KemPharm, Inc. (NASDAQ:KMPH) Files An 8-K

KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, and Acura Pharmaceuticals, Inc. (NASDAQ:ACUR) today announced that they have entered into a License Agreement (the “Agreement”) whereby Acura will provide its proprietary Aversion® Technology to KemPharm to use with its current and in-development immediate release (IR) opioid product candidates. Aversion® Technology is a patented composition of commonly used active and inactive pharmaceutical ingredients providing abuse deterrent features (ADF) and benefits for orally administered pharmaceutical drug products.

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The Agreement provided for an upfront cash payment of $3.5 million to Acura at execution and grants KemPharm development and commercialization rights for up to three IR product candidates containing two of KemPharm’s opioid prodrugs. Additional payments are provided in the Agreement should KemPharm exercise its option to use Acura’s Aversion® Technology with more than the three products. Acura is eligible to receive a royalty at a low single-digit rate based on commercial sales by KemPharm of all products developed under the Agreement. KemPharm will solely own the intellectual property resulting from any new product development.

“Acura’s Aversion® Technology, an FDA-approved aversive ADF approach without a food effect, and KP201/IR, our priority lead product candidate, together offer significant potential benefits,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We believe today’s Agreement will help us bridge the regulatory approval process between current abuse deterrence products and the ability of our new molecular entity prodrugs to demonstrate their ADF properties.”

“Based on the strength of our existing data, as well as what we view to be favorable developmental, regulatory and market conditions, we expect this agreement with Acura to allow us to bring a unique prodrug product with the addition of demonstrated aversive barriers to the market in the near term,” Mickle continued. “Access to this technology was contemplated in the guidance for timelines we recently provided for KP201/IR.”

“We are excited to partner with KemPharm who, like us, is committed to address the problem of prescription opioid abuse,” said Bob Jones, President and CEO of Acura. “We believe KemPharm shares our objective of aggressively developing and bringing to the healthcare community new abuse deterrent IR opioid analgesics to treat pain.”

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 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 (central nervous system) disorders

About Acura Pharmaceuticals

Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX™, AVERSION® and IMPEDE® Technologies. LIMITX contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine. Acura markets NEXAFED® and NEXAFED® Sinus, which are pseudoephedrine containing products that utilize the IMPEDE Technology.

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