Strongbridge Biopharma Receives Notice of Allowance from U.S. Patent and Trademark Office for New Patent Covering RECORLEV™...
January 18 2018 - 7:30AM
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, today 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
BiopharmaStrongbridge 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.
Forward-Looking StatementsThis
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,
intellectual property portfolio 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 Rocco +1 862-596-1304
lrocco@elixirhealthpr.com
Investor RelationsU.S.:The Trout Group Marcy
Nanus +1 646-378-2927 mnanus@troutgroup.com
Europe:First HouseMitra Hagen Negård+47 21 04
62 19strongbridgebio@firsthouse.no
USA 900 Northbrook Drive Suite 200 Trevose,
PA 19053 Tel. +1 610-254-9200 Fax. +1 215-355-7389
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