Supernus Announces Paragraph IV ANDA Filing for Oxtellar XR(R)
December 10 2014 - 7:30AM
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) today announced that
on December 9, 2014 the Company received a Paragraph IV Notice
Letter from TWi Pharmaceuticals, Inc. ("TWi") advising
Supernus of the filing by TWi of an Abbreviated New Drug
Application seeking approval for oxcarbazepine extended-release
tablets. Supernus is currently reviewing the details of this Notice
Letter and intends to vigorously enforce its intellectual property
rights relating to Oxtellar XR. The product is currently protected
by four issued patents that expire no earlier than 2027.
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
markets two 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 Company's ability to defend and enforce its intellectual
property rights covering Oxtellar XR. Actual results may differ
materially from those in these forward-looking statements as a
result of various factors, including, but not limited to, the
ability of Supernus to finance potential litigation and to prevail
in any such proceeding to successfully defend its intellectual
property rights. 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 21, 2014 under
the caption "Risk Factors". 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
Or
INVESTOR CONTACT:
COCKRELL GROUP
877.889.1972
investorrelations@thecockrellgroup.com
cockrellgroup.com
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