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FDA Grants Orphan Drug Designation to Kadmon's KD025 for the Treatment of cGVHD
[October 06, 2017]

FDA Grants Orphan Drug Designation to Kadmon's KD025 for the Treatment of cGVHD


Kadmon Holdings, Inc. (NYSE: KDMN) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to KD025, the Company's Rho-associated coiled-coil kinase (ROCK) inhibitor, for the treatment of chronic graft-versus-host disease (cGVHD), a serious complication following allogeneic bone marrow or stem cell transplantation.

KD025 is being studied in an ongoing Phase 2 clinical trial in adults with steroid-dependent or steroid-refractory cGVHD and active disease. The dose-finding study includes 48 patients divided into three cohorts at different dose levels (KD025 200 mg QD, 200 mg BID and 400 mg QD), enrolled sequentially following a safety assessment of each cohort. As previously reported, in a preliminary analysis of data from the lowest-dose cohort (n=17), KD025 200 mg QD demonstrated clinically meaningful responses, with no drug-related serious adverse events recorded.

"cGVHD is a debilitating condition with few available therapies, and many patients lack treatment options," said Harlan W. Waksal, M.D., President and CEO at Kadmon. "We are pleased with the continued progress of KD025 in the ongoing clinical trial, and we anticipate presenting additional data from the study toward the end of this year."

The FDA grants orphan designation to promote the development of promising products for rare conditions affecting fewer than 200,000 U.S. patients annually. It qualifies a company for certain financial benefits, including seven years of market exclusivity following marketing approval, tax credits for clinical research costs, eligibility for Orphan Product grants and the waiver of certain administrative fees.

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 product pipeline focused on autoimmune and fibrotic diseases.

Forward-Looking Statements

This press release contains forard-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; and/or (xxii) the potential benefits of any of our product candidates being granted orphan drug designation. 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 ("SEC (News - Alert)"), including the Company's Quarterly Report on Form 10-Q filed pursuant to Section 13 of the Securities Exchange Act of 1934, as amended, with the SEC on August 3, 2017. Investors and security holders are urged to read these documents free of charge on the SEC's web site 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.



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