Supernus Announces that its Partner Shire Receives FDA Approval for Mydayis™ for ADHD
June 21 2017 - 12:37PM
Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty
pharmaceutical company focused on developing and commercializing
products for the treatment of central nervous system (CNS)
diseases, today announced that the U.S. Food and Drug
Administration (FDA) has approved MydayisTM (mixed salts of a
single-entity amphetamine product), a once-daily treatment
comprised of three different types of drug-releasing beads for
patients 13 years and older with Attention Deficit Hyperactivity
Disorder (ADHD). Mydayis is not for use in children 12 years and
younger. Shire expects to make Mydayis commercially available in
the United States in the third quarter of 2017.
Mydayis was originally developed by Shire Laboratories, the
former division of Shire that subsequently became Supernus
Pharmaceuticals. Based on the agreement between Supernus and Shire,
Shire will pay to Supernus a single digit percentage royalty on net
sales of the product.
“We believe Mydayis clinical profile represents a novel
treatment for ADHD patients. Having shown efficacy lasting up to 16
hours after taking one capsule, beginning at 2 or 4 hours
post-dose, this novel product should prove to be an important
option treatment for many patients 13 years and older,” said Jack
Khattar, President and CEO of Supernus Pharmaceuticals.
For full prescribing and safety information on Mydayis,
refer to Shire’s press release dated June 20, 2017.
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 diseases. The Company currently
markets Trokendi XR® (extended-release topiramate) for the
prophylaxis of migraine and the treatment of epilepsy and Oxtellar
XR® (extended-release oxcarbazepine) for the treatment of epilepsy.
The Company is also developing several product candidates to
address large market opportunities in psychiatry, including SPN-810
for the treatment of Impulsive Aggression in ADHD patients and
SPN-812 for the treatment of ADHD.
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 market
potential or success of Mydayis, 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 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 SEC
filings 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.
Mydayis is a trademark of Shire LLC.
CONTACTS:
Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
or
INVESTOR CONTACT:
Peter Vozzo
Westwicke Partners
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com
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