program for RECORLEV consists of SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints, demonstrating a statistically significant normalization rate of urinary free cortisol at six months. The ongoing LOGICS study is a double-blind, placebo-controlled randomized-withdrawal study of RECORLEV that is designed to supplement the long-term efficacy and safety information supplied by SONICS.
RECORLEV has received orphan drug designation from the
KEVEYIS® (dichlorphenamide) is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. In clinical studies, the most common side effects of KEVEYIS were a numbness or tingling, difficulty thinking and paying attention, changes in taste, and confusion. These are not all of the possible side effects that you may experience with KEVEYIS. Talk to your doctor if you have any symptoms that bother you or do not go away. You are encouraged to report side effects to
This press release contains forward-looking statements within the meaning of the federal securities laws. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements, including statements related to potential organizational changes and related cost savings, charges related to organizational changes, expected revenues, future cash balances, Strongbridge’s strategy, plans, status and objectives of management for future operations. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statement, including risks and uncertainties associated with clinical development and the regulatory approval process, the reproducibility of any reported results showing the benefits of a product, the adoption of a product by physicians, if approved, as treatment for any disease and the emergence of unexpected adverse events following regulatory approval and use of the product by patients. Additional risks and uncertainties relating to Strongbridge and its business can be found under the heading “Risk Factors” in Strongbridge’s Annual Report on Form 10-K for the year ended
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Source: Strongbridge Biopharma plc