KemPharm Presents Clinical Data for Opioid Prodrug Candidates at American Academy of Pain Medicine’s Annual Meeting

Poster Presentations Highlight Oral Equivalency and Intranasal Abuse Deterrence Technology

CORALVILLE, Iowa, March 16, 2017 -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, presented clinical data from two of its opioid prodrug candidates, KP511, KemPharm’s prodrug of hydromorphone, and KP201/IR, KemPharm’s prodrug of hydrocodone, at the American Academy of Pain Medicine (AAPM) Annual Meeting, held March 15-19, 2017.

“The clinical findings we are presenting at AAPM for our opioid prodrugs demonstrate the potential of our Ligand Activated Therapy Prodrug Discovery Platform to improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We believe the ongoing clinical advancement of KP201/IR and KP511, as well as KP415, our extended-release prodrug of methylphenidate for the treatment of attention deficit hyperactivity disorder, are the forefront of our potential to apply our prodrug discovery platform to drug product development opportunities.”

The first poster, titled, “Oral pharmacokinetics of KP511, a prodrug of hydromorphone, relative to hydromorphone in human volunteers,” reports the results of a Phase 1 proof-of-concept study for KP511. 

In the study, KemPharm observed comparable hydromorphone exposure between 4 mg Dilaudid^TM Oral Liquid (hydromorphone HCl) and an equimolar 8 mg dose of KP511, as measured by AUC_last (90% CI: 83.1%-101.6%) and AUC_inf (90% CI: 83.7%-106.2%).  Peak exposure (C_max) was approximately 19% lower for KP511. Similar reductions of approximately 15% and 17%, respectively, in dose-adjusted peak hydromorphone exposure were observed for the 4 mg and 16 mg doses of KP511 with dose-linear C_max values across all three doses. Median time to peak exposure (T_max) was 0.5 hours for all treatments. Adverse events were also similar for KP511 and Dilaudid Oral Liquid and were typical for oral opioids.

The second poster, titled, “Pharmacokinetics and Abuse Potential of Benzhydrocodone, A Novel Prodrug of Hydrocodone, After Intranasal Administration in Recreational Drug Users,” reviews the findings of the KP201.A03 trial, which compared hydrocodone exposure following insufflation of KP201 vs. hydrocodone bitartrate (HB), as described previously at the PAINWEEK 2016 Annual Meeting.

In the trial, KemPharm observed peak hydrocodone plasma concentration (C_max) was 36.0% lower, and total hydrocodone exposures (AUC_last and AUC_inf) were 20.3% and 19.5% lower, respectively, for intranasal (IN) KP201 compared to IN HB (p<0.0001). Reductions in exposure were particularly apparent at early time points after dosing, with a ≥75% reduction in hydrocodone exposure for IN KP201 relative to IN HB at all time intervals up to one-hour post-dose.  Additionally, “Peak Drug Liking” score, as assessed by maximal liking (E_max), was lower for IN KP201 compared to IN HB (p=0.004), with approximately 45% of subjects showing ≥30% reduction in Peak Drug Liking E_max compared to HB.

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 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 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 KP201/IR, KP415 and KP511.  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 or KP511; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2016, 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]