Strongbridge Biopharma plc Announces CEO Transition Plan and Provides Preliminary Third Quarter 2019 Financial Results and Corporate Updates
Mr. Johnson is a recognized leader in the biopharmaceutical industry with more than 30 years of experience at leading global organizations, including
Additionally, Strongbridge today reported preliminary and unaudited financial results and provided a corporate update for the third quarter ended September 30, 2019. The Company will announce its full third quarter 2019 financial results on November 7, 2019.
Preliminary Third Quarter 2019 Financial Results and Corporate Updates
Rare Neuromuscular Franchise: KEVEYIS® (dichlorphenamide)
- Strongbridge anticipates that it will report KEVEYIS®(dichlorphenamide) net product sales of
$5.7 millionduring the third quarter of 2019, a 36 percent increase compared to $4.2 million during the third quarter of 2018.
- The Company remains on track to meet or exceed the top end of the full-year 2019 KEVEYIS revenue guidance of
$18M to $20M.
Rare Endocrine Franchise: RECORLEV™ (levoketoconazole)
- Enrollment in the Phase 3 LOGICS study of RECORLEV™ (levoketoconazole) in endogenous Cushing’s syndrome is approximately two-thirds complete. The Company projects that all of the patients required to complete enrollment have been identified, with most in titration and maintenance, and the remainder in screening. Top-line results are now anticipated in the second or third quarter of 2020.
- The Company plans to submit a New Drug Application for RECORLEV to the U.S. Food and Drug Administration approximately six months after reporting top-line LOGICS results.
- Strongbridge also expects to report quarter-end cash and cash equivalents of approximately
$79.6 million, and no outstanding debt, as of September 30, 2019.
- Strongbridge and NovoNordisk are engaged in discussions following receipt of a notice from NovoNordisk that indicates as of
December 1, 2019, it intends to cease the use and funding of the Strongbridge field team for the promotion of MACRILENä (macimorelin) in the U.S.
“As executive chairman, I will continue to work closely with the board of directors, executive management and the broader team to lead the organization while a formal search is conducted to identify a new CEO. We look forward to providing additional details on our financial results and corporate updates when we report full third quarter results later this week. On behalf of the board of directors, we would like to thank Matt for his contributions to the Company and we wish him well in his future endeavors,” said
Third Quarter 2019 Reporting and Conference Call Details
Strongbridge will announce its full third quarter 2019 financial results and host a conference call on
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 the anticipated timing for the release of top-line data from the LOGICS study and the submission of an NDA for RECORLEV to the
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Source: Strongbridge Biopharma plc