KemPharm Files IND for KP879 for the Treatment of Stimulant Use Disorder

KemPharm Files IND for KP879 for the Treatment of Stimulant Use Disorder

Celebration, FL – December 22, 2020 – KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin human clinical trials of KP879.  KemPharm is developing KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD).

If the KP879 IND filing is accepted by the FDA, KemPharm intends to initiate efficacy studies of KP879 in 2021.  It is anticipated that certain data from previously completed KP415 research may be leveraged for KP879, including pharmacokinetic studies, which KemPharm believes could potentially streamline the development timeline of KP879.  KP879 utilizes serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH).  SDX is also the primary active pharmaceutical ingredient (API) of KP415 and KP484, the company’s product candidates which are intended for the treatment of attention-deficit/hyperactivity disorder (ADHD).

“Filing the IND with the FDA for KP879 is an important step in the ongoing development of what could potentially be the first FDA-approved pharmacotherapy for SUD,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Additionally, we believe that KP879 represents an important development opportunity as it may demonstrate the potential for SDX, our prodrug of d-MPH, to address indications beyond ADHD, while also highlighting the ability of our LAT^® technology to identify new prodrug products that address unmet needs in both large and other underserved markets.”

A New Drug Application for KP415 is currently under review with the FDA with an anticipated PDUFA date of March 2, 2021. KemPharm believes that the ability to develop multiple prodrug products from the same API with unique treatment benefits and commercial profiles is an important attribute of its Ligand Activated Therapy (LAT^®) prodrug technology.

Per the definitive collaboration and license agreement with an affiliate of Gurnet Point Capital (GPC), GPC holds an option to in-license KP879, in addition to certain other KemPharm pipeline programs.

About Stimulant Use Disorder (SUD):

Stimulant Use Disorders include those marked by abuse/misuse of cocaine, methamphetamines, prescription stimulant products that contain methylphenidate or amphetamine, and numerous designer stimulants including, for example, 3,4-methylenedioxypyrovalerone (MDPV) and 4-methylmethcathinone (mephedrone) (“bath salts”). According to the Substance Abuse and Mental Health Services Administration (SAMHSA), in 2016, among Americans older than 12 years, there were approximately 1.9 million current users of cocaine, 667,000 users of methamphetamine, and 1.7 million current misusers of prescription stimulants.  To date, there are no FDA-approved medications for the treatment of SUD.

About KemPharm:

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT^® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT^® technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder. KemPharm’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, KemPharm has received FDA approval for APADAZ^®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.

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, including without limitation KemPharm’s proposed development and commercial timelines, 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.  Forward-looking statements are not guarantees of future actions or performance.  These forward-looking statements, including the timing and probability of potential FDA approval of the KP415 NDA, acceptance of the KP879 IND, the timing of potential initiation of efficacy studies for KP879, and the potential clinical benefits of KP879, or any of KemPharm’s other product candidates.  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. Risks concerning KemPharm’s business are described in detail in KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, 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.

KemPharm Contacts:

Jason Rando/Maureen McEnroe

Tiberend Strategic Advisors, Inc.

(212) 375-2665 / 2664

[email protected]

[email protected]