Cipher Pharmaceuticals Acquires Exclusive Canadian Rights to U.S. FDA-Approved A-101 40% Topical Solution from Aclaris Therapeutics
Published: Apr 06, 2018
MISSISSAUGA, ON, April 6, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) ("Cipher" or "the Company") today announced it has acquired from Aclaris Therapeutics, Inc. (NASDAQ:ACRS) ("Aclaris") the exclusive Canadian rights to distribute and commercialize A-101 40% topical solution ("A-101 40%"). A-101 40% is an FDA-approved product indicated for the treatment of raised seborrheic keratoses (SKs), which are commonly occurring non-cancerous skin growths that affect more than 9 million Canadian adults and can be an aesthetic skin concern. A-101 40% was approved by the FDA in December 2017 and is marketed by Aclaris in the U.S. under the tradename Eskata™.
A-101 40% is a proprietary, high-concentration hydrogen peroxide-based topical solution designed for in-office application by a healthcare provider. It is a targeted treatment applied directly to the raised SK using a pen-like applicator. The most commonly used approaches for SKs are surgical procedures such as cryosurgery, which can cause discomfort, cosmetic imperfections, and require wound management.
"Upon approval, we look forward to offering A-101 40% to dermatologists and their patients as a treatment that can clear raised SKs without cutting, burning or freezing the skin," said Robert Tessarolo, President and CEO of Cipher. "This transaction, our fourth in 2018, delivers on our commitment to bringing innovative therapies to market that address significant unmet needs. The addition of A-101 40% will further leverage our commercial organization and build upon the strong presence Cipher enjoys in the Canadian dermatology market and presents an attractive long-term growth opportunity. We are targeting a New Drug Submission to Health Canada later this year."
Neal Walker, CEO of Aclaris Therapeutics 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 expand the availability of A-101 40% in Canada."
Under the terms of the licensing agreement, Aclaris will receive an upfront payment of US$1.0 million and, upon achievement of certain milestone events, additional regulatory and commercial milestone payments, as well as royalties from product sales in Canada.
About Seborrheic Keratoses
Seborrheic keratoses (SKs) are non-cancerous skin growths that affect an estimated 20% of the population and are most commonly seen in middle-aged and older adults. SKs vary in color from flesh-colored to pink, yellow, gray, tan, brown, or black; can range in size from a millimeter to a few centimeters wide; and typically have a slightly elevated, waxy or scaly appearance. The number and size of SKs tends to increase with advancing age. SKs frequently appear in highly visible locations, such as the face or neck, but can also appear anywhere on the body, except the palms, soles and mucous membranes.
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 FDA-approved medication for the treatment of raised seborrheic keratoses (SKs). Aclaris has submitted a Marketing Authorization Application (MAA) for ESKATA in select countries in the European Union.
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 the 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 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.
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SOURCE Cipher Pharmaceuticals Inc.
Company Codes: OtherOTC:CPHRF, Toronto:CPH