Patents Extend Across KemPharm’s Prodrug Portfolio, Including IP Protection for KP415 in Canada, Japan and Korea

CELEBRATION, Fla., Jan. 29, 2019 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced continued enhancements to its U.S. and global intellectual property estate governing its portfolio of prodrug product candidates.  The United States Patent and Trademark Office (USPTO) issued seven (7) new patents to KemPharm during 2018 related to several of its compound families, including KP201, KP303, KP511, KP606 and KP746. In addition, KemPharm has augmented and strengthened the global patent estate for KP415 with the addition of issued patents last year in Canada, Japan and Korea.

“These newly-issued patents serve to further fortify our robust intellectual property estate which protects our portfolio of prodrug product candidates,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Our growing IP portfolio in the ADHD, CNS and pain treatment spaces extends into the early to mid-2030’s.  We believe this protection period provides ample marketing time following the clinical development of our products, offering the potential for a sustained value proposition.”

In 2018, KemPharm was issued its first KP415-related patent in Canada (CA Patent 2837732), which provides composition of matter protection for methylphenidate prodrugs in the KP415 family, as well as additional patents in Japan and Korea, providing further composition of matter and method of use protection. Altogether, KemPharm now has patent protection for the KP415 family in more than 50 countries worldwide, including the U.S.

In the KP201 family, KemPharm was issued U.S. Patent No. 9,872,915 by the USPTO with method of use claims for a composition of benzoate-hydrocodone hydrochloride and acetaminophen. The patent adds to the intellectual property of benzhydrocodone, KemPharm’s prodrug of hydrocodone, as well as APADAZ^®, KemPharm’s FDA-approved immediate-release combination product containing benzhydrocodone and acetaminophen.

In the KP303 family, KemPharm was issued 3 U.S. patents (US 10,010,615, 9,889,198 and 9,890,150) providing composition of matter protection for several quetiapine prodrugs, as well as formulation and dosage claims.

In the KP511 family, the USPTO issued U.S. Patent 10,064,956, which provides composition of matter protection and adds to the intellectual property related to KP511, KemPharm’s prodrug of hydromorphone. This patent also includes formulation and dosage form claims.

In the KP606 family, KemPharm was recently issued U.S. Patent 10,144,740 which provides composition of matter protection for a specific prodrug of oxycodone. Additionally, the patent includes claims for methods of pain treatment, dosages, reduced side effects, and lower abuse potential.

Finally, in the KP746 family, the USPTO issued U.S. Patent 10,071,091, which provides composition of matter protection reinforcing the intellectual property related to KP746, KemPharm’s prodrug of oxymorphone. The patent also has claims for methods of treating pain, dosages, reduced side effects, and lower abuse potential.

About KemPharm:

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT^TM (Ligand Activated Therapy) technology.  KemPharm utilizes its proprietary LAT technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications.  KemPharm’s product pipeline is focused on the high need areas of ADHD, pain and other central nervous system disorders.  KemPharm’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles.  In addition, KemPharm has received FDA approval for APADAZ^®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.  For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.

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, 2017, KemPharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, 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.