KMPH KemPharm Inc

KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced it will present data from two studies involving KP201, the company’s prodrug of hydrocodone (benzhydrocodone), at the PAINWeek 2016 Annual Meeting, September 6-10, 2016 in Las Vegas, Nevada.

The first poster to be presented, “Pharmacokinetics and abuse potential of benzhydrocodone, a novel prodrug of hydrocodone, after intranasal administration in recreational drug users,” (Abstract #0716, September 8, 2016, 6:30 – 8:30 pm) provides a review of the full data package from the KP201.A03 trial, which compared hydrocodone exposure following insufflation of KP201 vs. hydrocodone bitartrate (HB). 

In the trial, KemPharm observed that peak hydrocodone plasma concentration (Cmax) was 36.0% lower, and total hydrocodone exposures (AUClast and AUCinf) 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 (Emax), was lower for IN KP201 compared to IN HB (p=0.004), with approximately 45% of subjects showing ≥30% reduction in Peak Drug Liking Emax compared to HB.

The second poster presentation, “In vitro tampering assessment of the novel prodrug combination, benzhydrocodone/acetaminophen (Apadaz™), compared to hydrocodone/acetaminophen,” (Abstract #0733, September 8, 2016, 6:30 – 8:30 pm) provides an analysis of extraction studies designed to evaluate the tamper-resistant properties of Apadaz, KemPharm's prodrug of hydrocodone in combination with acetaminophen (APAP), compared to a generic HB/APAP product (HB/APAP).  Collectively, the data concluded that Apadaz provides physicochemical barriers that may make manipulation for IN and intravenous abuse inefficient and difficult compared to currently available IR hydrocodone combination products.

In large volume extraction experiments under non-stressing conditions, less than 5% of hydrocodone was released from Apadaz in 23 of 26 solvents. The maximum amount of hydrocodone that could be extracted was 37%, accomplished with an extremely acidic solvent after six hours. In contrast, 85% of hydrocodone could be extracted from HB/APAP with common ingestible solvents within 5 minutes.  In small volume extraction experiments, no hydrocodone was released above the limit of quantitation from Apadaz under any of the 164 test conditions, whereas all 164 conditions released hydrocodone from HB/APAP.

“As we advance KP201/IR, our immediate-release, acetaminophen-free formulation of KP201, toward an Investigational New Drug application filing, the studies presented during PAINWeek 2016 demonstrate properties of our hydrocodone prodrug that we believe illustrate the potential of this product candidate to deter misuse, diversion and abuse,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We are appreciative of the opportunity to present this data at PAINWeek and look forward to continuing the clinical development of KP201/IR.”

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 platform technology.  KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other CNS disorders.

Caution Concerning Forward Looking StatementsThis 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 and Apadaz™, and the expected timing of filing of an Investigational New Drug application for KP201/IR.  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; and the FDA approval process under the Section 505(b)(2) regulatory pathway, 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 June 30, 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
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