KemPharm Issues Letter to Shareholders

CELEBRATION, Fla., June 18, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that Travis C. Mickle, Ph.D., President and CEO of KemPharm, has issued a Letter to Shareholders in connection with the Company’s 2020 Annual Meeting of Stockholders to be held on June 19, 2020.  The letter provides an update on recent events and outlook for the remainder of 2020 and early 2021.

The full text of the letter follows below. 

A MESSAGE FROM OUR CHAIRMAN AND CHIEF EXECUTIVE OFFICER

Dear Fellow Shareholders:

The last twelve months have been a period of significant advancement for KemPharm.  While challenges certainly remain, there are also significant reasons for optimism.  Just recently, the New Drug Application (“NDA”) for KP415, our investigational product candidate for the treatment of attention deficit hyperactivity disorder (“ADHD”), was successfully filed and accepted by the U.S. Food and Drug Administration (“FDA”).  In addition, we recently received Day-74 Letter from the FDA which set the action date (“PDUFA”) for KP415 as March 2, 2021.  I am also pleased to pass along that there were no information requests included in the letter from the FDA that were not already expected, and the FDA informed us that an advisory committee is not required at this time. 

The FDA’s acceptance of the KP415 NDA has triggered two important developments in our collaboration with Gurnet Point Capital (“GPC”) and its affiliates.  First, KemPharm earned and has since received the $5 million milestone payment as provided by the definitive collaboration and license agreement we entered into with an affiliate of GPC on September 3, 2019 (the “KP415/KP484 License Agreement”).  Second, we were pleased to announce Corium, Inc. (“Corium”), a GPC portfolio company, will lead all commercialization activities for KP415.

Corium is led by several executives with significant experience in the commercialization of ADHD products, including its President and Chief Executive Officer, Perry Sternberg.  Mr. Sternberg previously served a dual role at Shire Plc (“Shire”) as the Head of U.S. Commercial for seven therapeutic area business units, as well as the Chief Commercial Officer/Head of the Neuroscience Division, prior to the acquisition of Shire by Takeda Pharmaceutical Corporation Limited.  During his tenure at Shire, Mr. Sternberg was responsible for bringing forth several groundbreaking ADHD products, including Vyvanse.