KemPharm Receives Day-74 Letter for KP415 NDA
19 May 2020 - 9:30PM
KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company
engaged in the discovery and development of proprietary prodrugs,
today confirmed that the Company has received a filing
communication from the U.S. Food and Drug Administration (FDA),
commonly known as the “Day-74 Letter.” The Day-74 Letter
stated that the New Drug Application (NDA) for KP415 is
sufficiently complete to permit a substantive review by the FDA,
and that the target goal date under the Prescription Drug User Fee
Act (PDUFA) is March 2, 2021. In addition, the Day-74 Letter
indicated that the FDA is not currently planning to hold an
advisory committee to discuss the KP415 NDA.
“As expected, the FDA has set the PDUFA date for
March 2, 2021, and we are pleased that the regulatory process is
proceeding based on the promulgated timeframes,” said Travis C.
Mickle, Ph.D., President and CEO of KemPharm. “This is
another important regulatory milestone for KP415, and we look
forward to working together with our partners at GPC and Corium to
support the regulatory process and commercial preparation
activities needed to facilitate a potential launch in the second
half of 2021, if approved.”
KP415 is KemPharm’s investigational product
candidate for the treatment of attention deficit hyperactivity
disorder (ADHD), which contains serdexmethylphenidate (SDX),
KemPharm’s prodrug of d-methylphenidate (d-MPH). In September
2019, KemPharm entered into the License Agreement with an affiliate
of Gurnet Point Capital (GPC) for the exclusive worldwide rights to
develop, manufacture and commercialize KemPharm’s product
candidates containing SDX, including KemPharm’s ADHD product
candidates, KP415 and KP484. GPC’s portfolio company, Corium,
Inc., will lead all commercialization activities for KP415.
About KP415:
KP415 consists of SDX co-formulated with
immediate-release d-MPH and is designed to address unmet needs with
the most widely-prescribed methylphenidate ADHD treatments,
including earlier onset of action and longer duration of therapy,
while avoiding unnecessary spikes in d-MPH concentrations that may
be associated with adverse events. In addition, results from
the various Human Abuse Potential trials for the SDX component of
KP415 suggest that the prodrug alone may have lower abuse potential
than relevant d-MPH comparators.
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, and stimulant use disorder. KemPharm’s co-lead
clinical development candidates for the treatment of ADHD, KP415
and KP484, are both based on a prodrug of d-methylphenidate, but
have differing duration/effect profiles. 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 the Company’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, including the potential FDA
approval of the KP415 NDA, the potential commercial launch of
KP415, and the potential clinical benefits of KP415 or any of our
product candidates, 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 Annual Report on Form 10-K for the year
ended December 31, 2019, and KemPharm’s other Periodic and Current
Reports filed 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 McEnroeTiberend Strategic
Advisors, Inc.(212) 375-2665 /
2664jrando@tiberend.commmcenroe@tiberend.com
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