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Strongbridge Biopharma Receives Notice of Allowance from U.S. Patent and Trademark Office for New Patent Covering RECORLEV (levoketoconazole) for the Treatment of Cushing’s Syndrome

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Friday, January 19, 2018

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Strongbridge Biopharma plc (Nasdaq:SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, announced that the United States Patent and Trademark Office (USPTO) has entered a Notice of Allowance for U.S. Patent Application 15/088,539 covering the use of RECORLEV (levoketoconazole), a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome.

The claims of the U.S. patent application entitled, "Methods And Compositions For Treating Diabetes, Metabolic Syndrome And Other Conditions," are directed towards methods of treating Cushing's syndrome with levoketoconazole. This Notice of Allowance concludes the substantive examination of the patent application and should result in the issuance of a U.S. patent after administrative processes are completed. The term of the U.S. patent scheduled to issue from this application will expire January 10, 2026, plus any time allowed for a patent term extension. This will be the second method of use patent issued in the U.S. relating to RECORLEV. The first, U.S. Patent No. 9,198,906, issued in December of 2015, covers methods of reducing C-reactive protein levels and systemic inflammation through administration of a once-daily dose of RECORLEV and will expire December 29, 2030.

"The patent scheduled to issue from this application should result in additional intellectual property protection for RECORLEV, potentially extending our drug candidate's patent term beyond orphan drug exclusivity and enhancing the overall RECORLEV patent portfolio," said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. "This marks an important step in our ongoing efforts to optimize the value of RECORLEV and further strengthens Strongbridge's leadership position in rare endocrine disease," Pauls added.

About Endogenous Cushing's Syndrome
Endogenous Cushing's syndrome (CS) is a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. Most people with CS have a variety of signs and symptoms – many of which, when they occur by themselves, are common and do not necessarily point to an underlying disease; this makes recognition of CS difficult. Common presenting symptoms include weight gain or obesity, fatigue, muscle weakness, headaches, mood or sleep disturbances, facial rounding or redness, excess body hair growth in women or baldness in men, thinned skin with stretch marks, easy bruising and other skin changes including acne, mood or sleep disturbances and irregular periods or loss of libido. Patients are often found by their doctors to have new-onset or worsening of high blood pressure, abnormal levels of blood lipids, such as cholesterol, polycystic ovaries and abnormal blood glucose or diabetes. People with uncontrolled disease are seriously ill and have a 2- to 4-fold higher mortality rate than age- and gender-matched controls, mainly due to metabolic and cardiovascular complications. Treatment options for CS include surgery, radiation therapy, and medical treatment. Cushing's syndrome most commonly affects adults ages 20-50 and is more prevalent in females, accounting for about 70 percent of all cases.

About Strongbridge Biopharma
Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge's commercial portfolio within its rare neuromuscular and rare endocrine franchises includes KEVEYIS (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis, and MACRILEN (macimorelin), the first and only FDA-approved oral drug indicated for the diagnosis of Adult Growth Hormone Deficiency. KEVEYIS has orphan drug exclusivity status in the U.S. to August 2022. MACRILEN has been granted orphan drug designation in the U.S. and has patents with expiration dates through late 2027. The Company's rare endocrine franchise also includes a clinical-stage pipeline of therapies: RECORLEV (levoketoconazole), a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome, and veldoreotide, a next-generation somatostatin analog being investigated for the treatment of acromegaly, with potential additional applications in other conditions amenable to somatostatin receptor activation. Both RECORLEV and veldoreotide have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strongbridgebio.com.

Contacts:

Corporate and Media Relations
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
Email: Emlrocco@elixirhealthpr.com

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Email: mnanus@troutgroup.com

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Mitra Hagen Negård
+47 21 04 62 19
Email: strongbridgebio@firsthouse.no

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Trevose, PA 19053
Tel. +1 610-254-9200
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Source: Strongbridge Biopharma plc
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