KemPharm Earns $1.975 Million From Corium Following FDA Approval of Donepezil Transdermal System
KemPharm, Inc. recently announced it has earned a $1.975 million fee from Corium, Inc. following the approval of Corium’s product ADLARITY (donepezil transdermal system) by the US FDA on March 11, 2022. ADLARITY is an innovative new treatment option for patients with mild, moderate, or severe dementia of the Alzheimer’s type.
KemPharm is due to receive the fee, within 30 calendar days following FDA approval of ADLARITY, pursuant to a master development services agreement entered into with Corium in July 2020, under which KemPharm provided development and regulatory assistance related to Corium’s resubmission of its New Drug Application for ADLARITY.
“We are pleased to have been able to assist Corium in obtaining FDA approval of ADLARITY, and we congratulate them on this significant achievement,” said Travis C. Mickle, PhD, President and CEO of KemPharm. “Looking forward, we expect to file our IND for KP1077 in the second quarter of this year as we continue to pursue our strategy of building a growing pipeline of product candidates for the treatment of sleep disorders and other orphan/rare diseases in CNS-related therapeutic areas.”
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) platform technology. KemPharm utilizes its proprietary LAT platform 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 idiopathic hypersomnia (IH) and other CNS/rare diseases. In addition, the US FDA has approved AZSTARYS, a once-daily treatment for ADHD in patents age 6 years and older, which is being commercialized by Corium, Inc. in the US, containing KemPharm’s prodrug, serdexmethylphenidate (SDX), and APADAZ, an immediate-release combination product containing benzhydrocodone, KemPharm’s prodrug of hydrocodone, and acetaminophen, which is being commercialized by KVK-Tech, Inc. in the US. For more information, visit www.kempharm.com.
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