CORALVILLE, Iowa, May 21, 2015 (GLOBE NEWSWIRE) -- KemPharm, Inc. (Nasdaq:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced today that the Company concluded a pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration ("FDA") for its lead pain candidate, KP201/APAP (benzhydrocodone hydrochloride and acetaminophen). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical and non-clinical requirements for the Company's NDA submission.
At the pre-NDA meeting, representatives from the FDA reviewed the Company's preliminary data package being prepared for the NDA submission, including clinical, non-clinical, regulatory and abuse liability elements. Based on the review, it was determined that the final package would be sufficient for submission of the NDA utilizing the 505(b)(2) pathway, with acceptance of the final NDA subject to the FDA's review of the complete package. In addition, the FDA has agreed to meet with the Company again in the near future to further discuss the details of the manufacturing requirements to be included with the NDA.
Travis C. Mickle, Ph.D., KemPharm's President and CEO, said, "We are pleased with the collaborative tone of our meeting with the FDA, and we've come away with a solid understanding of the Agency's requirements for our submission. Based on feedback received during this meeting and from previous correspondence, we are confident in moving forward with our NDA submission for KP201/APAP, which is on track for an anticipated filing in the second half of 2015."
Dr. Mickle continued, saying, "In the near-term, we look forward to completing the oral and intranasal human abuse liability clinical trials comparing KP201/APAP to Norco®, and analyzing the data to determine whether the information can increase the possibility of abuse-deterrent labeling for KP201/APAP."
KP201/APAP is an immediate release (IR) combination of KP201, KemPharm's prodrug of hydrocodone, and APAP (acetaminophen), which is being developed for the treatment of acute moderate to moderately severe pain. KP201/APAP is designed to be an abuse-deterrent opioid product that offers equivalent efficacy to the existing standard-of-care, IR hydrocodone/APAP combination products. KP201 combines hydrocodone with the ligand benzoic acid and is designed to deter tampering and abuse by selecting a molecular structure that prevents the release of the opioid upon crushing, physical manipulation and the application of other commonly employed extraction techniques.
About KemPharm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of 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, 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 are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to the Company 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: the Company's financial resources and whether they will be sufficient to meet the Company'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 the Company's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. The Company'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 the Company's Registration Statement on Form S-1 (Registration No. 333-202660) declared effective April 15, 2015, and the Company'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.
CONTACT: For KemPharm, Inc.:
Gordon K. "Rusty" Johnson
319-665-2575
info@kempharm.com
Media / Investor Contacts:
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com
