KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company
engaged in the discovery and development of proprietary prodrugs,
today announced that the United States Patent and Trademark Office
(USPTO) has recently issued two (2) new patents to KemPharm
governing methods of use and composition of matter for
methylphenidate-based prodrugs. These newly-issued patents have an
expiration date of December 9, 2037, which is an extension of
approximately five (5) years past the previously-issued patents
generally describing compositions based on a prodrug of
d-methylphenidate (serdexmethylphenidate or SDX). KP415 and KP484,
KemPharm’s clinical development candidates for the treatment of
attention deficit hyperactivity disorder (ADHD), are both SDX-based
formulations.
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. (Corium), will lead all
commercialization activities for KP415.
The first patent (US 10,584,112) generally
describes a specific stereoisomer compound of SDX and various other
compositions. The second patent (US 10,584,113) generally describes
compositions comprising unconjugated d-methylphenidate in
combination with a specific stereoisomer compound of SDX.
“Issuance of these U.S. patents significantly
strengthens the intellectual property portfolio governing
KemPharm’s SDX-based product candidates, including our ADHD
franchise, which is led by KP415,” said Travis C. Mickle, Ph.D.,
President and CEO of KemPharm. “The additional five years of patent
protection afforded by the issuance of these patents is
well-aligned with the ongoing effort by GPC and Corium to prepare
KP415 for potential commercialization, if approved. Based on
previous communications from FDA, the anticipated PDUFA date for
KP415 is March 2, 2021.”
“We are pleased that these two additional
patents have been issued for SDX, extending the potential life
cycle of the product candidates, KP415 and KP484, to 2037,” said
Dr. Sophie Kornowski, Senior Partner at GPC. “The extension of time
significantly enhances the overall value of these innovative ADHD
treatments and further supports the investment thesis for our
partnership with KemPharm.”
About KP415 and KP484:
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.
KP484 is KemPharm’s co-lead clinical development
candidate being developed for the treatment of ADHD in patients
that respond best when a very long duration of therapy is required.
Similar to KP415, KP484 is based on SDX. Preclinical and clinical
studies of KP484 have demonstrated that the prodrug may produce a
longer duration release of d-MPH compared to the most prescribed
methylphenidate products. KP484 has the potential to be the first
new methylphenidate-based product being developed with the intent
to address the specific needs of the adult ADHD population.
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.
About Gurnet Point Capital:
Gurnet Point Capital is a unique healthcare
fund founded by Ernesto Bertarelli and led by Christopher
Viehbacher, who, together, have decades of expertise in an industry
for which they share a passion, both as Chief Executives and as
investors. With an initial allocation of $2 billion, GPC is
investing long-term capital and supporting entrepreneurs in
building a new generation of companies. Based in Cambridge, MA, its
remit is global, encompassing life sciences and medical
technologies. The fund invests across all stages of product
development through to commercialization and does so with an
approach that is a hybrid of venture and private equity investing
strategies. www.gurnetpointcapital.com.
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 timing and
probability of potential FDA approval of the KP415 NDA, the
potential commercial launch of KP415, the potential product life
cycle of KP415 or KP484. 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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