The agreement will expand the availability of the first and only U.S. FDA-approved prescription product for the treatment of raised seborrheic keratoses (SKs)
WAYNE, Pa., April 06, 2018 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, today announced that it has licensed the Canadian rights to commercialize A-101 40% topical solution for the treatment of raised seborrheic keratoses (A-101 40%) to Cipher Pharmaceuticals (TSX:CPH). A-101 40% was approved by the FDA in December 2017 and is marketed by Aclaris in the U.S. under the tradename Eskata™.
Neal Walker, CEO of Aclaris commented, “This agreement marks an important milestone for Aclaris as our first entry into the international dermatology market. Cipher has a strong presence within the Canadian dermatology market and we are excited to be working with them to make A-101 40% available in Canada.”
“We were very attracted to the profile of A-101 40%, which has the potential to address a growing and unmet need for a non-invasive prescription treatment option targeting the estimated 20% of Canadians who have raised SKs,” said Robert Tessarolo, President and CEO of Cipher. “This transaction – which represents our fourth in 2018 – brings a new and differentiated dermatology product into our Canadian portfolio and presents an attractive long-term growth opportunity. The addition of A-101 40% will further leverage our sales force and the strong relationships we have with Canadian dermatologists. Supported by a robust clinical data package, we are targeting a New Drug Submission to Health Canada later this year.”
Terms of the Transaction
Under the terms of the license agreement, Aclaris will receive an upfront payment of US $1.0 million and upon achievement of certain milestone events, may receive additional regulatory and commercial milestone payments, as well as royalties from product sales of A-101 40% in Canada. Cipher will be responsible for all regulatory and commercial activities and expenses for A-101 40% in Canada.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in dermatology, both aesthetic and medical, and immunology. Aclaris’ focus on market segments with no FDA-approved medications or where treatment gaps exist has resulted in the first FDA-approved treatment for raised seborrheic keratoses and several clinical programs to develop medications for the potential treatment of common warts, alopecia areata, and vitiligo. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.
About A-101 40% for the treatment of raised SKs
A-101 40%, marketed under the trademark, ESKATA, by Aclaris in the U.S. is the first and only U.S. FDA-approved medication for the treatment of raised seborrheic keratoses (SKs). Aclaris has submitted a Marketing Authorization Application (MAA) for this product in select countries in the European Union.
About Cipher Pharmaceuticals Inc.
Cipher (TSX:CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. Cipher is focused on a three-pronged growth strategy – including acquisitions, in-licensing, and selective investments in drug development – to assemble a broad portfolio of prescription products that serve unmet medical needs. For more information, visit www.cipherpharma.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", "may", "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding Aclaris’ preclinical and clinical development of its drug candidates and the commercialization of ESKATA. 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, 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, 2017 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "Financial Information" section of the Investors page of Aclaris' website at http://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.
Michael Tung, M.D.
Senior Vice President
Corporate Strategy/Investor Relations