KemPharm Announces U.S. Launch of Innovative ADHD Treatment AZSTARYS™ (serdexmethylphenidate and dex
Wednesday, July 21, 2021
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KemPharm Announces U.S. Launch of Innovative ADHD Treatment AZSTARYS™
(serdexmethylphenidate and dexmethylphenidate capsules) by Corium, Inc.
Celebration, FL – July 21, 2021 – 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). An
estimated 8.4% of children and 2.5% of adults have ADHD.
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, CFA
Tiberend
Strategic Advisors, Inc.
(212)
375-2665 / 2664
[email protected]
[email protected]
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