Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV® (levoketoconazole) for the Treatment of Cushing’s Sy...
03 Juin 2021 - 10:01PM
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 issued U.S. Patent
No. 11,020,393 entitled, “Methods of Treating Disease with
Levoketoconazole” which covers a method of treating Cushing’s
syndrome patients with RECORLEV® (levoketoconazole) who also take
metformin for Type 2 diabetes. The term of the U.S. patent will
expire on March 2, 2040.
This will be the third patent issued in the U.S.
relating to RECORLEV. The first, U.S. Patent No. 9,198,906, covers
methods of reducing C-reactive protein levels and systemic
inflammation through administration of a once-daily dose of
RECORLEV and will expire on December 29, 2030. The second, U.S.
patent No. 9,918,984, covers methods of treating Cushing’s syndrome
with levoketoconazole and will expire on January 10, 2026.
RECORLEV is an adrenal steroidogenesis inhibitor
with a New Drug Application that is currently under review by the
U.S. Food and Drug Administration for the treatment of endogenous
Cushing’s syndrome.
About Cushing’s
SyndromeEndogenous Cushing’s syndrome, is a rare, serious
and potentially lethal endocrine disease caused by chronic elevated
cortisol exposure - often the result of a benign tumor of the
pituitary gland. This benign tumor tells the body to overproduce
high levels of cortisol for a sustained period of time, and this
often results in undesirable physical changes. The disease is most
common among adults between the ages of 30 to 50, and it affects
women two times more often than men. Women with Cushing's syndrome
may experience a variety of health issues including menstrual
problems, difficulty becoming pregnant, excess male hormones
(androgens), primarily testosterone which can cause hirsutism
(growth of coarse body hair in a male pattern), oily skin, and
acne. Additionally, the internal manifestations of the disease are
potentially life threatening. These include metabolic changes such
as high blood sugar, or diabetes, high blood pressure, high
cholesterol, fragility of various tissues including blood vessels,
skin, muscle and bone, and psychologic disturbances such as
depression, anxiety and insomnia. Untreated, the five-year survival
rate is only approximately 50 percent.
About RECORLEVRECORLEV®
(levoketoconazole) is an investigational adrenal steroidogenesis
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 has demonstrated in two
successful Phase 3 studies to significantly suppress serum cortisol
and has the potential to be a next-generation cortisol
inhibitor.
The Phase 3 program for RECORLEV includes 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 LOGICS study,
which met its primary endpoint and key secondary endpoint, 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. The ongoing long-term open
label OPTICS study will gather further useful information related
to the long-term use of RECORLEV.
RECORLEV has received orphan drug designation
from the FDA and the European Medicines Agency for the
treatment of endogenous Cushing's syndrome.
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 rare endocrine
franchise includes RECORLEV® (levoketoconazole), an adrenal
steroidogenesis inhibitor with a New Drug Application that is
currently under review by the FDA for the treatment of endogenous
Cushing’s syndrome, and veldoreotide extended release, a
pre-clinical next-generation somatostatin analog being investigated
for the treatment of acromegaly and potential additional
applications in other conditions amenable to somatostatin receptor
activation. Both RECORLEV and veldoreotide have received orphan
drug designation from the FDA and the European Medicines Agency.
The company’s rare neuromuscular franchise includes
KEVEYIS® (dichlorphenamide), the first and only FDA-approved
treatment for hyperkalemic, hypokalemic, and related variants of
primary periodic paralysis. KEVEYIS has orphan drug exclusivity in
the United States.
Forward-Looking StatementsThis
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 Strongbridge’s strategy, plans, intellectual
property portfolio, outcomes of product development efforts and
objectives of management for future operations. Forward-looking
statements involve risks and uncertainties that could cause actual
results to differ materially from those expressed in such
statement, including risks and uncertainties associated with
clinical development and the regulatory approval process, the
reproducibility of any reported results showing the benefits of
RECORLEV, the adoption of RECORLEV by physicians, if approved, as
treatment for any disease and the emergence of unexpected adverse
events following regulatory approval and use of the product by
patients. Additional risks and uncertainties relating to
Strongbridge and its business can be found under the heading “Risk
Factors” in Strongbridge’s Annual Report on Form 10-K for the year
ended December 31, 2020 and its subsequent Quarterly
Reports on Form 10-Q, as well as its other filings with
the SEC. 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 RelationsElixir Health
Public RelationsLindsay Rocco+1
862-596-1304lrocco@elixirhealthpr.com
Investor RelationsSolebury TroutMike Biega+1
617-221-9660mbiega@soleburytrout.com
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