KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company
engaged in the discovery and development of proprietary prodrugs,
today announced the U.S. commercial launch of AZSTARYS™, a
once-daily product for the treatment of attention deficit
hyperactivity disorder (ADHD) in patients age six years and older.
Corium, Inc. (Corium), a portfolio company of Gurnet Point Capital
(GPC), is leading the commercialization of AZSTARYS in the U.S.
AZSTARYS was approved by the U.S. Food and Drug
Administration (FDA) in March 2021 and consists of
serdexmethylphenidate (SDX), KemPharm’s prodrug of
d-methylphenidate (d-MPH), co-formulated with immediate-release
d-MPH. Subsequent to the approval of AZSTARYS, SDX was classified
as a Schedule IV controlled substance by the U.S. Drug Enforcement
Administration (DEA). AZSTARYS is classified as a Schedule II
controlled substance as it includes a 70:30 mixture of SDX
(Schedule IV) and d-MPH (Schedule II).
“The U.S. commercial launch of AZSTARYS is a
significant milestone for KemPharm and an important advancement in
the treatment of ADHD, a disease indication that has seen little
innovation in recent years,” said Travis C. Mickle, Ph.D.,
President and CEO of KemPharm. “Since the FDA’s approval of
AZSTARYS in March, the various teams across Corium have been
working diligently to ready AZSTARYS for its U.S. launch. We
believe Corium has built a best-in-class commercial organization,
and as a result, we expect the market potential for AZSTARYS will
be maximized. It is great news that patients living with ADHD will
now have a new treatment option with the potential to address
previously unmet needs because of AZSTARYS’ unique prodrug
platform.”
“The launch of AZSTARYS provides patients with
ADHD, their caregivers, and their clinicians with a
first-of-its-kind treatment that offers both rapid and extended
ADHD symptom improvement because of the dual action of its
formulation using the prodrug SDX with IR d-MPH,” said Perry J.
Sternberg, President and CEO of Corium. “We believe Corium’s
extensive ADHD and commercialization expertise will help ensure a
successful AZSTARYS launch, and I am incredibly proud of our team
for reaching this milestone, a significant inflection point in
Corium’s journey to become a leader in the CNS space.”
Ann Childress, M.D., President of the Center for
Psychiatry and Behavioral Medicine and an investigator in the
AZSTARYS clinical trial, commented: “My decades of research in the
ADHD space and treating patients with the condition has allowed me
to be a firsthand witness to the evolution of ADHD drug development
and implementation. Based on this perspective, I believe that
AZSTARYS represents a true advance in ADHD medicine due to its
unique combination of SDX, a prodrug of d-MPH, co-formulated with
immediate release d-MPH, which provides both immediate release and
consistent benefit throughout the course of the day. As a result, I
believe AZSTARYS will soon become a drug of preference for
physicians seeking to provide effective care for patients with
ADHD.”
About Attention Deficit Hyperactivity
Disorder (ADHD):
Attention-deficit/hyperactivity disorder (ADHD)
is one of the most common mental disorders affecting children. ADHD
also affects many adults. Symptoms of ADHD include inattention (not
being able to keep focus), hyperactivity (excess movement that is
not fitting to the setting) and impulsivity (hasty acts that occur
in the moment without thought).1 An estimated 8.4% of children and
2.5% of adults have ADHD.2,3
The U.S. ADHD market accounted for
approximately $17.5 billion of revenue in 2019 with a
year-over-year prescription growth rate greater than four percent
(4%). Within this, the branded portion of the ADHD market was
approximately $7.4 billion in 2019, with extended-release
products representing more than 95% of the branded
prescriptions. In 2019, the methylphenidate segment of
the ADHD market accounted for approximately 20 million
prescriptions and $4.9 billion in sales.
About AZSTARYS:
AZSTARYS is an FDA-approved, once-daily product
for the treatment of attention deficit hyperactivity disorder
(ADHD) in patients age six years or older. AZSTARYS consists of
SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated
with immediate release d-MPH.
The complete approved prescribing information
for AZSTARYS may be downloaded in PDF format here:
https://kempharm.com/wp-content/uploads/2021/03/AZSTARYS-Master-Label-Final_20210302.pdf
About KemPharm:
KemPharm is a specialty pharmaceutical company
focused on the discovery and development of proprietary prodrugs to
treat serious medical conditions through its proprietary LAT®
(Ligand Activated Therapy) technology. KemPharm utilizes its
proprietary LAT® technology to generate improved prodrug versions
of FDA-approved drugs as well as to generate prodrug versions of
existing compounds that may have applications for new disease
indications. KemPharm’s prodrug product candidate pipeline is
focused on the high need areas of attention deficit hyperactivity
disorder, or ADHD, stimulant use disorder (SUD) and CNS rare
diseases, including idiopathic hypersomnia (IH). KemPharm’s lead
clinical development candidate for the treatment of SUD, KP879, is
based on its prodrug of d-methylphenidate, known as
serdexmethylphenidate (SDX). In addition, KemPharm has received FDA
approval for AZSTARYS, a new once-daily treatment for ADHD in
patents age six years and older, and for APADAZ®, an
immediate-release combination product containing benzhydrocodone, a
prodrug of hydrocodone, and acetaminophen. For more information on
KemPharm and its pipeline of prodrug product candidates visit
www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook
and YouTube.
Caution Concerning Forward Looking
Statements:
This press release may contain forward-looking
statements made in reliance upon the safe harbor provisions of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements include all statements that do not
relate solely to historical or current facts and can be identified
by the use of words such as “may,” “will,” “expect,” “project,”
“estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,”
“continue” or the negative versions of those words or other
comparable words. Forward-looking statements are not guarantees of
future actions or performance. These forward-looking statements,
including the potential benefits of AZSTARYS, the potential
commercial success of AZSTARYS, and AZSTARYS becoming a drug of
preference for physicians treating patients with ADHD, are based on
information currently available to KemPharm and its current plans
or expectations and are subject to a number of uncertainties and
risks that could significantly affect current plans. Risks
concerning KemPharm’s business are described in detail in
KemPharm’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2021, and KemPharm’s other filings with the Securities
and Exchange Commission. KemPharm is under no obligation to, and
expressly disclaims any such obligation to, update or alter its
forward-looking statements, whether as a result of new information,
future events or otherwise.
KemPharm Contacts:
Jason Rando / Maureen McEnroe, CFATiberend
Strategic Advisors, Inc.(212) 375-2665 /
2664jrando@tiberend.commmcenroe@tiberend.com
1 American Psychiatric Association
(https://www.psychiatry.org/patients-families/adhd/what-is-adhd) 2
Danielson, ML, et al. Prevalence of Parent-Reported ADHD
Diagnosis and Associated Treatment Among U.S. Children and
Adolescents, 2016. Journal of Clinical Child & Adolescent
Psychology, Volume 47, 2018 - Issue 23 Simon V ,
Czobor P, Bálint S , et al: :Prevalence and
correlates of adult attention-deficit hyperactivity
disorder: a meta-analysis. Br J
Psychiatry194(3):204–211, 2009
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