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FDA Approves Graceway Pharmaceuticals, LLC's Zyclara(TM) (imiquimod) Cream, 3.75% for the Treatment of Actinic Keratoses


3/29/2010 7:03:48 AM

BRISTOL, Tenn., March 26 /PRNewswire/ -- Graceway® Pharmaceuticals announced today that the Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Zyclara™, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK). The new treatment can be used on large areas of skin, including the full face or balding scalp on a convenient, 6-week dosing cycle.

Zyclara shares the same active ingredient as Aldara® (imiquimod) Cream, 5% and while both topicals are FDA-approved for the treatment of AK, there are notable differences between the two. Zyclara is indicated for daily use on an accelerated 6-week dosing cycle comprised of two weeks of daily treatment with Zyclara, two weeks of non-treatment, followed by two weeks of daily treatment with Zyclara. Aldara is not approved for daily use and its approved dosing regimen is for a full 16 weeks. Additionally, Zyclara is indicated for use on larger areas of skin, the full face or balding scalp, while Aldara is restricted to a 25 cm2 area of skin.

If there are AKs visible on the surface of the skin, it is likely that there are more AKs just below the skin's surface. Zyclara revealed these AKs, in 86 percent of patients. In the study, Zyclara treated both types of AKs – those found at the start of the study and those unmasked during treatment. Additionally, over 40 percent of doctors reported Zyclara "significantly improved" the appearance of patients' skin.

"When Graceway acquired Aldara, we knew we had a good product for treating actinic keratoses, but we believed we could improve it," said Jefferson J. Gregory, chairman and CEO of Graceway Pharmaceuticals. "In Zyclara clinical trials, we successfully defined a shorter treatment regimen for a larger surface area with an excellent efficacy and safety profile."

In clinical trials, with patients averaging 11 AKs at baseline, Zyclara reduced the total number of AKs by 82 percent. Complete clearance of all AKs (including lesions revealed during treatment) was achieved in 36 percent of patients as compared to only 6 percent of those on placebo. Partial clearance (75 percent reduction or greater in AK totals) was achieved in 59 percent of those treated with Zyclara versus 23 percent for placebo. Additionally, over 85 percent of patients experienced an increase in AK counts after the start of Zyclara treatment. Clearance rates reflect treatment of visible lesions at baseline, as well as new lesions revealed during treatment.

"Because AKs are pre-cancerous and can develop on skin frequently exposed to the sun, such as the face or balding scalp, an effective treatment that can be used on large areas of skin is beneficial," said Darrell Rigel, M.D., clinical professor of dermatology, New York University Medical Center. "The approval of Zyclara may offer patients a convenient option for treating multiple AKs in a single short course of treatment."

Zyclara will be supplied in a new 28-sachet pack comprised of single-use packets, each of which contains 250 mg of cream. Because the dose is controlled, it may make the 6-week dosing regimen more intuitive for patients.

About the Zyclara Clinical Studies

The Phase III clinical program was designed to evaluate safety, efficacy and optimal dosing regimen of imiquimod for the treatment of AK and was comprised of double-blind, placebo-controlled studies. The studies enrolled 319 adults with five to 20 AK lesions in a large treatment area (full face or balding scalp). The patients were randomized to either placebo or Zyclara (1:1).

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.

The majority of subjects in the Zyclara group had increases in the number of lesions from baseline during treatment. Clearance rates reflect treatment of both visible or palpable and new lesions revealed during treatment.

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

About 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 may 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 Zyclara™

Zyclara is the brand name for imiquimod cream, 3.75%, which is an immune-response modifier. Zyclara Cream is a skin-use only (topical) prescription medicine used to treat actinic keratoses on the full face or balding scalp of adults with normal immune systems.

Zyclara is applied once daily for two weeks. There is no treatment for the next two weeks. Zyclara is then applied once a day for another two weeks.

For more information on Zyclara, visit http://www.ZyclaraCream.com.

About Aldara®

Aldara is the brand name for imiquimod cream, 5%, which is an immune-response modifier. Aldara Cream is a skin-use only (topical) prescription medicine used to treat certain types of actinic keratoses on the face and scalp of adults with normal immune systems.

When using Aldara Cream, the most common side effects involve skin reactions in the application area. These include redness, swelling, erosions, weeping, scabbing, itching and burning. Most skin reactions are considered mild to moderate.

When using Aldara Cream for actinic keratoses, exposure to sunlight (including sunlamps) should be avoided or minimized because of concern of heightened sunburn susceptibility. Patients should be warned to wear protective clothing (e.g., hat) when using Aldara Cream.

About Graceway® Pharmaceuticals, LLC

Graceway Pharmaceuticals, LLC ("Graceway"), headquartered in Bristol, TN, is a pharmaceutical company focused on acquiring, in-licensing, and developing branded prescription pharmaceutical products. Current prescription products marketed by Graceway include Zyclara™ (imiquimod) Cream, 3.75%, 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.


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