Kadmon Submits Second Abbreviated New Drug Application Filing For Trientine Hydrochloride To FDA

-- Product to Offer Room Temperature Storage, Representing Unique Advantage Over Currently Marketed Formulations --

NEW YORK--(BUSINESS WIRE)--Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”) today announced that on March 31, 2017, it submitted its second Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for KD034, the Company’s trientine hydrochloride formulation for the treatment of Wilson’s disease, a rare genetic liver disorder, for patients who are intolerant of penicillamine. The Company also submitted an ANDA for a bottled form of trientine hydrochloride in December 2016.

“We are pleased to submit our second ANDA for our trientine hydrochloride formulation offering room temperature storage, which, if approved, we believe will enhance patient convenience and optimize disease management”

This second ANDA is for Kadmon’s generic version of trientine hydrochloride in blister packaging that offers room temperature storage, which the Company believes has the potential to address shortcomings of currently available trientine hydrochloride formulations.

“We are pleased to submit our second ANDA for our trientine hydrochloride formulation offering room temperature storage, which, if approved, we believe will enhance patient convenience and optimize disease management,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “We remain committed to improving the lives of patients living with Wilson’s disease and look forward to providing updates on the FDA review process.”

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.

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