Cipher Pharmaceuticals Announces A-101 40% Topical Solution Accepted for Review by Health Canada
MISSISSAUGA, ON, Dec. 18, 2018
MISSISSAUGA, ON, Dec. 18, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) today announced that its New Drug Submission ("NDS") for A-101 40% topical solution ("A-101 40%") for the treatment of raised seborrheic keratoses ("SKs") has been accepted for review by Health Canada. Cipher acquired the exclusive Canadian rights to distribute and commercialize A-101 40% from Aclaris Therapeutics, Inc. (NASDAQ:ACRS) ("Aclaris") in April 2018.
A-101 40% is a U.S. Food and Drug Administration ("FDA")-approved product indicated for the treatment of raised 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™.
"This is another significant milestone for Cipher as we continue to execute on our growth strategy and diversify our commercial portfolio," said Robert Tessarolo, President and CEO of Cipher. "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."
About 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 millimetre to a few centimetres 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 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.