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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We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the "Risk Factors" section of our Annual Information Form and in our Management's Discussion and Analysis of Operating Results and Financial Position for the year ended December 31, 2017, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language.
SOURCE Cipher Pharmaceuticals Inc.
For further information: Stefan Eftychiou, Bristol Investor Relations, (905) 326-1888 ext. 60, [email protected]