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KemPharm Announces Additional Patent Protection for Prodrug Portfolio

US Patent and Trademark Office decision extends additional patent protection to KP201 and the KP511 compound family

CORALVILLE, Iowa, Feb. 23, 2017 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced 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 two new patents: 1) a “Composition of Matter” patent related to the KP511 family of compounds, and 2) a “Dosage and Formulation” patent protection related to KP201.

“These additional patents continue to strengthen our robust estate of intellectual property that underpins our entire prodrug product portfolio,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Our growing patent protection portfolio extends well into the early to mid-2030’s and exemplifies the potential of our prodrug discovery platform to address unmet medical needs in large, established markets by improving one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety.  We believe this protection period provides ample marketing time following the commercial development of our products, offering the potential of both an immediate and a sustained value proposition.”

KemPharm was recently issued U.S. Patent No. 9,566,343 from the USPTO for its patent application entitled “Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydromorphone, prodrugs, methods of making and use thereof.” The patent, which extends through 2032, provides composition of matter protection and adds to the intellectual property moat around KP511, KemPharm’s prodrug of hydromorphone. The patent has issued claims for the use of a specific hydromorphone prodrug to treat pain, as well as claims for decreased side effects and decreased potential for intra-nasal abuse when compared to an equivalent amount of unconjugated hydromorphone. 

The USPTO has also issued U.S. Patent No. 9,549,923, a dosage and formulation patent for a composition of KP201, KemPharm’s prodrug of hydrocodone. This patent also has claims to an abuse-deterrent formulation with lower hydrocodone exposure upon intra-nasal administration as compared to an equivalent dose of hydrocodone bitartrate.

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 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 disorders. KemPharm’s co-lead clinical development candidates are KP415, an extended-release prodrug of methylphenidate for the treatment of ADHD, and KP201/IR, an acetaminophen-free formulation of the company’s immediate release abuse deterrent hydrocodone product, 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 KP511 and KP201 and the sufficiency of KemPharm’s patent portfolio to maintain exclusivity over and protection for its product candidates.  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 KP415; 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 September 30, 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:
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

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