KemPharm Completes Successful End-of-Phase II Meeting on KP415 With FDA

All Clinical and Non-Clinical Programs Remain on Track for ADHD Prodrug Candidate,
Pivotal Efficacy Trial to Study Duration of Therapy to Initiate Prior to Year-End

CORALVILLE, Iowa, Nov. 16, 2017 (GLOBE NEWSWIRE) -- KemPharm (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today reported the successful completion of an End-of-Phase 2 (EOP2) meeting with the FDA for KP415, the company’s extended release (ER) d-methylphenidate (d-MPH) prodrug product candidate designed for the treatment of Attention Deficit, Hyperactivity Disorder (ADHD). KemPharm held the EOP2 meeting with the FDA to discuss the status of the proposed clinical, non-clinical and abuse liability studies, as well as chemistry, manufacturing, and controls (CMC) programs required for eventual submission of a New Drug Application (NDA) for KP415.

“The successful completion of the KP415 End-of-Phase 2 meeting with the FDA is another positive step in our effort to bring KP415, our prodrug product candidate for the treatment of ADHD, to patients,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Based on the feedback from the FDA, KemPharm believes that the ongoing and anticipated research for KP415, including the single required pivotal efficacy trial to study duration of therapy planned for initiation prior to the end of this year, remains in alignment with a potential NDA submission as soon as the end of 2018.”

“The single ‘classroom-style’ pivotal efficacy trial is required to provide evidence for KP415 to support a potential labeled indication of both early onset of action and extended duration of therapy, both of which are unmet needs with current methylphenidate products,” added Mickle. “The meeting with the FDA helped confirm for us that we remain on schedule in the KP415 development program, including the work required to complete other standard protocols.”

KP415 – Prodrug of d-MPH for ADHD:

KP415 is KemPharm’s ER d-MPH prodrug product candidate designed for the treatment of ADHD. Based on the feedback from the FDA and the data from Phase 1 trials, KemPharm developed KP415 specifically for the broad needs of the ADHD population. KemPharm believes KP415 may also demonstrate a lower abuse potential as well as less variability in delivery of d-MPH compared to current methylphenidate products.

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 proprietary LAT^TM (Ligand Activated Therapy) platform technology. KemPharm utilizes its proprietary LAT^TM platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of ADHD, pain and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of methylphenidate, but with differing extended-release profiles for the treatment of ADHD. In addition, the company is advancing Apadaz™, an immediate-release, abuse-deterrent hydrocodone/acetaminophen combination product candidate, 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 any of KemPharm’s product candidates, including KP415, as well as the expected timing of the initiation and completion of any clinical trials for KP415 and the expected timing of any NDA submission for 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 Annual Report on Form 10-K for the 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.