Agreement focused on KemPharm’s current and
in-development IR Opioid Pipeline
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs, and Acura Pharmaceuticals, Inc. (NASDAQ:ACUR)
today announced that they have entered into a License Agreement
(the "Agreement") whereby Acura will provide its proprietary
Aversion® Technology to KemPharm to use with its current and
in-development immediate release (IR) opioid product
candidates. Aversion® Technology is a patented composition of
commonly used active and inactive pharmaceutical ingredients
providing abuse deterrent features (ADF) and benefits for orally
administered pharmaceutical drug products.
The Agreement provided for an upfront cash
payment of $3.5 million to Acura at execution and grants KemPharm
development and commercialization rights for up to three IR product
candidates containing two of KemPharm’s opioid prodrugs.
Additional payments are provided in the Agreement should KemPharm
exercise its option to use Acura’s Aversion® Technology with more
than the three products. Acura is eligible to receive a royalty at
a low single-digit rate based on commercial sales by KemPharm of
all products developed under the Agreement. KemPharm will
solely own the intellectual property resulting from any new product
development.
“Acura’s Aversion® Technology, an FDA-approved
aversive ADF approach without a food effect, and KP201/IR, our
priority lead product candidate, together offer significant
potential benefits,” stated Travis C. Mickle, Ph.D., President and
Chief Executive Officer of KemPharm. “We believe today’s
Agreement will help us bridge the regulatory approval process
between current abuse deterrence products and the ability of our
new molecular entity prodrugs to demonstrate their ADF
properties.”
“Based on the strength of our existing data, as
well as what we view to be favorable developmental, regulatory and
market conditions, we expect this agreement with Acura to allow us
to bring a unique prodrug product with the addition of demonstrated
aversive barriers to the market in the near term,” Mickle
continued. “Access to this technology was contemplated in the
guidance for timelines we recently provided for KP201/IR.”
"We are excited to partner with KemPharm who,
like us, is committed to address the problem of prescription opioid
abuse,” said Bob Jones, President and CEO of Acura. “We
believe KemPharm shares our objective of aggressively developing
and bringing to the healthcare community new abuse deterrent IR
opioid analgesics to treat pain.”
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 Ligand Activated Therapy (LAT) platform technology.
KemPharm utilizes its LAT platform technology to generate improved
prodrug versions of FDA-approved drugs in the high need areas of
pain, ADHD and other CNS (central nervous system) disorders
About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty
pharmaceutical company engaged in the research, development and
commercialization of product candidates intended to address
medication abuse and misuse, utilizing its proprietary LIMITX™,
AVERSION® and IMPEDE® Technologies. LIMITX contains ingredients
that are intended to reduce or limit the rate or extent of opioid
release when multiple tablets are ingested. AVERSION contains
polymers that cause the drug to gel when dissolved; it also
contains compounds that irritate the nasal passages if the product
is snorted. IMPEDE is designed to disrupt the processing of
pseudoephedrine from tablets into methamphetamine. Acura
markets NEXAFED® and NEXAFED® Sinus, which are pseudoephedrine
containing products that utilize the IMPEDE Technology.
Caution Concerning Forward Looking
Statements
KemPharm’s 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
potential development of any product candidates under the
Agreement, the expected features and characteristics of KemPharm’s
current and in-development opioid product candidates, including
those potentially developed under the Agreement, and the related
development timelines for KP201/IR. 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, 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 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 quarter ended June
30, 2016, 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.
Acura’s Forward Looking
Statements
Certain statements in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors which may cause Acura’s actual results, performance or
achievements to be materially different from any future results,
performance, or achievements expressed or implied by such
forward-looking statements. Forward-looking statements may include,
but are not limited to:
- Acura’s ability to fund or obtain funding for its continuing
operations, including the development of its products utilizing our
LimitxTM and Impede® technologies;
- whether the extent to which products formulated with the
Aversion® technology deter abuse or will be determined sufficient
by the FDA to support approval or labeling describing abuse
deterrent features;
- Acura’s and its licensee's ability to obtain necessary
regulatory approvals, successfully launch and commercialize
products utilizing its technologies;
- the market acceptance of, timing of commercial launch and
competitive environment for any of Acura’s products or products
utilizing its technologies;
- Acura’s exposure to product liability and other lawsuits in
connection with the commercialization of products utilizing its
technologies;
- the ability to avoid infringement of patents, trademarks and
other proprietary rights of third parties;
- the ability of Acura’s patents to protect its products from
generic competition and its ability to protect and enforce its
patent rights in any paragraph IV patent infringement
litigation;
- the ability to fulfill the FDA requirements for approving
Acura’s product candidates or products utilizing its technologies
for commercial manufacturing and distribution in the United States,
including, without limitation, the adequacy of the results of the
laboratory and clinical studies completed to date, the results of
laboratory and clinical studies we may complete in the future to
support FDA approval of its product candidates and the sufficiency
of its development process to meet over-the-counter ("OTC")
Monograph standards, as applicable;
- changes in regulatory requirements;
- adverse safety findings relating to Acura’s commercialized
products or product candidates in development;
- whether the FDA will agree with Acura’s analysis of its
clinical and laboratory studies;
- whether further studies of Acura’s product candidates will be
required to support FDA approval;
- whether or when Acura is able to obtain FDA approval of
labeling for its product candidates for the proposed indications
and will be able to promote the features of its abuse discouraging
technologies; and
In some cases, you can identify forward-looking statements by
terms such as "may," "will," "should," "could," "would," "expects,"
"plans," "anticipates," "believes," "indicates," "estimates,"
"projects," "predicts," "potential" and similar expressions
intended to identify forward-looking statements. These statements
reflect Acura’s current views with respect to future events and are
based on assumptions and subject to risks and uncertainties. Given
these uncertainties, you should not place undue reliance on these
forward-looking statements. Many of these risks are discussed in
greater detail in Acura’s filings with the Securities and Exchange
Commission. Unless required by law, Acura undertakes no obligation
to update or revise any forward-looking statements to reflect new
information or future events or developments. Accordingly, you
should not assume that Acura’s silence over time means that actual
events are bearing out as expressed or implied in such
forward-looking statements.
For KemPharm, Inc.
Investors:
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com
Media:
Daniel L. Cohen
Executive VP, Government and Public Relations
KemPharm, Inc.
202-329-1825
dcohen@kempharm.com
For Acura Pharmaceuticals, Inc.
Investors/Media:
investors@acurapharm.com
847-705-7709
Acura Pharmaceuticals (CE) (USOTC:ACUR)
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