PRINCETON, N.J., May 26 /PRNewswire-FirstCall/ -- Barrier Therapeutics, Inc. , a biopharmaceutical company developing pharmaceutical products for dermatology, today announced that it has begun enrolling patients in a confirmatory Phase III clinical trial for Sebazole(TM), for the treatment of seborrheic dermatitis. Seborrheic dermatitis is an inflammatory skin condition characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. Sebazole(TM) is a topical formulation consisting of 2.0% ketoconazole, an antifungal agent, formulated in a waterless gel for once-daily application.
The Company expects to enroll approximately 440 patients at 22 centers across the United States. The double-blinded, placebo-controlled study compares once-a-day Sebazole(TM) treatment to placebo (the waterless gel formulation alone) over two weeks of therapy. The primary efficacy endpoint is the proportion of patients who are effectively treated at day 28, which is 14 days following the end of the treatment period. For the purpose of this clinical trial, "effectively treated" means that a patient is "cleared" or "almost cleared" of seborrheic dermatitis, as determined by the physician's observation. This primary efficacy endpoint is identical to that used in the Company's prior Phase III trials for seborrheic dermatitis, noted below.
In January 2004, Barrier reported the results of two Phase III clinical trials for the treatment of seborrheic dermatitis in which Sebazole(TM) achieved statistical significance in the primary efficacy endpoint against the placebo gel (U.S. study: p<0.001 and Europe study: p<0.021). These Phase III trials, which enrolled more than 900 patients at approximately 50 centers in the U.S. and Europe, compared the safety and efficacy of the following treatment arms: Sebazole(TM); Barrier's gel containing 0.05% of the steroid desonide; Barrier's gel containing a combination of 2.0% ketoconazole and 0.05% desonide; and a placebo consisting of Barrier's gel with no active ingredient.
The current Phase III trial is being conducted in response to a request from the Food and Drug Administration (FDA) for a trial containing only two arms, Sebazole(TM) and placebo. It is expected to be completed by the end of 2004. The trial is subject to a Special Protocol Assessment, under which Barrier and the FDA have agreed on the design of the trial. The results of the study are expected to form the basis of a New Drug Application to the FDA.
Commenting on today's news, Geert Cauwenbergh, Ph.D., Chairman and Chief Executive Officer of Barrier said, "Seborrheic dermatitis can be a severe and chronic disease, making it difficult for some patients to control long-term. As a result, a treatment that would provide long lasting efficacy, and one which would require only one-fourth the number of applications as currently available treatments, could constitute a significant therapeutic advantage in terms of compliance."
Jonathan Weiss, M.D., Assistant Clinical Professor of Dermatology at Emory University in Atlanta, and a clinical investigator for Sebazole(TM), commented, "Seborrheic dermatitis is one of the most common skin conditions facing the dermatological community today. Although a great deal of work has already been done to better understand and address this disease, and while approved prescription therapies are available, most require twice-a-day application and lengthy treatment times. As a result, there is a real need for fast-acting and effective alternatives."
About Seborrheic Dermatitis
Seborrheic dermatitis is a skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The condition often recurs, thereby requiring re-treatment over time. Seborrheic dermatitis affects approximately 3% to 5% of the U.S. population. Barrier estimates that approximately 8.5 to 14.3 million people are affected. Current prescription therapies consist primarily of topical ketoconazole creams and topical steroids. These treatments typically require multiple applications per day over periods of up to four to six weeks to be effective.
About Barrier Therapeutics, Inc.
Barrier Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative pharmaceutical products to treat diseases of the skin. The Company has eight product candidates in various stages of clinical development. The four most advanced product candidates, which are in or entering Phase III clinical trials, are under development for the treatment of seborrheic dermatitis, Candida-associated diaper dermatitis, fungal infections, including vaginal candidiasis and onychomycosis, and congenital ichthyosis. Barrier has product candidates in earlier stages of clinical development for the treatment of acne, psoriasis, fungal infections, allergies and dermatitis. The Company is headquartered in Princeton, New Jersey and has a wholly-owned subsidiary in Geel, Belgium. Website: http://www.barriertherapeutics.com/
Safe Harbor Statement:
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the number of patients to be enrolled in the study, timing for completion of the study, the expected results of the study and the market prospects for Barrier's products. Forward-looking statements provide Barrier's current expectations or forecasts of future events. Barrier's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements please see the risk factors in Form 10-Q for the quarterly period ended March 31, 2004, which is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Barrier undertakes no obligation to update publicly any forward-looking statement.
Barrier Therapeutics, Inc.
The Company expects to enroll approximately 440 patients at 22 centers across the United States. The double-blinded, placebo-controlled study compares once-a-day Sebazole(TM) treatment to placebo (the waterless gel formulation alone) over two weeks of therapy. The primary efficacy endpoint is the proportion of patients who are effectively treated at day 28, which is 14 days following the end of the treatment period. For the purpose of this clinical trial, "effectively treated" means that a patient is "cleared" or "almost cleared" of seborrheic dermatitis, as determined by the physician's observation. This primary efficacy endpoint is identical to that used in the Company's prior Phase III trials for seborrheic dermatitis, noted below.
In January 2004, Barrier reported the results of two Phase III clinical trials for the treatment of seborrheic dermatitis in which Sebazole(TM) achieved statistical significance in the primary efficacy endpoint against the placebo gel (U.S. study: p<0.001 and Europe study: p<0.021). These Phase III trials, which enrolled more than 900 patients at approximately 50 centers in the U.S. and Europe, compared the safety and efficacy of the following treatment arms: Sebazole(TM); Barrier's gel containing 0.05% of the steroid desonide; Barrier's gel containing a combination of 2.0% ketoconazole and 0.05% desonide; and a placebo consisting of Barrier's gel with no active ingredient.
The current Phase III trial is being conducted in response to a request from the Food and Drug Administration (FDA) for a trial containing only two arms, Sebazole(TM) and placebo. It is expected to be completed by the end of 2004. The trial is subject to a Special Protocol Assessment, under which Barrier and the FDA have agreed on the design of the trial. The results of the study are expected to form the basis of a New Drug Application to the FDA.
Commenting on today's news, Geert Cauwenbergh, Ph.D., Chairman and Chief Executive Officer of Barrier said, "Seborrheic dermatitis can be a severe and chronic disease, making it difficult for some patients to control long-term. As a result, a treatment that would provide long lasting efficacy, and one which would require only one-fourth the number of applications as currently available treatments, could constitute a significant therapeutic advantage in terms of compliance."
Jonathan Weiss, M.D., Assistant Clinical Professor of Dermatology at Emory University in Atlanta, and a clinical investigator for Sebazole(TM), commented, "Seborrheic dermatitis is one of the most common skin conditions facing the dermatological community today. Although a great deal of work has already been done to better understand and address this disease, and while approved prescription therapies are available, most require twice-a-day application and lengthy treatment times. As a result, there is a real need for fast-acting and effective alternatives."
About Seborrheic Dermatitis
Seborrheic dermatitis is a skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The condition often recurs, thereby requiring re-treatment over time. Seborrheic dermatitis affects approximately 3% to 5% of the U.S. population. Barrier estimates that approximately 8.5 to 14.3 million people are affected. Current prescription therapies consist primarily of topical ketoconazole creams and topical steroids. These treatments typically require multiple applications per day over periods of up to four to six weeks to be effective.
About Barrier Therapeutics, Inc.
Barrier Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative pharmaceutical products to treat diseases of the skin. The Company has eight product candidates in various stages of clinical development. The four most advanced product candidates, which are in or entering Phase III clinical trials, are under development for the treatment of seborrheic dermatitis, Candida-associated diaper dermatitis, fungal infections, including vaginal candidiasis and onychomycosis, and congenital ichthyosis. Barrier has product candidates in earlier stages of clinical development for the treatment of acne, psoriasis, fungal infections, allergies and dermatitis. The Company is headquartered in Princeton, New Jersey and has a wholly-owned subsidiary in Geel, Belgium. Website: http://www.barriertherapeutics.com/
Safe Harbor Statement:
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the number of patients to be enrolled in the study, timing for completion of the study, the expected results of the study and the market prospects for Barrier's products. Forward-looking statements provide Barrier's current expectations or forecasts of future events. Barrier's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements please see the risk factors in Form 10-Q for the quarterly period ended March 31, 2004, which is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Barrier undertakes no obligation to update publicly any forward-looking statement.
Barrier Therapeutics, Inc.
© 2004 PR Newswire
