Kadmon Submits Abbreviated New Drug Application Filing for Trientine Hydrochloride to FDA

December 05, 2016

Kadmon Submits Abbreviated New Drug Application Filing for Trientine Hydrochloride to FDA

NEW YORK--(BUSINESS WIRE)-- Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”) today announced that it has submitted an Abbreviated New Drug Application (ANDA) for KD034, to the U.S. Food and Drug Administration (FDA). This is the first application submitted to the FDA by any company for a generic trientine hydrochloride product for the treatment of Wilson’s disease in patients who are intolerant of penicillamine. Wilson’s disease is a genetic liver disease characterized by an inability to excrete copper, causing severe hepatic, neurologic, psychiatric and ophthalmic abnormalities.

“Trientine hydrochloride is an important therapeutic option for Wilson’s disease patients, based on its tolerability profile, particularly for newly diagnosed and pediatric populations,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “We believe it is important to expand access to this treatment with additional options such as KD034.”

“This ANDA filing is a key milestone that highlights our commitment to developing therapies for rare diseases,” continued Dr. Waksal. “If approved, our entry into Wilson’s disease will be supported by broad disease education tools, with a focus on disease awareness, diagnosis and prompt patient management.”

About Kadmon Holdings, Inc.

Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company focused on developing innovative products for significant unmet medical needs. We have a diversified product pipeline in oncology, autoimmune and fibrotic diseases and genetic diseases.

Safe Harbor Statement

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For Kadmon Holdings, Inc.:
Investor Relations
Ellen Tremaine, 646-490-2989
ellen.tremaine@kadmon.com
or
Maeve Conneighton, 212-600-1902
maeve@argotpartners.com

Source: Kadmon Holdings, Inc.