Barrier Therapeutics Submits Amendment to NDA for U.S. Regulatory Approval of Zimycan(TM)
PRINCETON, N.J., Nov. 29 /PRNewswire-FirstCall/ — Barrier Therapeutics, Inc. , a pharmaceutical company developing products in the field of dermatology, today announced the submission of an amendment to a pending New Drug Application (NDA) for Zimycan(TM). The submission includes results from a Phase III clinical study of diaper dermatitis complicated by candidiasis in infants, conducted by Barrier, in which Zimycan achieved statistical significance versus vehicle for all primary and secondary endpoints, as announced on August 10, 2004. The Company expects to receive a first action letter from the FDA relating to the approval of Zimycan during the first-half of 2005.
“The submission of this amendment to the Zimycan NDA is Barrier’s first major submission for product approval to the FDA and, as such, marks the achievement of an important milestone for Barrier,” commented Geert Cauwenbergh, Ph.D., Chairman and CEO of Barrier Therapeutics. “Our development team has done an outstanding job in completing this filing within the projected timing, and they will continue to work in the next months with the Agency toward obtaining approval for this treatment for diaper dermatitis complicated by candidiasis. The Company expects to receive a response from the FDA within the next six months.”
“In anticipation of obtaining approval for Zimycan we have been building a commercial organization to support its potential launch in the United States, which is anticipated early in the second half of 2005,” stated Al Altomari, Chief Commercial Officer of Barrier Therapeutics. “We are looking forward to our continued discussions with the FDA regarding Zimycan and remain committed to providing the resources necessary to bring this important treatment to market.”
As previously reported, the primary endpoint for the Phase III clinical study with Zimycan for diaper dermatitis complicated by candidiasis in infants was “overall cure” at day 14, one week after the end of treatment. “Overall cure” was defined as eradication of the fungus and complete clearing of all signs and symptoms of the disease. Results from the study showed that more than twice the percentage of patients treated with Zimycan reached the primary endpoint as compared with patients treated with the vehicle (p=0.005). The double-blind, vehicle-controlled study, which was conducted at 20 sites in the United States and Latin America, included 236 children under the age of 3 years who were diagnosed with diaper dermatitis that was complicated by the presence of the yeast, Candida. The children were treated for 7 days with either the vehicle, consisting of zinc oxide plus petrolatum, or with Zimycan, Barrier’s product consisting of 0.25% miconazole nitrate, an anti-fungal agent, in the zinc oxide petrolatum base.
At the end of treatment (day 7) the average reduction in the signs and symptoms score was 72% with Zimycan versus 25% with the vehicle ointment. Both Zimycan and the vehicle were well tolerated. There were no serious adverse events in either group nor were there adverse events related to treatment in either group. The non-serious adverse events were evenly distributed between the groups and were considered typical in this patient population.
Zimycan is a topical ointment consisting of 0.25% miconazole nitrate, an antifungal agent, in a zinc oxide and petrolatum base. Barrier is developing Zimycan for the treatment of infants with diaper dermatitis complicated by candidiasis, an inflammatory disease in which an infant’s diaper rash is complicated with an infection caused by the fungus called Candida. Diaper dermatitis, commonly known as diaper rash, is one of the most common skin conditions in infants and is observed in approximately one million pediatric outpatient visits each year in the United States. The Company believes that more than 40% of all diaper dermatitis treated by a physician involves Candida. In the United States, there currently is no prescription drug specifically approved to treat diaper dermatitis complicated by candidiasis. If and when approved by the FDA, the Company plans to initially market the product in the U.S. to pediatric dermatologists and pediatricians. The product has received marketing approval from the Belgian Health Authorities and is the subject of a Mutual Recognition Procedure (MRP) for approval in the major markets of Europe.
About Barrier Therapeutics, Inc.
Barrier Therapeutics, Inc. is a pharmaceutical company focused on the discovery, development and commercialization of pharmaceutical products in the field of dermatology. 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 diaper dermatitis complicated by candidiasis, seborrheic dermatitis, fungal infections, including vaginal candidiasis, 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. Web site: 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 timing and prospects for receiving regulatory approval, the timing of commercial launch, and the manner in which Barrier will commercialize the product, if approved. 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 September 30, 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. Barrier undertakes no obligation to update publicly any forward-looking statement.
Barrier Therapeutics, Inc.
Anne M. VanLent
Euro RSCG Life NRP
Barrier Therapeutics, Inc.
CONTACT: Anne M. VanLent of Barrier Therapeutics, Inc., +1-609-945-1202;or Mark Vincent of Euro RSCG Life NRP, +1-212-845-4239, for BarrierTherapeutics, Inc.
Web site: http://www.barriertherapeutics.com/