CORALVILLE, Iowa, March 24, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration (FDA) has granted a fee waiver and has refunded the full user fee amount of $2,374,200 for its New Drug Application (NDA) filing for KP201/APAP, the Company’s investigational immediate release combination of its hydrocodone prodrug, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP), which is currently under priority review by the FDA. The FDA has set a target action date under the Prescription Drug User Fee Act of June 9, 2016.
The fee waiver, which KemPharm requested in accordance with section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act, is granted to a small business, as defined by the Small Business Administration, for the first human drug application submitted to the FDA for review.
Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm, commented, “We are pleased to receive this NDA fee waiver for KP201/APAP and look forward to continuing to work with the FDA through the review process. We believe that prodrugs developed using our Ligand-Activated Therapy technology may demonstrate properties that are aligned with the advice of regulatory, physician and patient organizations advocating for responsible measures for managing pain and prescribing opioids, including recommendations that opioid therapy for chronic pain begin with the introduction of immediate-release opioids as a means to reduce the risks associated with long-acting or extended-release opioids.”
KemPharm developed KP201/APAP using the Company’s proprietary Ligand-Activated Technology (LAT), which creates a new prodrug by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. Once administered, human metabolic processes, such as those in the gastrointestinal tract, separate the ligand from the prodrug and release the active parent drug, which can then provide its therapeutic effect.
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 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 21 E 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 timing of approval, if at all, of KP201/APAP by the FDA. 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; and the impact of competitive products and technological changes. 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, 2015, 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.