KemPharm Provides Update on Development Pipeline

IND for KP879 Expected to be Filed Before Year-End 2020; New Prodrug Candidate Added to Pipeline, Targeting Rare CNS Disease, Idiopathic Hypersomnia (IH)

CELEBRATION, Fla., Nov. 23, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today provided an update to its prodrug development pipeline, including the expected filing of the Investigational New Drug (IND) application for KP879 with the U.S. Food and Drug Administration (FDA) prior to year-end 2020, and the introduction of a new prodrug candidate to its pipeline, KP1077. KemPharm is investigating KP1077 as a potential treatment for idiopathic hypersomnia (IH), which is an underserved, orphan disease indication.

“Our primary focus during 2020 has been advancing KP415 into and through the NDA review process with the FDA, but it has not been our sole focus,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “While we believe KP415 has the potential to be a primary value driver for KemPharm in the near future, we continue to expand our pipeline with new growth opportunities for the Company. In this regard, we are pleased to announce the discovery of our newest prodrug candidate, KP1077, and the expected filing of the KP879 IND before year-end.”

KP1077 is KemPharm’s newly developed investigational product candidate for the treatment of IH, a neurological disorder marked by significant, detrimental effects on nighttime sleep as well as daytime sleepiness/wakefulness.

KemPharm is developing KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD).   KP879 utilizes serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH). There are currently no products in the market which are designed or approved to treat SUD.

Dr. Mickle continued, “We believe that both KP879 and KP1077 showcase several important future opportunities for KemPharm. First, these product candidates may allow us entry into orphan disease indications, which are underserved, and as a result, may qualify for both Fast-Track status and Orphan Drug designation from the FDA.   Second, each product candidate leverages our LAT approach, which we believe demonstrates the versatility of the technology, and, in the case of SDX, its unique ability to serve as a product platform.”