Strongbridge Biopharma plc Provides Update on Corporate Progress
Strongbridge Expands Key Functional Area Expertise With Senior Hires
Strongbridge Provides Update on Cash Position
"Strongbridge has made significant progress in a short amount of time executing against its strategic plan to become a leader in providing innovative therapeutic options to patients with rare endocrine disorders and other rare diseases," said
Strongbridge's lead product candidate, COR-003 (levoketoconazole), is currently being studied in a pivotal Phase 3 clinical trial for the treatment of endogenous Cushing's Syndrome. Patient enrollment in the Phase 3 trial continues to progress. As previously stated, the Company expects to report top-line data during the first half of 2017 and to file for regulatory approval in the second half of 2017. For more information about the trial, visit: http://cushingssyndromestudy.com/.
Results from a secondary efficacy analysis of the completed Phase 2 trial for COR-004, a novel second-generation antisense compound, which is in clinical development for acromegaly and designed to block the synthesis of growth hormone receptor (GHr) thereby reducing levels of insulin-like growth factor-1 (IGF-1) in the blood, were recently presented at the Society for Endocrinology BES2015 conference. These data provide further evidence for the efficacy of COR-004 and its ability to inhibit growth hormone receptor (GHR) expression.
COR-003 and COR-005, a next-generation somatostatin analog (SSA) with a unique receptor affinity profile, being investigated for the treatment of acromegaly, with potential additional applications in Cushing's disease and neuroendocrine tumors, have received orphan designation from both the
The Company is pursuing orphan designation for COR-004, and engaging with regulatory agencies to determine future development plans.
Strongbridge Expands Key Functional Area Expertise with Senior Hires
Strongbridge has expanded its clinical development, regulatory affairs, operations and finance teams to help execute against the Company's strategic plans. Recently, the Company welcomed
Fredric Cohen, M.D., is an endocrinologist with more than 20 years of therapeutics development and related experience in the life science industry, more recently focused in rare disease and specialty products, at companies, including Aptalis Pharma, Johnson & Johnsonand Eli Lilly & Company.
James R. Englund, CPA, CMA, has nearly 30 years of experience in finance and accounting fields, with nearly 15 years in pharmaceutical industry finance for commercial-stage companies, including Auxilium Pharmaceuticals, Inc., where he most recently served as corporate controller for nearly 10 years. Jim has also held positions at IMS Health Corporation and Aventis Behring Corporation.
Susan Thorntonhas nearly 20 years of senior regulatory affairs experience with specialty pharmaceutical companies, including Antares Pharma, Aptalis Pharma, Inc., Barrier Therapeutics and Teva Pharmaceuticals USA.
Peter J. Valentinssonhas more than 25 years of technical operations experience and has held positions of increasing seniority at both large pharmaceutical and biotechnology companies, including NPS Pharmaceuticals, Inc., which was recently acquired by Shire, and Schering-Plough Research Institute.
"We are excited to welcome Fred, Jim, Sue and Pete to Strongbridge," said
Strongbridge Provides Update on Cash Position
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements. These statements relate to future events and involve known and unknown risks, including, without limitation, uncertainties regarding Strongbridge's strategy, plans, future financial position, outcomes of product development efforts and objectives of management for future operations. 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. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.
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