Event Held Today, October 11, 2018
KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company
focused on the discovery and development of proprietary prodrugs,
today provided highlights from its investor event featuring a
discussion with key opinion leaders (KOLs) and prescribing
physicians in the field of Attention Deficit Hyperactivity Disorder
(ADHD). The event was held in New York, NY, on Thursday,
October 11, 2018.
The KemPharm ADHD Investor Event was organized
to provide investors with a comprehensive review of the dynamics
influencing the ADHD treatment landscape, including current
challenges and unmet medical needs, as well as an overview of
KemPharm’s ADHD prodrug portfolio, which is highlighted by its two
lead investigational prodrug candidates for treating ADHD, KP415
and KP484.
Keynote speakers included Ann Childress, MD,
President of the Center for Psychiatry & Behavioral Medicine in
Las Vegas and Adjunct Faculty Member at the University of Nevada
School of Medicine; Matthew Brams, MD, Medical Director and
Principal, Bayou City Research, and Clinical Associate Professor of
Psychiatry at the Baylor College of Medicine; and Timothy E.
Wilens, MD, Chief, Division of Child and Adolescent Psychiatry and
Co-Director, Center for Addiction Medicine at the Massachusetts
General Hospital, and Associate Professor of Psychiatry at Harvard
Medical School in Boston.
“We are very honored to have had the opportunity
to conduct an ADHD Investor Event featuring such an esteemed panel
of experts in ADHD treatment,” said Travis Mickle, Ph.D., President
and Chief Executive Officer of KemPharm. “As we advance KP415
towards a first quarter 2019 New Drug Application (NDA), we are
continually reminded of the myriad dynamics impacting the ADHD
space and the desire among prescribers and patients for therapeutic
options that better address key unmet medical needs, including
early onset of action, duration of therapy and lower abuse
potential. On behalf of KemPharm, I would like to personally thank
Drs. Childress, Brams and Wilens for discussing these important
opportunities and where next-generation ADHD therapies, such as
KP415 and KP484, could help to improve the lives of ADHD patients
and their caregivers.”
The full webcast and presentation slides from
the KOL Investor Event can be accessed via the Investor Relations
section under “Events & Presentations” on the KemPharm's
website at http://investors.kempharm.com.
The following is a recap of key presentations
from the event:
ADHD Treatment Landscape and Using the
Laboratory Classroom to Determine Drug EffectsLed by Ann
Childress, MD, the first presentation provided a review of the ADHD
patient and treatment landscape, including key benefits and
drawbacks of current ADHD medications and potential opportunities
for improvement as developers seek to bring new products to
market. Additionally, Dr. Childress focused on the design and
execution of an ADHD classroom-style clinical study and measures
that are used for determining efficacy. Included in Dr.
Childress’ presentation was a discussion of the SKAMP and PERMP
tests and the data that each is designed to provide, as well as
examples and impressions from the KP415.E01 efficacy study.
Prescribing ADHD Medications in a Large
Outpatient Practice: The Good, The Bad, and the UglyIn the
next presentation, Matthew Brams, MD, discussed in detail the
current ADHD treatment market and the advantages and disadvantages
of generic and branded medications. Importantly, Dr. Brams
highlighted key unmet needs that he believes must be addressed by
next-generation ADHD products in order for those products to
succeed. Unmet medical needs include faster onset, longer
duration, improved tolerability and once-daily dosing.
Nonmedical Use of Prescription
StimulantsIn the final KOL presentation, Timothy E.
Wilens, MD, discussed the prevalence of stimulant misuse,
particularly the abuse of ADHD medications by college-age
individuals. In his remarks, Dr. Wilens noted that
amphetamines are the most common stimulant misused and that the
oral and intranasal routes are preferred by misusers, highlighting
the need for next-generation ADHD medications that reduce the
potential of abuse.
KemPharm – ADHD Prodrug Portfolio and
Corporate UpdateConcluding the ADHD Investor Event, Travis
Mickle, Ph.D., reviewed the latest developments and anticipated
milestones involving KP415 and KP484, KemPharm’s co-lead clinical
development candidates for the treatment of ADHD. Dr. Mickle
re-affirmed that KemPharm expects to file the NDA for KP415 in the
first quarter of 2019, while the NDA submission for KP484 is
expected to follow later in 2019. Additionally, Dr. Mickle
discussed the ongoing strategic partnering discussions involving
KP415 and KP484 and provided an update on the recently completed
$25 million follow-on offering.
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 LATTM
(Ligand Activated Therapy) platform technology. KemPharm
utilizes its proprietary LAT platform technology to generate
improved prodrug versions of FDA-approved drugs in the high need
areas of ADHD, pain and other central nervous system disorders.
KemPharm’s co-lead clinical development candidates are KP415 and
KP484, both based on a prodrug of d-methylphenidate, but with
differing extended-release/effect profiles for the treatment of
ADHD. 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, 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 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
June 30, 2018, filed with the Securities and Exchange Commission
(SEC) on August 10, 2018, and KemPharm’s other Periodic and Current
Reports filed with the SEC. 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.
Investor/Media Contacts:
Jason Rando / Joshua Drumm, Ph.D.Tiberend Strategic
Advisors, Inc.212-375-2665 /
2664jrando@tiberend.comjdrumm@tiberend.com
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