Press release
KemPharm Announces Amendment to Licensing Agreement with Gurnet Point Capital Affiliate Following FDA Approval of AZSTARYS™
Amendment Increases Total Potential Regulatory and Sales Milestone Payments to $590 Million, and Adds a New Top-Level Tier for Royalties on U.S. Net Sales
About this update from Zevra Therapeutics, Inc.
[{"type":"text","content":"Amendment Increases Total Potential Regulatory and Sales Milestone Payments to $590 Million, and Adds a New Top-Level Tier for Royalties on U.S. Net Sales Conference Call and Live Audio Webcast Scheduled for Today, Thursday, April 8, at 4:30 p.m. ET CELEBRATION, Fla., April 08, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced an amendment to the definitive collaboration and license agreement (the License Agreement) with an affiliate of Gurnet Point Capital (GPC), a private investment firm focused on the life sciences and medical technology sectors. 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. Under the terms of the amended License Agreement, KemPharm is now 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. Royalty rates range, on a product-by-product basis, from a percentage in the high single digits up to the mid-twenties for U.S. net sales, and a percentage in the low to mid-single digits of net sales in each country outside of the U.S. Under the original terms of the License Agreement, KemPharm was eligible to receive up to $468 million in regulatory and sales milestones, having already received $15 million from previously achieved milestones. Per the amended terms, KemPharm will receive a regulatory milestone payment of $10 million for the FDA approval of AZSTARYS which is due five (5) calendar days after the effective date of the amendment. In addition, KemPharm is eligible to receive an additional regulatory milestone payment of $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 o...