Health Canada Approves Graceway Product for Precancerous Skin Condition

Patient-applied cream for actinic keratoses targets visible and sub-clinical lesions in short therapy treatment

BRISTOL, Tenn.--(BUSINESS WIRE)--Graceway Pharmaceuticals, LLC today announced that Health Canada has approved Zyclara^TM (imiquimod) Cream 3.75% for the treatment of multiple actinic keratosis (AK) of the face or balding scalp in adults with normal immune systems.

“Zyclara targets visible lesions but also clears sub-clinical lesions that exist beneath the surface of the skin.”

Actinic Keratosis is a common skin condition caused by chronic sun exposure. If left untreated, AK can lead to squamous cell carcinoma, a form of non-melanoma skin cancer.

Zyclara Cream works by boosting the body’s own immune system to recognize and respond to clear AK lesions safely and effectively.

As approved by Health Canada, Zylcara Cream is applied by the patient at home in a short course of therapy. It is used once daily, applied at bedtime to the skin of the face or balding scalp. Treatment duration is two weeks on, two weeks off, two weeks on, unless otherwise directed by a physician.

According to Erin Craven, General Manager of Graceway Pharmaceuticals Canada, “Zyclara targets visible lesions but also clears sub-clinical lesions that exist beneath the surface of the skin.”

The Phase III clinical studies enrolled 319 adults with five to 20 AK lesions in a large treatment area (full face or balding scalp). Patients applied up to 500 mg of cream daily for two, two-week cycles, separated by a no-treatment interval of two weeks. The primary endpoint was complete clearance, defined as the number of patients with zero AKs at the end of the study. The secondary endpoints were partial clearance rates and the percent change in AK number at the end of the study versus baseline. Efficacy was assessed eight weeks after the last dose.

Data from the Phase III trials revealed that Zyclara administered once-daily in two, two-week cycles was statistically superior to placebo. Patients treated with Zyclara had 36 percent complete clearance of AK versus six percent for placebo. Additionally, Zyclara reduced the total number of AKs by 82 percent.

The majority of subjects in the Zyclara group had increases in the number of lesions from baseline during treatment, consistent with the unmasking of subclinical AK lesions. Clearance rates reflect treatment of both visible or palpable and new lesions.

Local skin reactions, such as redness, are consistent with treatment response. The most commonly reported severe local skin reactions with Zyclara during the two-week treatment cycle regimen were redness (25 percent), scabbing/crusting (14 percent), skin peeling (11 percent), and flaking, scaling or dryness (8 percent).

Zyclara Cream is marketed in Canada by Graceway Pharmaceuticals and is available by prescription. Currently, imiquimod cream (3.75%) has not been approved by the United States Food and Drug Administration (FDA).

Actinic Keratosis

AK is a sign of sun damage resulting from long-term exposure to harmful UV rays. The sun’s rays cause changes in the size, shape, and organization of the top layer of skin cells, also known as the epidermis, and just below it. These cellular mutations can then form AKs.

AK is considered a pre-cancer and may often be confused with age spots, eczema or psoriasis. AKs are small, red, sometimes scaly or rough patches that can be found on skin most often exposed to the sun like the face, bald scalp, hands, shoulders and arms. AKs can vary in shape and color, ranging from red to light or dark tan, pink, or a combination of these. These lesions may range from the size of a pinhead to larger than a quarter and may feel dry and rough like sandpaper. In the beginning, AKs can be so small that they are often identified by their rough texture rather than by sight.

Some AKs will develop into a serious form of skin cancer called squamous cell carcinoma, or SCC. If left unchecked, this cancer can spread to other areas of the body and organs. Because it is difficult to predict whether an AK will develop into cancer, it is important to discuss any changes in your skin with a doctor.

About Graceway Pharmaceuticals

Graceway Pharmaceuticals, LLC ("Graceway"), headquartered in Bristol, TN, is a pharmaceutical company focused on acquiring, in-licensing, and developing branded prescription pharmaceutical products. Graceway initially acquired the imiquimod franchise as part of its acquisition of 3M’s (NYSE: MMM) branded pharmaceutical business in the United States, Puerto Rico, Canada and Latin America. Graceway has also recently completed acquisitions of other molecules or compounds from, among other companies, Pfizer, Inc. (NYSE: PFE) and Gilead Sciences, Inc. (NASDAQ: GILD). Current prescription products marketed by Graceway include Aldara^® (imiquimod) Cream, 5%, Maxair^®Autohaler^® (pirbuterol acetate inhalation aerosol), Atopiclair^® Nonsteroidal Cream, and Estrasorb^® (estradiol topical emulsion). Zyclara^™ , Aldara^®, Maxair^®, Autohaler^®, Atopiclair^®, and Estrasorb^® are trademarks owned by or licensed to Graceway. For more information on Graceway's products, including important safety information, please visit www.gracewaypharma.com.