Supernus Announces Paragraph IV ANDA Filing for XADAGO®
May 04 2021 - 8:49PM
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, today announced
that Newron Pharmaceuticals S.p.A. (“Newron”) received a Paragraph
IV Notice Letter (“Notice Letter”) from Aurobindo Pharma Limited,
India and its wholly owned subsidiary Aurobindo Pharma USA Inc.
(collectively “Aurobindo”), advising Newron of the filing by
Aurobindo of an Abbreviated New Drug Application to the U.S. Food
and Drug Administration (“FDA”) seeking approval for safinamide
tablets. The Notice Letter is directed to the three XADAGO patents
with U.S. patent numbers 8,076,515, 8,278,485 and 8,283,380, that
expire between June 2027 and December 2028 and are listed in the
FDA's publication, Approved Drug Products with Therapeutic
Equivalence Evaluations, commonly referred to as the Orange Book.
The Company has a license agreement with Zambon S.p.A., Newron’s
partner, related to the XADAGO Patents, and as a new chemical
entity, XADAGO is under the 5 year FDA exclusivity period that
expires on March 21, 2022. The Company is currently reviewing the
details of this Notice Letter with its partners to respond as
appropriate to protect the intellectual property rights relating to
XADAGO.
About Supernus Pharmaceuticals, Inc. Supernus
Pharmaceuticals is a biopharmaceutical company focused on
developing and commercializing products for the treatment of
central nervous system (CNS) diseases.
Our diverse neuroscience portfolio includes approved treatments
for epilepsy, migraine, attention-deficit hyperactivity disorder
(ADHD), hypomobility in Parkinson’s disease, cervical dystonia and
chronic sialorrhea. We are developing a broad range of novel CNS
product candidates including new potential treatments for
hypomobility in Parkinson’s disease, epilepsy, depression, and rare
CNS disorders.For more information, please visit
www.supernus.com.
Forward-Looking Statements: This press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
do not convey historical information but relate to predicted or
potential future events that are based upon management's current
expectations. These statements are subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. In addition to
the factors mentioned in this press release, such risks and
uncertainties include, but are not limited to, the Company’s
ability to sustain and increase its profitability; the Company’s
ability to raise sufficient capital to fully implement its
corporate strategy; the implementation of the Company’s corporate
strategy; the Company’s future financial performance and projected
expenditures; the Company’s ability to increase the number of
prescriptions written for each of its products; the Company’s
ability to increase its net revenue; the Company’s ability to
commercialize its products; the Company’s ability to enter into
future collaborations with pharmaceutical companies and academic
institutions or to obtain funding from government agencies; the
Company’s product research and development activities, including
the timing and progress of the Company’s clinical trials, and
projected expenditures; the Company’s ability to receive, and the
timing of any receipt of, regulatory approvals to develop and
commercialize the Company’s product candidates; the Company’s
ability to protect its intellectual property and operate its
business without infringing upon the intellectual property rights
of others; the Company’s expectations regarding federal, state and
foreign regulatory requirements; the therapeutic benefits,
effectiveness and safety of the Company’s product candidates; the
accuracy of the Company’s estimates of the size and characteristics
of the markets that may be addressed by its product candidates; the
Company’s ability to increase its manufacturing capabilities for
its products and product candidates; the Company’s projected
markets and growth in markets; the Company’s product formulations
and patient needs and potential funding sources; the Company’s
staffing needs; and other risk factors set forth from time to time
in the Company’s filings with the Securities and Exchange
Commission made pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934, as amended. The Company undertakes no
obligation to update the information in this press release to
reflect events or circumstances after the date hereof or to reflect
the occurrence of anticipated or unanticipated events.
CONTACT:Jack A. Khattar, President and CEOJim Kelly, Executive
Vice President and CFOSupernus Pharmaceuticals, Inc.Tel: (301)
838-2591
Or
Investor Contact:Peter VozzoWestwicke/ICROffice: (443)
213-0505Mobile: (443) 377-4767Email: peter.vozzo@westwicke.com
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