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Kadmon Announces FDA Approval of CLOVIQUE (TM), A Room-Temperature Stable Trientine Hydrochloride Product

Product Offers Room Temperature Stability, Improving Convenience for Patients

NEW YORK, NY / ACCESSWIRE / October 21, 2019 / Kadmon Holdings, Inc. (KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved CLOVIQUE™ (Trientine Hydrochloride Capsules, USP), a room-temperature stable, branded generic product. Trientine hydrochloride is used for the treatment of Wilson's disease in patients who are intolerant of penicillamine.

CLOVIQUE is the first FDA-approved trientine product in a portable blister pack that offers room temperature stability for up to 30 days, potentially providing patients more convenience. In a recently published survey, approximately 30% of Wilson's disease patients cited product storage as a medication-associated inconvenience of disease management.1

"CLOVIQUE is an innovative treatment option that can be stored at room temperature, which is an added convenience for Wilson's disease patients," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We are pleased to offer CLOVIQUE to patients in need as part of our goal to develop novel therapies for chronic, rare diseases."

Kadmon has immediately commenced commercialization activities for CLOVIQUE through Kadmon Pharmaceuticals, its wholly-owned commercial operation.

In September 2019, the FDA approved Kadmon's generic Trientine Hydrochloride Capsules USP, 250 mg, available in 100-count bottles. The FDA had determined Kadmon's Trientine Hydrochloride Capsules to be bioequivalent and therapeutically equivalent to the reference listed drug, Syprine® Capsules, 250 mg.

About Wilson's Disease

Wilson's disease is a rare genetic disorder causing excess copper accumulation in the body that results in neurological and metabolic adverse events.

About Kadmon

Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.

IMPORTANT SAFETY INFORMATION

Wilson's disease (WD), the most common inherited disorder of copper metabolism, results from a failure of the copper excretory pathway. This leads to toxic accumulation of copper in the liver and eventually other organs.2 The worldwide prevalence of WD is estimated to be one in 30,000 individuals.3

The condition can be treated with a low copper diet and the use of chelating agents that bind copper to facilitate its excretion from the body. CLOVIQUE™ (trientine hydrochloride) is a chelating agent indicated for treatment of patients with WD who are intolerant of the first-line treatment, penicillamine.4

Indications and Usage

CLOVIQUE™ may be used to treat Wilson's disease in patients who cannot take the medication penicillamine.

Clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. CLOVIQUE™ and penicillamine cannot be considered interchangeable. CLOVIQUE™ should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.

Unlike penicillamine, CLOVIQUE™ is not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.

CLOVIQUE™ is not indicated for treatment of biliary cirrhosis.

Important Safety Information

  • CLOVIQUE™ is contraindicated in patients hypersensitive to CLOVIQUE™ or any components of the formulation. Patients should be observed closely for signs of possible hypersensitivity.
  • Patients receiving CLOVIQUE™ should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia.
  • The treatment can be monitored by the determination of free copper in the serum. Therapy may be monitored with a 24-hour urinary copper analysis periodically (i.e., every 6-12 months).
  • CLOVIQUE™ contains a color additive FD&C Yellow #5 (tartrazine) that may cause allergic-type reactions (including bronchial asthma) in certain people. It is frequently seen in patients who also have aspirin hypersensitivity.
  • Patients should be directed to take CLOVIQUE™ on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed. For the first month of treatment, the patient should have his temperature taken nightly, and he should be asked to report any symptom such as fever or skin eruption.
  • In general, mineral supplements should not be given since they may block the absorption of CLOVIQUE™.
  • CLOVIQUE™ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • The following adverse reactions have been reported in a clinical study using trientine hydrochloride: iron deficiency, systemic lupus erythematosus. In addition, dystonia, muscular spasm, myasthenia gravis have been reported in marketed use.
  • CLOVIQUE™ carton should be kept refrigerated at 2ºC - 8ºC (36ºF - 46ºF).
  • For patient convenience, individual blister pack (or tray) may be stored for a maximum single period of 30 days at or below room temperature (25ºC (77ºF)) with protection from sources of heat and humidity. Capsules stored at room temperature should be discarded after 30 days.

Please see full Prescribing Information for CLOVIQUE™ Capsules.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. You may also contact Kadmon Pharmaceuticals, LLC at 1-877-377-7862 to report negative side effects.

1 Miloh T, Graper M, Schilsky M. Evaluating diagnosis and management gaps in Wilson disease: results from a qualitative patient survey. Advances in Rare Diseases. 2018; 4(1): 1-8.

2 Gaffney D, Fell GS, O'Reilly DS. ACP Best Practice No 163. Wilson's disease: acute and presymptomatic laboratory diagnosis and monitoring. J Clin Pathol. 2000;53(11):807-812.

3 European Association for Study of Liver. EASL Clinical Practice Guidelines: Wilson's Disease. J Hepatol. 2012;56(3):671-685.

4 CLOVIQUE™ Package Insert. Kadmon Pharmaceuticals, LLC 2018

Forward Looking Statements

This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) our reliance on the success of our product candidates; (iv) the timing or likelihood of regulatory filings and approvals; (v) our ability to expand our sales and marketing capabilities; (vi) the commercialization of our product candidates, if approved; (vii) the pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in the United States, Europe and other jurisdictions; (xiii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xv) our ability to maintain and establish collaborations or obtain additional grant funding; (xvi) the rate and degree of market acceptance of our product candidates; (xvii) developments relating to our competitors and our industry, including competing therapies; (xviii) our ability to effectively manage our anticipated growth; (xix) our ability to attract and retain qualified employees and key personnel; (xx) our ability to achieve cost savings and other benefits from our efforts to streamline our operations and to not harm our business with such efforts; (xxi) the use of proceeds from our recent public offerings; (xxii) the potential benefits of any of our product candidates being granted orphan drug designation; (xxiii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; and/or (xxiv) other risks and uncertainties. More detailed information about Kadmon and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the U.S. Securities and Exchange Commission (the "SEC"), including the Company's Quarterly Report on Form 10-Q filed with the SEC on August 5, 2019. Investors and security holders are urged to read these documents free of charge on the SEC's website at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contact Information
Ellen Cavaleri, Investor Relations
646.490.2989
ellen.cavaleri@kadmon.com

SOURCE: Kadmon Holdings, Inc.



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