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BARRIER THERAPEUTICS, INC. We are a biopharmaceutical company focused on the discovery, development and commercialization of a portfolio of innovative pharmaceutical products to address major medical needs in the field of dermatology. We currently have multiple product candidates in clinical development, with four of these candidates in or entering Phase III clinical trials. We believe that there exists significant commercial opportunity for a company focused specifically on the treatment of dermatological diseases, given the relatively fragmented nature of the dermatology market and the clinical limitations of currently approved treatments. Finally, we believe that we will be able to effectively commercialize our products, if approved, using a focused, specialty sales force. Our Product Development Pipeline Our product pipeline includes eight product candidates in various stages of clinical development for the treatment of a range of dermatological conditions. We also have a number of products in preclinical development, one of which we expect will enter clinical development in 2005. In addition, we have rights to two other products that are marketed by third parties in some countries outside the United States and Europe, which we plan to reformulate prior to initiating clinical trials. Our four most advanced product candidates are Sebazole, Zimycan, Hyphanox and Liarozole. Sebazole. Sebazole is a topical formulation of 2.0% ketoconazole, an antifungal agent, in a waterless gel that we are developing as a once daily treatment for seborrheic dermatitis. Seborrheic dermatitis is an inflammation of the skin that is characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, behind the ears and in the middle of the chest, which affects approximately 8.5 to 14.3 million people in the United States. The most commonly used prescription drugs for the treatment of seborrheic dermatitis typically must be used at least twice daily for four to six weeks to be effective in treating this condition. If approved, we believe that Sebazole would have favorable attributes, including a dosing regimen of once daily treatment for two weeks, a fast onset of action and a lower likelihood of recurrence of symptoms in comparison with steroid treatment. In November 2003, we completed two Phase III clinical trials for the treatment of seborrheic dermatitis in which Sebazole achieved the primary efficacy endpoint with statistical significance. Zimycan. Zimycan is a topical ointment of 0.25% miconazole, an antifungal agent, in a zinc oxide and petrolatum base. We are developing Zimycan for the treatment of infants with Candida-associated diaper dermatitis, which is an inflammatory disease in which an infant’s diaper rash is complicated with an infection by a fungus called Candida. Diaper dermatitis is one of the most common skin conditions in infants and is observed in approximately one million pediatric outpatient visits each year. Based on multiple published reports, we believe that more than 40% of all diaper dermatitis involves Candida. In the United States, there currently is no prescription drug approved to treat Candida-associated diaper dermatitis. If approved, we believe that Zimycan would have favorable attributes, including a formulation without a steroid that is specifically designed for Candida-associated diaper dermatitis. In the first quarter of 2003, we commenced a Phase III pivotal clinical trial for the use of Zimycan in the treatment of infants with proven Candida-associated diaper dermatitis to support a new drug application in the United States. In June 2003, we filed a marketing authorization application for Zimycan in the treatment of Candida-associated diaper dermatitis under the European Union’s mutual recognition procedure. Hyphanox. Hyphanox is an oral formulation of itraconazole, an antifungal agent, that we are developing for the treatment of various fungal infections, including vaginal candidiasis, commonly known as vaginal yeast infection, tinea pedis, commonly known as athlete’s foot, and onychomycosis, commonly known as nail fungus. Vaginal candidiasis, tinea pedis and onychomycosis are commonly occurring fungal infections and we believe that treatments for these diseases represent a significant market opportunity. Itraconazole is effective in treating these fungal infections. We recently commenced a Phase III pivotal clinical trial for the use of a single day, single dose treatment of two 200 mg tablets of Hyphanox in the treatment of vaginal candidiasis. This trial will compare Hyphanox to Diflucan, the most widely prescribed oral treatment for this disease. In the second quarter of 2004, we plan to initiate a Phase III pivotal clinical trial for tinea pedis and, in early 2005, we plan to initiate Phase III pivotal clinical trials for onychomycosis. Janssen Pharmaceutica Products, L.P. and a number of other Johnson & Johnson companies currently market different formulations of itraconazole, under Sporanox and other brand names, in various countries. In addition, Janssen has an exclusive option to acquire the right to commercialize Hyphanox on a region-by-region basis. It is possible that this option will become exercisable during 2004. Liarozole. Liarozole is our first product candidate based on a class of molecules known as retinoic acid metabolism blocking agents, or RAMBAs. We are developing Liarozole as an oral treatment for congenital ichthyosis. Congenital ichthyosis is a rare genetic disease, affecting one in 6,000 people in the United States, characterized by severe dryness and scaling of the skin with the scaling often occurring over large areas of the body. There is no oral prescription drug currently approved in the United States that is indicated for the treatment of congenital ichthyosis. Liarozole has been granted orphan drug status in Europe for the treatment of congenital ichthyosis and we recently filed an application for orphan drug status for Liarozole for this indication in the United States. We expect to commence a Phase III clinical trial for Liarozole by the end of 2004. Our four product candidates in earlier stages of clinical development are Rambazole, Azoline, Hivenyl and Atopik. Our product candidate in preclinical development which we expect will enter clinical development in 2005 is Ecalcidene. Rambazole. Rambazole is our second product candidate based on the RAMBA class of molecules. We are developing an oral formulation of Rambazole for the treatment of psoriasis and severe acne. Preclinical studies suggest that Rambazole is more selective and more active than first generation RAMBA-based product candidates, such as Liarozole. We intend to initiate two pilot clinical studies using oral Rambazole in Europe in the first half of 2004 to determine safety and preliminary indications of effectiveness in the treatment of both psoriasis and severe acne. Azoline. Azoline is an antifungal agent that we are developing as a short course oral treatment for skin and mucosal fungal infections. We have completed a Phase I clinical trial for Azoline, which indicated that at the doses tested, Azoline has a half-life in the body which is nearly three times longer than that of itraconazole. In 2004, we intend to pursue additional pilot clinical studies in Europe for the use of Azoline in treating various types of dermatological fungal infections. Hivenyl. Hivenyl is an antihistamine that we are developing as an oral treatment for allergic reactions of the skin, such as hives, which will not cause sedation typically associated with antihistamines. The results of two Phase I clinical trials suggest that Hivenyl inhibits allergic reactions, has a fast onset of action and does not cause sedation. Atopik. Atopik is a PDE4 inhibitor that we are developing as a topical treatment for eczema, which is an inflammatory skin condition. In a pilot clinical study, Atopik reduced inflammatory response to stimuli that cause dermatitis. Ecalcidene. Ecalcidene is an orally available vitamin D3 derivative that we are developing for the treatment of psoriasis. Based on preclinical studies, we believe that Ecalcidene may offer benefits over natural vitamin D3 in the treatment of psoriasis. It has demonstrated the potential to become the first vitamin D3 derivative that can be taken orally on a routine basis. Our Business Strategy Our strategy is to develop a portfolio of innovative products that address major medical needs in the treatment of dermatological diseases and disorders in order to become a global leader in the discovery, development and commercialization of prescription pharmaceutical products in the field of dermatology. To achieve our goal, we intend to: • aggressively pursue the development and regulatory approval of our product candidates; • commercialize our products directly through our own sales organization in the United States and through collaborations with third parties outside the United States; • maintain a diverse portfolio of product candidates at various stages of preclinical and clinical development; and • expand our product portfolio through a combination of internal development efforts and selective in-licensing of additional compounds. Johnson & Johnson Relationship We were founded in 2001 by Geert Cauwenbergh, our Chief Executive Officer, who identified a portfolio of dermatological product candidates and intellectual property within the Johnson & Johnson family of companies that he believed could form the basis for an independent pharmaceutical company focused on dermatology. In May 2002, we acquired these assets through licenses from Janssen Pharmaceutica Products, L.P., Johnson & Johnson Consumer Companies, Inc. and Ortho-McNeil Pharmaceutical, Inc., each a Johnson & Johnson company, in exchange for an equity interest in us. Early-Stage Company We have a limited operating history, have not completed the development of any of our product candidates and have not yet received marketing authorization for any of our product candidates. We have not been profitable in any quarter since inception. For the nine months ended September 30, 2003, our net loss was $13.3 million and, as of that date, we had a deficit accumulated during the development stage of $51.9 million. Even if we succeed in developing and commercializing one or more of our product candidates, we may never achieve sufficient sales revenue to achieve or maintain profitability. We expect to incur operating losses for the foreseeable future. We were incorporated under the laws of the State of Delaware in September 2001 as “Barrier Health Technologies, Inc.” We changed our name to “Barrier Therapeutics, Inc.” in April 2002. Our principal executive offices are located at 600 College Road East, Suite 3200, Princeton, New Jersey 08540. Our telephone number is (609) 945-1200. Our website address is www.barriertherapeutics.com. The information on our website is not a part of this prospectus. We have included our website address in this document as an inactive textual reference only. | ||||||||||||||
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