Aclaris Therapeutics and Pediatrix Therapeutics Announce License Agreement for ATI-1777 in Greater China

WAYNE, Pa. and SHANGHAI, China, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, and Pediatrix Therapeutics, Inc. (Pediatrix), a pediatrics-focused therapeutic company, today announced that the companies have entered into a license agreement. Under the license agreement, Aclaris has granted Pediatrix the exclusive rights to develop, manufacture and commercialize ATI-1777, Aclaris’ investigational “soft” Janus kinase (JAK) 1/3 inhibitor, for any disease, including atopic dermatitis, in Greater China (Mainland China, Hong Kong, Macau and Taiwan). Aclaris will retain the rights to develop, manufacture and commercialize ATI-1777 in the rest of the world.

Under the terms of the agreement, Aclaris will receive an upfront payment of $5 million. In addition, Aclaris is eligible to receive milestone payments of up to $91 million if certain development, regulatory and commercial objectives are achieved. Aclaris is also eligible to receive a tiered royalty ranging from a low-to-high single digit percentage of net sales of ATI-1777 by Pediatrix in Greater China.

“We are very excited to partner ATI-1777 with Pediatrix in Greater China, expanding the potential global reach of our internally developed medicine in an area of continued unmet need,” said Jim Loerop, Chief Business Officer of Aclaris. “This serves as continued validation of the ability of our KINect^® drug discovery platform to generate valuable assets with potential to have high patient impact.”

Cheng Zhang, Chief Executive Officer of Pediatrix, added, “As a “soft” JAK 1/3 inhibitor, ATI-1777 could provide patients with atopic dermatitis with a new therapeutic option which minimizes the potential for systemic toxicities. Pediatrix is excited to continue the development of ATI-1777 to bring this innovative product to patients and families in China.”

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

About Pediatrix Therapeutics, Inc.

Pediatrix Therapeutics is a biotechnology company focusing on developing and commercializing high quality, pediatric-friendly and affordable therapeutics and healthcare products to children and families in China. The management team has an extensive track record of clinical development, regulatory affairs, CMC, business development and commercial operations. Leveraging the global development and licensing partnerships, Pediatrix Therapeutics has built a portfolio of more than 10 products in the therapeutics areas of interest, including dermatology, neurology, neonatology, allergy and immunology. For additional information, please visit www.pediatrixtherapeutics.com

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include Aclaris’ expectations regarding the potential reach and benefits of ATI-1777. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2021 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Therapeutics Contact:

Robert A. Doody Jr.
Vice President, Investor Relations
484-639-7235
rdoody@aclaristx.com