Kadmon Announces U.S. Availability of REZUROCK(TM) (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)

Rhea-AI Summary

Kadmon Holdings (NASDAQ: KDMN) announced the commercial availability of REZUROCK (belumosudil) 200 mg for patients in the U.S. on August 19, 2021. Approved by the FDA on July 16, 2021, REZUROCK treats chronic graft-versus-host disease (cGVHD) in patients 12 and older who have failed at least two systemic therapies. The drug is accessible through authorized specialty pharmacies, with commercial outreach efforts underway to ensure patient access. Approximately 14,000 patients in the U.S. are affected by cGVHD, highlighting the urgency for effective treatment options.

Positive

• REZUROCK is the first FDA-approved small molecule inhibitor of ROCK2 for cGVHD.
• REZUROCK demonstrates a unique safety profile allowing long-term therapy.
• Commercial availability through experienced specialty pharmacies ensures efficient patient access.

Negative

• None.

NEW YORK, NY / ACCESSWIRE / August 19, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced that REZUROCK™ (belumosudil) 200 mg once daily (QD) tablets is now commercially available for shipment to prescribed patients in the United States. REZUROCK was approved on July 16, 2021 by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy.

REZUROCK is available through a network of authorized specialty pharmacies and distributors. Amber Specialty Pharmacy, Biologics by McKesson and Onco360 Oncology Pharmacy, the approved specialty pharmacies of REZUROCK, have begun shipping to patients today.

"The availability of REZUROCK is a turning point for patients living with cGVHD as they seek new safe and effective treatment options for this debilitating disease," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "It is an honor to bring REZUROCK to the market as it has demonstrated efficacy, a unique safety profile and tolerability benefits which allow patients to stay on therapy long term and achieve meaningful improvement in their everyday quality of life."

REZUROCK is the first and only FDA-approved small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes. The FDA approval of REZUROCK was based on clinical results from ROCKstar (KD025-213), a randomized, open-label, multicenter pivotal trial of REZUROCK in patients with cGVHD who had received two to five prior lines of systemic therapy.

"We are committed to delivering REZUROCK into the hands of patients living with cGVHD through our extensive commercial outreach efforts," said Haya Taitel RPh, M.S., Chief Commercial Officer of Kadmon. "Our goal is to facilitate expeditious access to eligible patients. To that end, we have engaged with specialty pharmacies who have extensive experience providing the best care to cGVHD patients. We have also made REZUROCK available to academic institutions where patients are receiving treatment through a network of specialty distributors."

Kadmon offers programs to support patients and their caregivers throughout their treatment journey through Kadmon ASSIST^TM. Kadmon ASSIST offers a comprehensive suite of patient care and support services, including reimbursement assistance and savings programs for eligible patients. For more information, please visit www.kadmonASSIST.com or call 1-844-KADMON1 (1-844-523-6661), Monday-Friday, 8:00 a.m.to 8:00 p.m. ET.

For additional product information, please visit www.REZUROCKhcp.com.

About cGVHD
cGVHD is a complication that can occur following allogeneic stem cell transplantation, resulting in significant morbidity and mortality. In cGVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and gastrointestinal tract. Approximately 14,000 patients in the United States are living with cGVHD.

About REZUROCK™ (belumosudil)
REZUROCK™ (belumosudil) is the first and only approved therapy targeting Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and pro-fibrotic processes. REZUROCK is approved in the United States for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy. For more information, visit www.REZUROCK.com.

Kadmon is also developing belumosudil for the treatment of systemic sclerosis. The FDA has granted Orphan Drug Designation to belumosudil for the treatment of systemic sclerosis.

INDICATIONS AND USAGE
REZUROCK is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy.

SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception.

Adverse Reactions

The most common (≥20%) adverse reactions, including laboratory abnormalities, in patients receiving REZUROCK were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension.

To report suspected adverse reactions, contact Kadmon at 1-877-377-7862 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

Use in Specific Populations
Lactation: Advise not to breastfeed.

Please visit www.REZUROCK.com to see the full Prescribing Information for REZUROCK.

About Kadmon
Kadmon is a biopharmaceutical company that discovers, develops and delivers transformative therapies for unmet medical needs. REZUROCK™ (belumosudil), an oral, once-daily, tablet, is approved in the United States for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy. Kadmon's clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies. For more information, please visit the Company's website at www.kadmon.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations regarding REZUROCK™ (belumosudil) as a new available therapy, the timing of commercial availability of REZUROCK in the U.S., the commercial launch of REZUROCK in the U. S., the degree the NCCN Guidelines® influence the best course of treatment and supportive care for people living with cGVHD, and the potential benefit of our clinical and preclinical development programs for immune and fibrotic diseases as well as immuno-oncology therapies. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," "contemplate" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statement contained in this press release, including, without limitation, (i) our ability to commercialize REZUROCK and execute on our marketing plans for any other drugs or indications that may be approved in the future, (ii) risks that REZUROCK revenue, expenses and costs may not be as expected, (iii) risks relating to REZUROCK's market acceptance, competition, reimbursement and regulatory actions, (iv) risks and uncertainties related to the severity and duration of the impact of COVID-19 on our business and operations, including, without limitation, commercial and clinical drug supply chain continuity and the commercial launch of REZUROCK, (v) our ability to obtain and maintain reimbursement for REZUROCK and any approved product and the extent to which patient assistance programs and copay programs are utilized, (vi) our ability to successfully demonstrate the efficacy and safety of our product candidates including in later-stage studies, (vii) availability and timing of data from our preclinical and clinical trials, which may not support further development of our product candidates, (viii) our ability to manage our reliance on sole-source third parties such as our third party drug substance and drug product contract manufacturers, (ix) actions of regulatory agencies, (x) the inherent uncertainty in estimates of patient populations and incidence and prevalence estimates, (xi) competition from other products, (xii) our ability to comply with healthcare regulations and laws, (xiii) our ability to obtain, maintain and enforce our intellectual property rights, (xiv) our ability to maintain and establish strategic agreements and collaborations and the potential benefits of those arrangements and (xv) other risks, including active or potential litigation risks, any or all of which of the foregoing may affect the initiation, timing and progress of clinical studies and the timing of and our ability to obtain additional regulatory approvals, and make our investigational drugs and REZUROCK available to patients, and to derive revenue from product sales. More detailed information about us and the risk factors that may affect the realization of our forward-looking statements are set forth in our Securities and Exchange Commission (SEC) filings, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and subsequent filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC's website at www.sec.gov. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, except as may be required by law. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Contact Information
833.900.5366
Investors@kadmon.com

SOURCE: Kadmon Holdings, Inc.

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FAQ

What is REZUROCK and its significance for KDMN?

REZUROCK is a newly FDA-approved treatment for chronic graft-versus-host disease, making it significant for KDMN as it expands their product offering and addresses unmet medical needs.

When was REZUROCK approved by the FDA?

REZUROCK was approved by the FDA on July 16, 2021.

How is REZUROCK administered to patients?

REZUROCK is administered as a 200 mg once daily tablet.

What is the target patient population for REZUROCK?

REZUROCK is indicated for adult and pediatric patients aged 12 and older with cGVHD after failure of at least two prior lines of systemic therapy.

How many patients in the U.S. are living with cGVHD?

Approximately 14,000 patients in the U.S. are living with chronic graft-versus-host disease.