KemPharm Announces First Patent Grant for KP746, a Prodrug of Oxymorphone

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 -- 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 LAT^TM (Ligand Activated Therapy) platform technology.  KemPharm utilizes its LAT^TM 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
[email protected]
[email protected]

Media Contact:
Daniel L. Cohen
Executive VP, Government and Public Relations
KemPharm, Inc.
202-329-1825
[email protected]