Event Held Today, October 11, 2018
CORALVILLE, Iowa, Oct. 11, 2018 — KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today provided highlights from its investor event featuring a discussion with key opinion leaders (KOLs) and prescribing physicians in the field of Attention Deficit Hyperactivity Disorder (ADHD). The event was held in New York, NY, on Thursday, October 11, 2018.
The KemPharm ADHD Investor Event was organized to provide investors with a comprehensive review of the dynamics influencing the ADHD treatment landscape, including current challenges and unmet medical needs, as well as an overview of KemPharm’s ADHD prodrug portfolio, which is highlighted by its two lead investigational prodrug candidates for treating ADHD, KP415 and KP484.
Keynote speakers included Ann Childress, MD, President of the Center for Psychiatry & Behavioral Medicine in Las Vegas and Adjunct Faculty Member at the University of Nevada School of Medicine; Matthew Brams, MD, Medical Director and Principal, Bayou City Research, and Clinical Associate Professor of Psychiatry at the Baylor College of Medicine; and Timothy E. Wilens, MD, Chief, Division of Child and Adolescent Psychiatry and Co-Director, Center for Addiction Medicine at the Massachusetts General Hospital, and Associate Professor of Psychiatry at Harvard Medical School in Boston.
“We are very honored to have had the opportunity to conduct an ADHD Investor Event featuring such an esteemed panel of experts in ADHD treatment,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “As we advance KP415 towards a first quarter 2019 New Drug Application (NDA), we are continually reminded of the myriad dynamics impacting the ADHD space and the desire among prescribers and patients for therapeutic options that better address key unmet medical needs, including early onset of action, duration of therapy and lower abuse potential. On behalf of KemPharm, I would like to personally thank Drs. Childress, Brams and Wilens for discussing these important opportunities and where next-generation ADHD therapies, such as KP415 and KP484, could help to improve the lives of ADHD patients and their caregivers.”
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The full webcast and presentation slides from the KOL Investor Event can be accessed via the Investor Relations section under “Events & Presentations” on the KemPharm’s website at http://investors.kempharm.com.
The following is a recap of key presentations from the event:
ADHD Treatment Landscape and Using the Laboratory Classroom to Determine Drug Effects Led by Ann Childress, MD, the first presentation provided a review of the ADHD patient and treatment landscape, including key benefits and drawbacks of current ADHD medications and potential opportunities for improvement as developers seek to bring new products to market. Additionally, Dr. Childress focused on the design and execution of an ADHD classroom-style clinical study and measures that are used for determining efficacy. Included in Dr. Childress’ presentation was a discussion of the SKAMP and PERMP tests and the data that each is designed to provide, as well as examples and impressions from the KP415.E01 efficacy study.
Prescribing ADHD Medications in a Large Outpatient Practice: The Good, The Bad, and the Ugly In the next presentation, Matthew Brams, MD, discussed in detail the current ADHD treatment market and the advantages and disadvantages of generic and branded medications. Importantly, Dr. Brams highlighted key unmet needs that he believes must be addressed by next-generation ADHD products in order for those products to succeed. Unmet medical needs include faster onset, longer duration, improved tolerability and once-daily dosing.
Nonmedical Use of Prescription Stimulants In the final KOL presentation, Timothy E. Wilens, MD, discussed the prevalence of stimulant misuse, particularly the abuse of ADHD medications by college-age individuals. In his remarks, Dr. Wilens noted that amphetamines are the most common stimulant misused and that the oral and intranasal routes are preferred by misusers, highlighting the need for next-generation ADHD medications that reduce the potential of abuse.
KemPharm – ADHD Prodrug Portfolio and Corporate Update Concluding the ADHD Investor Event, Travis Mickle, Ph.D., reviewed the latest developments and anticipated milestones involving KP415 and KP484, KemPharm’s co-lead clinical development candidates for the treatment of ADHD. Dr. Mickle re-affirmed that KemPharm expects to file the NDA for KP415 in the first quarter of 2019, while the NDA submission for KP484 is expected to follow later in 2019. Additionally, Dr. Mickle discussed the ongoing strategic partnering discussions involving KP415 and KP484 and provided an update on the recently completed $25 million follow-on offering.
KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LATTM (Ligand Activated Therapy) platform technology. KemPharm utilizes its proprietary LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of ADHD, pain and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of d-methylphenidate, but with differing extended-release/effect profiles for the treatment of ADHD. 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, 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 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, filed with the Securities and Exchange Commission (SEC) on August 10, 2018, and KemPharm’s other Periodic and Current Reports filed with the SEC. 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.