News Release

KemPharm® is a clinical stage, specialty pharmaceutical company engaged in the development and discovery of proprietary prodrugs that are designed to be improved versions of widely prescribed and FDA approved products.

KemPharm Receives Patent Grant for KP606, a Prodrug of Oxycodone

January 23, 2018 at 7:30 AM EST

Additional Patent Granted for the KP511-related family, a Prodrug of Hydromorphone

CORALVILLE, Iowa, Jan. 23, 2018 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today further enhancements to KemPharm's U.S. and global intellectual property estate governing its portfolio of prodrug product candidates with the receipt of an initial patent issued for KP606, an oxycodone prodrug, as well as an additional composition of matter patent to enhance the existing family of patents related to KP511, a prodrug of hydromorphone.

“This first patent for KP606 continues to strengthen our patent estate of intellectual property which underpins our prodrug product candidate portfolio,” said Travis Mickle, Ph.D., KemPharm President and Chief Executive Officer. "KP606 is a New Molecular Entity, or NME, prodrug of oxycodone, which is currently in preclinical development for the potential treatment of moderate to severe acute and chronic pain.  Our growing patent estate is predicated on allowing us ample time to commercially develop our product candidates, which we believe offers the potential of both an immediate and a sustained protected value proposition.”

KemPharm was recently issued U.S. Patent No. 9,850,252 from the United States Patent and Trademark Office (USPTO) for its patent application related to KP606 entitled “Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of oxycodone, prodrugs, methods of making and use thereof.”  The patent, which extends through 2035, provides a compound, and compositions thereof, of oxycodone conjugated to 6-ibuprofen.

In addition, KemPharm was also recently issued U.S. Patent 9,849,185 for its patent application in the KP511-related family of patents. The patent, entitled "Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydromorphone, prodrugs, methods of making and use thereof." provides a compound, and compositions thereof, of 3-benzoate-hydromorphone.

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 ADHD, pain 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/effect profiles for the treatment of ADHD.  In addition, the company is advancing Apadaz™, an immediate-release combination product candidate of benzhydrocodone, a prodrug of hydrocodone, and acetaminophen, as well as KP201/IR, an acetaminophen-free immediate-release formulation of the company’s benzhydrocodone prodrug candidate. Both Apadaz™ and KP201/IR are designed to deter abuse and intended for the treatment of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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. 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. Risks concerning KemPharm’s business are described in detail in KemPharm's Annual Report on Form 10-K for the year ended December 31, 2016, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange CommissionKemPharm 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 / 2664
jrando@tiberend.com
jdrumm@tiberend.com
Daniel L. Cohen
Executive VP, Government and Public Relations
KemPharm, Inc.
202-329-1825
dcohen@kempharm.com

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Source: KemPharm