In December 2004, CancerVax (Carlsbad, CA) signed a worldwide collaboration agreement with Serono (Geneva) for the development of Canvaxin, an investigational specific active immunotherapy for the treatment of melanoma. Canvaxin could be the first specific active immunotherapy to obtain marketing approval from the FDA. This type of therapy is also known as a therapeutic cancer vaccine.
Canvaxin is polyvalent. It is made up of three melanoma cell lines containing 38 antigens. This broad antigenic expression elicits a robust immune response in most melanoma patients. Canvaxin is made up of whole cells, not peptides or cell lysates, to elicit a strong, sustained immune response. Canvaxin is allogenic, so it can be given to all advanced-stage melanoma patients, unlike autologous therapeutic cancer vaccines that are only manufactured on a patient-specific basis.
Canvaxin is a surgical adjuvant therapy that is administered following surgery. Because tumors are immunosuppressive, patients have a better prognosis if the tumor is removed and they receive a therapeutic-specific active immunotherapy.
Barrier Therapeutics (Princeton, NJ) also has multiple product candidates that have been licensed from third parties in clinical development, with four of these candidates in or entering Phase III clinical trialSebazole, Zimycan, Hyphanox, and Liarozole.
Sebazole, designed to treat seborrheic dermatitis, comes in a waterless gel formulation. It is the first topical drug for seborrheic dermatitis with once-daily use for only two weeks. This common chronic disease affects 35 % of the U.S. population. Sufferers spent $220 million worldwide to treat the disease in 2003.
Barrier also seeks to develop Zimycan for Candida diaper dermatitis, one of the most common skin conditions in infants. While there are 8 million infants in the U.S. and a potential $120 million market for treating the condition, no prescription drug has been specifically approved for Candida diaper dermatitis.
Zimycan utilizes the antifungal effect of miconazole for the following benefits: low systemic exposure, no steroid side effects, and symptom relief of barrier ointment.
Barrier acquired the rights to market Solage, a topical solution used to treat solar lentigines, excessive pigmentation in Caucasians age 35 and up. Approximately 80% of these people have not seen a doctor, and the market exceeds $40 million in the U.S. and Canada alone.