Supernus Provides Regulatory Updates for SPN-812 and SPN-830
November 09 2020 - 6:30PM
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, today announced
regulatory updates for SPN-812 (viloxazine hydrochloride) for the
treatment of attention-deficit hyperactivity disorder (ADHD) in
pediatric patients 6 to 17 years of age, and SPN-830 (apomorphine
infusion pump) for the continuous treatment of motor fluctuations
(“on-off” episodes) in Parkinson’s disease (PD).
SPN-812 - Novel non-stimulant for the treatment of
ADHD
The U.S. Food and Drug Administration (FDA) has issued a
Complete Response Letter (CRL) regarding the New Drug Application
(NDA) for SPN-812 for the treatment of ADHD in pediatric patients 6
to 17 years of age. The FDA issued a CRL to indicate that the
review cycle for the application is complete and that the
application is not ready for approval in its present form.
The primary issue cited in the SPN-812 CRL relates to the
Company’s in-house laboratory that conducts analytical testing,
which recently moved to a new location. The Company plans to
discuss with the FDA the contents of the CRL and clarify to the FDA
that the application does not rely solely on this facility for
product release. We plan to discuss with the agency the steps
required for the resubmission of the NDA for SPN-812. Importantly,
no clinical safety or efficacy issues were identified during the
review.
SPN-830 (apomorphine infusion pump) - Continuous
treatment of motor fluctuations (“on-off” episodes) in
PD
The Company received a Refusal to File (RTF) letter from the FDA
regarding its NDA for SPN-830 (apomorphine infusion pump) for the
continuous treatment of motor fluctuations (“on-off” episodes) in
Parkinson’s disease (PD). In its review of the NDA, which was
submitted in September 2020, the FDA determined that the NDA was
not sufficiently complete to permit a substantive review. In the
letter, the FDA requested certain documents and reports to be
submitted in support of the application.
The Company plans to seek guidance from the FDA, including a
Type A meeting, to discuss the contents of the RTF letter and
clarify the steps required for the resubmission of the NDA for
SPN-830.
“On SPN-812, we look forward to collaborating with the FDA to
clarify and resolve the facility matter and put SPN-812 back on
track to help the millions of children and adolescents in the U.S.
with ADHD,” said Jack Khattar, President and CEO of Supernus.
“Regarding SPN-830, we remain confident in the data package for
SPN-830 and its promise as an important treatment option for PD
patients who experience motor fluctuations associated with on-off
episodes. We are fully committed to working with the FDA to address
its letter and successfully refile our SPN-830 NDA.”
The Company plans to provide updates on the NDA status and
expected launch timing for both SPN-812 and SPN-830 once it has had
further discussions with the FDA and has agreed on the path forward
for each program.
Full Year 2020
Financial Guidance
The Company reiterates its full year 2020 net product sales and
research and development expenses guidance and provides an update
to its full year 2020 selling, general and administrative expenses
and operating earnings (GAAP) guidance to reflect the expected
impact of the SPN-812 CRL on the fourth quarter of 2020. SPN-812
commercial launch preparation activities continue and Supernus
expects to achieve the following financial objectives in 2020:
Full Year 2020 Financial Objectives |
Full Year 2020
Guidance
($ in millions) |
Net product sales |
$500 - $525 |
Research and development expense |
Approximately $75 |
Selling, general and administrative expenses |
$205 – $215, as compared to prior guidance of $215 - $225 |
Amortization of intangible assets |
$16 |
Operating earnings (GAAP)(1) |
$155 - $170, as compared to prior guidance of $145 - $160 |
(1) Generally accepted accounting principles (GAAP). Operating
earnings including amortization of intangible assets.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a pharmaceutical company
focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases. The Company
markets Trokendi XR® (extended-release topiramate) for the
prophylaxis of migraine and the treatment of epilepsy; Oxtellar XR®
(extended-release oxcarbazepine) for the treatment of epilepsy;
APOKYN® (apomorphine hydrochloride injection) for the acute
treatment of hypomobility in advanced Parkinson’s disease (PD);
MYOBLOC® (rimabotulinumtoxinB) for the treatment of cervical
dystonia and treatment of chronic sialorrhea in adults; and XADAGO®
(safinamide) as an adjunctive treatment to levodopa/carbidopa in PD
patients with hypomobility. The Company is also developing several
product candidates to address large market opportunities in the CNS
market, including SPN-812 for the treatment of ADHD; SPN-830
(apomorphine infusion pump) for the continuous treatment of motor
fluctuations (“on-off” episodes) in PD; SPN-820 for
treatment-resistant depression; and SPN-817 for the treatment of
epilepsy.
See full Prescribing Information for our products
here: Trokendi XR, Oxtellar XR, APOKYN, MYOBLOC, and
XADAGO.
All trademarks are the property of their respective owners.
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.
These forward-looking statements include expectations regarding the
Company’s future interactions and communications with the FDA,
including its expectation to discuss with the FDA the issues raised
in the CRL regarding the NDA for SPN-812 for the treatment of ADHD
in pediatric patients 6 to 17 years of age and the Company’s plans
to address them, the Company’s future resubmission of the NDA for
SPN-812, the potential approval of the NDA for SPN-812 following
resubmission and the potential benefits and commercialization of
SPN-812, and the Company’s expectation to discuss with the FDA the
issues raised in the RTF letter relating to the NDA for SPN-830
(apomorphine infusion pump) and the Company’s plans to address
them, the Company’s future resubmission of the NDA for SPN-830, the
potential approval of the NDA for SPN-830 following resubmission
and the potential benefits and commercialization of SPN-830. 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 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
products and 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; 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, EVP and
Chief Financial OfficerSupernus Pharmaceuticals, Inc.Tel: (301)
838-2591
Or
Investor Contact:Peter VozzoWestwicke, an ICR CompanyOffice:
(443) 213-0505Mobile: (443) 377-4767Email:
peter.vozzo@westwicke.com
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