KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company
engaged in the discovery and development of proprietary prodrugs,
today announced that the U.S. Food and Drug Administration (FDA)
has approved the New Drug Application for (NDA) AZSTARYS™ (formerly
referred to as KP415), a once-daily product for the treatment of
attention deficit hyperactivity disorder (ADHD) in patients age six
years and older. AZSTARYS consists of serdexmethylphenidate (SDX),
KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with
immediate-release d-MPH.
Corium, Inc. (Corium), a portfolio company of
Gurnet Point Capital (GPC), will lead the commercialization of
AZSTARYS per the definitive collaboration and license agreement
(the “License Agreement”) between KemPharm and an affiliate of GPC.
Corium expects to make AZSTARYS commercially available in the U.S.
as early as the second half of 2021.
“The FDA approval of the AZSTARYS NDA is a
transformational event for KemPharm and, we believe, an important
advancement in the treatment of ADHD,” said Travis C. Mickle,
Ph.D., President and CEO of KemPharm. “Today’s approval highlights
both the value potential of SDX, our prodrug of d-MPH, and the
ability of our LAT® platform technology to develop new prodrugs of
approved medications that improve one or more of the attributes of
the parent drug. We look forward to continuing our support of
Corium as they forge ahead with the commercial launch of
AZSTARYS.”
“Today’s approval by the FDA is met with great
excitement for this innovative new ADHD therapy and the potential
it holds to meet the unmet needs of children, adolescents and
adults,” said Perry Sternberg, CEO of Corium. “Our team is
mobilized to put our commercial plans into action as the approval
of the AZSTARYS NDA now enables us to finalize our preparations for
commercial launch as early as the second half of this year.”
Ann Childress, M.D., President of the Center for
Psychiatry and Behavioral Medicine and an investigator in the
AZSTARYS clinical trial, commented: “The ADHD industry, and
specifically the MPH space, has seen little innovation in recent
years, leaving prescribers and patients desiring new treatment
options. In my research and practice, three properties are
repeatedly cited by patients and their caregivers as being
underserved by current ADHD medications: onset of action, duration
of effect and consistency of therapy. Having investigated AZSTARYS
and directly observed its clinical impact on patients, I believe
this product will be an important new tool for physicians to use in
providing effective care for patients with ADHD.”
As a result of the FDA’s approval of the
AZSTARYS NDA, KemPharm has earned a regulatory milestone payment
following FDA approval as provided under the License Agreement, and
KemPharm is working with GPC to evaluate the related provisions and
amounts. Under the License Agreement, KemPharm may be eligible for
up to $468 million in regulatory and sales milestone payments, as
well as tiered royalty payments, on a product-by-product basis for
net sales, with potential percentages up to the mid-twenties for
U.S. net sales, and up to the mid-single digits of net sales in
each country outside of the U.S.
The complete label for AZSTARYS, including
prescribing information and important safety information, may be
found at www.kempharm.com/pipeline-products/#kp415.
The complete label may also be downloaded in PDF
format
here: http://ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315.
Conference Call
Information:
KemPharm will host a conference call and live
audio webcast with slide presentation tomorrow, Wednesday, March 3,
2021, at 8:30 a.m. ET, to discuss FDA approval of the AZSTARYS
NDA. Interested participants and investors may access
the conference call by dialing either:
- (866) 395-2480 (U.S.)
- (678) 509-7538 (international)
- Conference ID: 4272912
An audio webcast with slide presentation will be
accessible via the Investor Relations section of the Company’s
website, http://investors.kempharm.com/. An archive of the
webcast and presentation will be available for 90 days beginning
tomorrow, March 3, 2021, at approximately 9:30 a.m. ET.
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.23
The ADHD market accounted for
approximately $17.9 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 97% 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
AZSTARYSTM:
AZSTARYSTM 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: http://ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315.
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 product portfolio is highlighted by
AZSTARYS™, an FDA-approved, once-daily treatment for attention
deficit hyperactivity disorder (ADHD) which is based on
serdexmethylphenidate, (SDX), KemPharm’s prodrug of
d-methylphenidate (d-MPH). KemPharm is also advancing several
clinical development candidates, including KP484 for the treatment
of ADHD and KP879 for the treatment of Stimulant Use Disorder
(SUD). AZSTARYS, KP484, and KP879 are all based on SDX. In
addition, KemPharm has received FDA approval 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, including without
limitation KemPharm’s proposed development and commercial
timelines, 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 include statements about the
commercial launch of AZSTARYS, including the timing of launch, the
regulatory milestone payment, and the potential clinical benefits
of AZSTARYS. These forward-looking statements 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 the “Risk
Factors” sections of KemPharm’s Annual Report on Form 10-K for the
year ended December 31, 2019, KemPharm’s Quarterly Report on Form
10-Q for the quarter ended September 30, 2020, 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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