KemPharm and Genco Sciences Announce Technology Licensing Agreement to Develop Prodrug-Based Therapy for Potential Rare Pedia...
October 04 2017 - 7:30AM
Agreement May Lead to Addition of New Drug Product
Candidate and Indication to KemPharm’s Prodrug Development
Pipeline
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs, announced today that it has entered into a
technology licensing and assignment agreement with Genco Sciences,
LLC (Genco).
Utilizing Genco’s early research-stage
proprietary nano-particulate amphetamine technology, KemPharm will
focus on devising an unique prodrug to be developed as a treatment
for pediatric Tourette’s syndrome when accompanied by ADHD
(attention deficit hyperactivity disorder). Genco previously
received an Orphan Designation letter from the U.S. Food and Drug
Administration’s (FDA) Office of Orphan Products Development for
its product candidate for pediatric Tourette’s syndrome.
“Today’s announcement of the license and
assignment agreement with Genco provides KemPharm’s discovery and
development team the opportunity to apply our prodrug expertise to
a potential orphan-drug area of the ADHD market,” said Travis C.
Mickle, Ph.D., President and Chief Executive Officer of KemPharm.
“In a subset of pediatric Tourette’s syndrome patients, there
is a recognized problem of ADHD that requires additional treatment
concurrent to treating the symptoms of Tourette’s.”
Under terms of the agreement, KemPharm will be
responsible for financing and managing all product
development. In exchange, KemPharm will retain full
intellectual property and commercial ownership of any product
developed as a result of this agreement, with Genco eligible to
receive certain milestone and royalty-based or value share
payments. Additional details about the agreement were not
disclosed.
“KemPharm’s success at creating unique prodrug
product candidates in multiple treatment areas allows us to see
real potential for a prodrug to be successful as the basis for
treating this rare pediatric disease,” said Subhash Desai, Ph.D.,
Chief Executive Officer of Genco. “By treating the underlying
ADHD, we believe we can unlock the door to also treating tics
and/or Tourette’s syndrome to provide an effective therapy for the
unmet needs of those affected by this complex neurologic
disorder.”
“Our goal is to discover and develop a
prodrug-based therapy that can provide an appropriate and effective
treatment for a rare pediatric disease while also successfully
completing the FDA’s regulatory approval process, which may
potentially allow us to seek a Priority Review voucher,” Dr. Mickle
continued. “Uniquely, KemPharm’s proprietary LAT prodrug
platform provides an opportunity to receive a voucher under the
current guidelines which is an example of another way that prodrugs
can be used to create value. Our agreement with Genco both builds
on this platform and potentially adds significant assets to our
development pipeline in ADHD.”
About Tourette’s Syndrome and ADHD
Tourette’s syndrome is an inherited neuropsychiatric disorder
with onset in childhood, characterized by the presence of motor and
phonic tics – the treatment goal is managing symptoms to achieve
optimum functioning, rather than eliminating symptoms; not all
persons with Tourette's require treatment, and there is no cure nor
universally effective medication.
In 90% of cases, Tourette’s syndrome exists in conjunction with
another disorder. The most frequent co-occurring condition in
people with Tourette (63%) is ADHD, though the cause of this
association is uncertain.
The Centers for Diease Control and Prevention published a series
of statistics related to Tourette’s syndrome in its “A National
Profile of Tourette Syndrome, 2011-2012.” The CDC profile is
linked as follows:
https://www.cdc.gov/ncbddd/tourette/data.html
About KemPharm
KemPharm is a clinical-stage 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 LATTM platform
technology to generate improved prodrug versions of FDA-approved
drugs in the high need areas of pain, ADHD and other central
nervous system disorders. KemPharm’s co-lead clinical development
candidates are KP415 and KP484, both based on a prodrug of
methylphenidate, but with differing extended-release profiles for
the treatment of ADHD, Apadaz™, an immediate-release,
abuse-deterrent acetaminophen/hydrocodone combination product
candidate and KP201/IR, an acetaminophen-free formulation of the
company’s immediate release abuse deterrent hydrocodone product
candidate, KP201. For more information on KemPharm and its
pipeline of prodrug product candidates visit www.kempharm.com.
About Genco
Genco is a privately held company developing proprietary
products for the treatment of ADHD and Tourette’s/Tics.
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. These forward-looking statements include
statements regarding the ability of KemPharm to develop any product
candidates under the terms of its license agreement with Genco, the
expected features and characteristics of any such product
candidate, and the potential for KemPharm to make any regulatory
filings with the FDA, including without limitation the ability of
KemPharm to seek any Priority Review voucher related thereto. These
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. Actual results
and performance could differ materially from those projected in the
forward-looking statements as a result of many factors, including,
without limitation, the risks and uncertainties associated with:
KemPharm's financial resources and whether they will be sufficient
to meet KemPharm's business objectives and operational
requirements; results of earlier studies and trials may not be
predictive of future clinical trial results; the protection and
market exclusivity provided by KemPharm's intellectual property;
risks related to the drug discovery and the regulatory approval
process; the impact of competitive products and technological
changes; and the FDA approval process under the Section 505(b)(2)
regulatory pathway, including without limitation any timelines for
related approval. KemPharm's forward-looking statements also
involve assumptions that, if they prove incorrect, would cause its
results to differ materially from those expressed or implied by
such forward-looking statements. These and other risks concerning
KemPharm’s business are described in additional detail in
KemPharm's Quarterly Report on Form 10-Q for the period ended June
30, 2017, 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.
Investor
Contacts: |
Media
Contact: |
Jason Rando / Joshua
Drumm, Ph.D.
Tiberend Strategic
Advisors, Inc.212-375-2665 /
2664jrando@tiberend.comjdrumm@tiberend.com |
Daniel L.
CohenExecutive VP, Government and Public RelationsKemPharm,
Inc.202-329-1825dcohen@kempharm.com |
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