KemPharm Expands Its Abuse-Deterrent Opioid Pipeline With New Acetaminophen-Free, Immediate Release Hydrocodone and Immediate Release Oxycodone Prodrug Product Candidates

KemPharm, Inc. KMPH, a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced today that KemPharm has initiated the development of an acetaminophen (APAP)-free formulation of its immediate release (IR) hydrocodone product, KP201, adding to its hydrocodone prodrug pipeline of product candidates. KemPharm expects this highly differentiated product candidate to feature the same abuse-deterrent properties demonstrated by KP201/APAP, KemPharm's most advanced product candidate, in the most recent clinical trial, KP201.A03. In addition, the Company announced it has initiated the development of an IR formulation of its oxycodone prodrug, KP606. Product Development Strategy 　 Parent Drug Product Candidate Status Anticipated NDA Filing Pain Hydrocodone (IR) KP201/APAP Clinical NDA-Filing Q4 2015 Hydrocodone (IR) KP201/IR (APAP-free) Clinical NDA-Filing 2017 Hydromorphone (ER) KP511/ER Preclinical NDA-Filing 2018 Oxycodone (IR) KP606/IR Preclinical NDA-Filing 2019 ADHD Methylphenidate (CR) KP415 Preclinical NDA-Filing 2019 Based on current development timelines, KemPharm anticipates a potential New Drug Application (NDA) filing for acetaminophen-free KP201 in 2017. KP201/IR would be the first IR, acetaminophen-free hydrocodone option available to physicians. In response to the favorable oral exposure data from the KP201.A01 trial, KemPharm is also preparing additional high strengths of both KP201/APAP and KP201/IR (APAP-free) to provide physicians additional flexibility and choices for pain management. These programs add to KemPharm's pipeline of opioid prodrug product candidates, which includes KP511/ER, an extended release (ER) formulation of its prodrug of hydromorphone, and KP606/IR, a new IR formulation of the Company's prodrug of oxycodone. In addition, KemPharm is developing KP415, a prodrug of methylphenidate with controlled release (CR) features, for managing ADHD. KemPharm continues to build a pipeline of discovery stage candidates and expects additional preclinical candidates to be announced by year-end. Travis C. Mickle, Ph.D., President and CEO of KemPharm, stated, "Adding acetaminophen-free KP201 to our pipeline represents a significant opportunity to extend our hydrocodone prodrug pipeline of product candidates and could potentially provide patients and physicians with a prescription opioid product that is currently not available. Further, we expect to rapidly develop KP201/IR (APAP-free), which could highlight the value of our LAT prodrug technology, specifically as it relates to the speed with which we may be able to advance our multiple product candidates from early- to late stage clinical development. Beginning with KP201/IR (APAP-free) as early as 2017, we anticipate filing at least one new NDA each year through 2019, potentially bringing multiple highly differentiated and potentially safer products to the market over the next several years." Dr. Mickle concluded, "The Company understands the importance of immediate release products in the treatment of pain and believes that creating abuse deterrent and safer IR products is important for prescribers and patients. The addition of KP201/IR (APAP-free) and our IR oxycodone prodrug, KP606/IR, highlights KemPharm's focus and progress in this important area."