KemPharm Receives $10M Milestone for FDA Approval of Azstarys

KemPharm Inc., a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, has confirmed receipt of a regulatory milestone payment of $10 million for the FDA approval of Azstarys in accordance with the recently amended definitive collaboration and license agreement with Commave Therapeutics, SA, an affiliate of Gurnet Point Capital.

The License Agreement provides for an exclusive worldwide license to develop, manufacture and commercialize KemPharm’s product candidates containing serdexmethylphenidate (SDX) and d-methylphenidate (d-MPH), including Azstarys (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. Azstarys was approved by the U.S. Food and Drug Administration (FDA) on March 2, 2021. As previously announced, Corium Inc., a portfolio company of Gurnet Point Capital, is leading U.S. commercialization efforts for Azstarys.

Corium is led by Perry Sternberg, president and CEO, who is a biotechnology and pharmaceutical industry leader with more than 25 years of commercial experience across a wide range of therapeutic areas in diverse markets. Prior to joining Corium, Sternberg 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, before the acquisition of Shire by Takeda Pharmaceutical Corporation Limited in early 2019.

Terms of the Agreement

Under the terms of the License Agreement and including the $10 million regulatory milestone payment just received, KemPharm is eligible to receive a total of up to $590 million in future regulatory and sales milestone payments for Azstarys, as well as tiered royalty payments on a product-by-product basis for net sales. The next regulatory milestone payment related to Azstarys is $10 million within thirty (30) days following the scheduling determination of SDX, the prodrug component of Azstarys, by the U.S. Drug Enforcement Administration (DEA). The DEA action is expected to be completed on or around June 2, 2021.

“We continue to work collaboratively with Corium in preparation for the commercial launch of Azstarys,” stated Travis C. Mickle, Ph.D., president and CEO of KemPharm. “Corium is targeting a product launch in the second half of 2021, and we believe the uptake for Azstarys could be substantial given the strong and differentiated product characteristics as reflected in the label which directly addresses key prescriber and patient needs not met by currently available methylphenidate treatments for ADHD.”

“The Corium team is deep in ADHD commercialization experience and excited about the FDA approval of Azstarys. Since approval, we have significantly ramped-up our commercialization activities to prepare for a successful launch,” said Perry Sternberg. “We have seen positive receptivity and reactions from customers due to the potential differentiation that Azstarys may provide for patients.”

Sternberg concluded, “We are energized and driving forward to optimize the commercial launch later this year.”