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.

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savings and other benefits from our efforts to streamline our operations
and to not harm our business with such efforts. More detailed
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Section 13 of the Securities Exchange Act of 1934, as amended, with the
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