UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

Pursuant to Section 13a-16 or 15d-16 of the Securities Exchange Act of 1934

 

For the month of April 2016

 

Commission File Number:  001-37569

 

STRONGBRIDGE BIOPHARMA plc

(Exact name of Registrant as specified in its charter)

 

900 Northbrook Drive

Suite 200

Trevose, PA 19053

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F x   Form 40-F o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):           

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):           

 

 

 



 

On April 4, 2016, Strongbridge Biopharma plc (the “Registrant”) issued a press release regarding a presentation at the Endocrine Society’s 2016 Annual Meeting and Expo.

 

The information contained in the press release is being furnished to the Commission and shall not be deemed incorporated by reference into any of the Registrant’s registration statements or other filings with the Commission.

 

Exhibits

 

Exhibit
Number

 

Exhibit Table

99.1

 

Press Release issued by Strongbridge Biopharma plc, dated April 4, 2016.

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

Dated: April 4, 2016

STRONGBRIDGE BIOPHARMA PLC

 

 

 

 

 

By:

/s/ Stephen Long

 

 

Stephen Long

 

 

Chief Legal Officer

 

3


Exhibit 99.1

 

CONFIDENTIAL DRAFT — NOT FOR DISTRIBUTION

 

 

Strongbridge Biopharma plc Announces Presentation of COR-003 Data at the

Endocrine Society’s 2016 Annual Conference

 

April 4, 2016 - Dublin, Ireland and Trevose, Pa., USA — Strongbridge Biopharma plc (Nasdaq: SBBP), a global rare disease biopharmaceutical company focused on the development and commercialization of novel therapeutic options, today announced that pharmacology data for COR-003 (levoketoconazole) from preclinical experiments and a clinical study evaluating COR-003 in healthy subjects were presented at the Endocrine Society’s 2016 Annual Meeting and Expo being held in Boston, MA from April 1-4, 2016.

 

COR-003, Strongbridge’s lead product candidate, is a cortisol inhibitor currently being studied in the global Phase 3 SONICS trial for the treatment of endogenous Cushing’s syndrome.

 

“Strongbridge is proud to be a part of the rare disease community and scientific exchange taking place at the Endocrine Society’s 2016 Annual Meeting,” said Ruth Thieroff-Ekerdt, M.D., chief medical officer of Strongbridge Biopharma. “The pharmacology data presented at this meeting add to the growing body of evidence supporting the potential utility of COR-003 in Cushing’s syndrome, where there is significant unmet need in terms of diagnosis and treatment of patients with this rare endocrine disorder.”

 

The poster, entitled Pharmacology of COR-003 (levoketoconazole), an investigational treatment for endogenous Cushing’s syndrome, was presented on Saturday, April 2, 2016.

 

About Strongbridge Biopharma

 

Strongbridge Biopharma is a global rare disease biopharmaceutical company focused on the development and commercialization of novel therapeutic options. Strongbridge’s lead product candidate, COR-003 (levoketoconazole), is a cortisol inhibitor currently being studied in the global Phase 3 SONICS trial for the treatment of endogenous Cushing’s syndrome. Strongbridge’s rare endocrine disease franchise also includes COR-005, a next-generation somatostatin analog (SSA) being investigated for the treatment of acromegaly, with potential additional applications in Cushing’s syndrome and neuroendocrine tumors. Both COR-003 and COR-005 have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strongbridgebio.com.

 

Forward-Looking Statements

 

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, 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.

 

Contacts:

 

Corporate and Media Relations

Elixir Health Public Relations

Lindsay M. Rocco

+1 862-596-1304

[email protected]

 

Investor Relations

ICR Inc.

Stephanie Carrington

+1 646-277-1282

[email protected]

 

USA

900 Northbrook Drive

Suite 200

Trevose, PA 19053

Tel. +1 610-254-9200

Fax. +1 215-355-7389