KemPharm Receives USAN Approval for “Asalhydromorphone” as Nonproprietary Name for Novel Prodrug Candidate, KP511

CORALVILLE, Iowa, Nov. 06, 2017 (GLOBE NEWSWIRE) -- KemPharm, Inc. a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the United States Adopted Name (USAN) Council approved the use of the nonproprietary name, “Asalhydromorphone (Asal-HM),” for use as the descriptor for the active pharmaceutical ingredient of its opioid-base pain treatment product candidate, KP511.

Asal-HM is a prodrug of hydromorphone being developed as a potentially less abusable hydromorphone product for the treatment of pain severe enough to require daily, long-term opioid treatment. Chemically, Asal-HM (KP511) is a conjugate of hydromorphone and two acetylsalicylic acid (aspirin) moieties. It is believed that the resulting conjugate may lead to a lower abuse potential than hydromorphone by itself.

“The designation of Asalhydromorphone as KP511’s nonproprietary name is an important step in the ongoing development of KP511,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Combined with our recent announcement of the data from our pharmacokinetic and pilot abuse potential study, KP511 A.01, the ongoing development of Asal-HM has continued to meet our announcement developmental milestones to date.”

“Through the assignment of this USAN, Asal-HM follows our benzhydrocodone/acetaminophen prodrug product, Apadaz™, as the second opiate product developed with our LAT™ prodrug platform to be granted an officially recognized new chemical structure,” Mickle added. “These distinctions are important as there is a clear requirement for a new class of opioids that provides the same therapeutic benefits as existing therapies, but with a significant reduction in the potential for abuse.”

About Asal-HM (KP511)

Asal-HM is KemPharm’s prodrug of hydromorphone, which is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate. KemPharm plans to develop Asal-HM to be an abuse-deterrent opioid product that offers equivalent safety and efficacy to approved hydromorphone products.

The Asal-HM prodrug combines hydromorphone with one or more ligands and can be formulated in both Immediate Release and Extended Release dosage forms. Asal-HM is designed not to release its hydromorphone component until it is metabolized in the gastrointestinal tract following oral administration. KemPharm believes Asal-HM is tamper-resistant and is chemically stable under conditions that can potentially be used to extract the active hydromorphone from many formulation-based abuse-deterrent technologies.

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 pain, attention deficit hyperactivity disorder 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 Asal-HM, and the ability of KemPharm to meet its developmental milestones for Asal-HM, including any regulatory filings with the U.S. Food and Drug Administration related thereto. 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 period ended June 30, 2017, 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.