Supernus Announces Issuance of First Use Patents Protecting SPN-812 as a Novel
Non-Stimulant ADHD Product
ROCKVILLE, Md., Jan. 27, 2014 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals,
Inc. (Nasdaq:SUPN), a specialty pharmaceutical company, today announced the
issuance of a European patent (number 2341912) and Canadian patent (number
2,735,934) for SPN-812, its novel non-stimulant product candidate for the
treatment of ADHD. These patents will provide protection for the product with
expiration that is no earlier than 2029. Supernus has several additional
patent applications for SPN-812 pending in other geographic regions, including
the United States.
"These are the first patents to issue on SPN-812 covering its novel use as a
non-stimulant for treatment of ADHD. We expect the product to have a highly
differentiated clinical profile. Long term protection provided by the various
patent applications coupled with its new chemical entity (NCE) status in the
U.S. market is critical to realizing the full commercial value for this
product," said Jack A. Khattar, President and CEO of Supernus.
SPN-812 is a selective norepinephrine reuptake inhibitor that Supernus
believes could be more effective and with an improved side effect profile
compared to other non-stimulant treatments for ADHD due to its different
pharmacological profile. The active ingredient in SPN-812 has an extensive
safety record in Europe, where it was previously marketed for many years as an
antidepressant. The product successfully completed a randomized, double-blind,
placebo-controlled trial in 52 adults with a current diagnosis of ADHD (26
subjects per treatment group). SPN-812 met the study's primary endpoints of
safety and tolerability, and achieved overall significant median reductions
from baseline in investigator-rated CAARS total ADHD symptom scores by study
end, -11.5 points vs. -6.0 for placebo (p=0.0414) and in self-rated CAARS
total symptom scores by study end, -10.5 points vs. -1.0 for placebo
(p=0.0349). Conners' Adult ADHD Rating Scale, or CAARS, is a commonly-used
measurement for ADHD in adults.
We continue to progress SPN-812 and have completed the development of several
extended release formulations that will be tested in a pharmacokinetic study
in the first half of 2014 to select the final formulation for use in the Phase
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on developing and commercializing products for the treatment of central
nervous system, or CNS, diseases. The Company has two marketed products for
epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR™
(extended-release topiramate). The Company is also developing several product
candidates in psychiatry to address large market opportunities in ADHD,
including ADHD patients with impulsive aggression. These product candidates
include SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.
Forward Looking Statements
This press release contains forward-looking statements regarding the potential
efficacy of SPN-812 and intellectual property protection of this product
candidate. Actual results may differ materially from those in these
forward-looking statements as a result of various factors, including, but not
limited to, risks regarding the company's ability to obtain all required
regulatory approvals of this product candidate, the Company's ability to
commercialize the product candidate successfully, whether physicians will
prescribe and patients will use the product candidate, and competition in the
market. For a further description of these and other risks facing the Company,
please see the risk factors described in the Company's Annual Report Form 10-K
that was filed with the United States Securities and Exchange Commission on
March 15, 2013 and under the caption "Risk Factors" and the updates to these
risk factors in the Company's quarterly report form 10-Q that was filed with
the Commission onAugust 14, 2013. Forward-looking statements speak only as of
the date of this press release, and the company undertakes no obligation to
update or revise these statements, except as may be required by law.
CONTACT: Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
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