KemPharm Completes Key Regulatory Meetings with FDA for KP201/IR and KP415

CORALVILLE, Iowa, July 14, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced the completion of milestone meetings with the U.S. Food and Drug Administration (FDA) for KP201/IR, the company’s single-entity, benzhydrocodone HCl immediate-release, abuse-deterrent product candidate designed for the treatment of acute pain, and KP415, the company’s prodrug of d-threo-methylphenidate for the treatment of attention deficit hyperactivity disorder (ADHD).

The meetings with the FDA consisted of an End-of-Phase 1 (EOP1) review for KP201/IR and a Pre-Investigational New Drug (Pre-IND) review for KP415. The meetings were held to obtain input from the Agency on KemPharm’s proposed clinical and nonclinical programs required for eventual submission of New Drug Applications (NDA) for both product candidates. KemPharm requested an EOP1 review for KP201/IR ahead of an anticipated IND submission based on the amount of data, both nonclinical and clinical, generated from the development of its combination product candidate, benzhydrocodone HCl and acetaminophen. The Pre-IND meeting for KP415 was the company’s first formal discussion with the Agency regarding this product candidate.

Based on input received from the FDA as a result of these two regulatory meetings, KemPharm expects to file investigational new drug applications (INDs) for both KP201/IR and KP415 during the second half of 2016.

“KP201/IR and KP415 are key product candidates in KemPharm’s clinical development pipeline, and we believe represent significant opportunities for the company to address important medical needs, while serving to demonstrate the strength and versatility of our Ligand Activated Therapy (LAT) prodrug platform,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Following the Phase 1 results from our KP511 program, the completion of these regulatory milestones adds to the momentum that continues to build behind our rapidly advancing pipeline.”

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 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 and KP415, the expected timing of filing of INDs for KP201/IR and KP415, and potential submissions of NDAs for KP201/IR and KP415. 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 March 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 Media Contact: Jim Heins Cooney Waters Unlimited 212-886-2221