US Patent and Trademark Office issues patent protection to KP746, an investigational therapy for the
treatment of pain with a prodrug of oxymorphone
CORALVILLE, Iowa, June 26, 2017 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced a further enhancement
to KemPharm's U.S. and global intellectual property estate governing its portfolio of prodrug product candidates with the
addition of a patent for KP746, a prodrug of oxymorphone.
“This first patent for KP746 continues to build our strong patent estate of intellectual property that underpins our entire
prodrug product portfolio,” said Travis Mickle, Ph.D., KemPharm President and Chief Executive Officer. "We believe that KP746 could
be designated a New Molecular Entity, or NME, by the FDA. As a prodrug of oxymorphone, it is currently in preclinical
development for the potential treatment of moderate to severe acute and chronic pain. All of our growing patent estate is
predicated on allowing us ample time to commercially develop our products, offering the potential of both an immediate and a
sustained protected value proposition.”
KemPharm was recently issued U.S. Patent No. 9,682,076 from the United States Patent and Trademark Office (USPTO) for its patent
application entitled “Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of oxymorphone,
prodrugs, methods of making and use thereof.” The patent, which extends through 2035, provides compositions of matter
for treating moderate to severe pain, specifically comprising a compound and compositions of oxymorphone conjugated to
6-diflunisal.
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 LATTM (Ligand Activated Therapy) platform
technology. KemPharm utilizes its LATTM platform technology to generate improved prodrug versions of U.S. Food and
Drug Administration (FDA)-approved drugs in the high need areas of pain, attention deficit hyperactivity disorder (ADHD) and other
central nervous system (CNS) disorders. KemPharm’s co-lead clinical development candidates are KP415, an extended-release (ER)
prodrug of methylphenidate for the treatment of ADHD, and KP201/IR, an acetaminophen-free formulation of the company’s immediate
release (IR) abuse deterrent hydrocodone product candidate, KP201. For more information on KemPharm and its pipeline of
prodrug product candidates visit www.kempharm.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, 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
expected features and characteristics of KP746 and the anticipated scope of KemPharm’s intellectual property rights based on
development of its patent portfolio. 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; obligations
to third parties regarding the potential commercialization or sale of KP201/IR, KP415 or KP746; and the FDA approval process,
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 quarter ended March 31, 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: Jason Rando / Joshua Drumm, Ph.D. Tiberend Strategic Advisors, Inc. 212-375-2665 / 2664 jrando@tiberend.com jdrumm@tiberend.com Media Contact: Daniel L. Cohen Executive VP, Government and Public Relations KemPharm, Inc. 202-329-1825 dcohen@kempharm.com
