Supernus Announces Issuance of First Use Patents Protecting SPN-812 as a Novel Non-Stimulant ADHD Product
January 27 2014 - 9:00AM
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.
About SPN-812
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 IIb trial.
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 on August 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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