Serono S.A. and Genentech Inc have entered into an agreement under which Serono will receive an exclusive license to market the psoriasis treatment Raptiva (efalizumab, formerly Xanelim) internationally outside of the United States, Japan, and certain other Asian countries. Development and marketing rights in the United States remain with Genentech and its U.S. partner XOMA(US) LLC and Genentech retains exclusive marketing rights in Japan and certain other Asian countries. Under the agreement, Genentech, Serono and XOMA may collaborate on co-developing future indications for Raptiva and will share certain global development costs. Financial terms of the agreement were not disclosed.
A humanized monoclonal antibody, Raptiva is a targeted T-cell modulator designed to inhibit three key inflammatory processes in the cascade of events that are associated with psoriasis. These processes are: (1) binding of T-cells through interactions with adhesion molecules on the endothelial cell surface; (2) trafficking of T-cells into the skin; and (3) activation of T-cells, all of which may be linked to the abnormal growth of skin cells and the painful, elevated scaly patches of skin (lesions) typical among psoriasis sufferers. Raptiva is administered subcutaneously (under the skin) once per week.
Raptiva is being developed in the U.S. through a partnership between Genentech and XOMA, and is currently in Phase III clinical testing for the treatment of moderate-to-severe plaque psoriasis. Pending data from an additional efficacy study and discussions with the FDA, Genentech and XOMA anticipate filing a Biologics License Application (BLA) for Raptiva in psoriasis by the end of 2002. Serono plans to file Raptiva with European regulatory authorities during the first quarter of 2003.
Raptiva is also in Phase II clinical testing in rheumatoid arthritis as a potential therapy for moderate-to-severe disease, and Genentech, Serono and XOMA may collaborate on co-developing this additional indication for Raptiva.
Psoriasis is a chronic autoimmune disease that affects approximately 5.7 million patients in Europe and approximately 4.5 million people in the U.S. Psoriasis is characterized by the abnormal growth of new skin cells, resulting in thick, red, scaly, inflamed patches. Psoriasis is not a contagious disease.
Psoriasis may be one of several types: plaque psoriasis, pustular psoriasis, erythrodermic psoriasis, guttate psoriasis, or inverse psoriasis. Plaque psoriasis, the most common form of the disease, is characterized by inflamed patches of skin ("lesions") topped with silvery white scales. Psoriasis can be limited to a few spots or involve extensive areas of the body, appearing most commonly on the scalp, knees, elbows and trunk. Psoriasis is categorized as mild, moderate or severe, depending on the percentage of body surface area involved and the impact of the patient's quality of life.
Existing treatments for psoriasis are topical (applied to the skin), systemic (taken internally), or phototherapeutic (ultraviolet light applied to the skin). While some current treatments may help control the symptoms of psoriasis, their benefits are not long-lasting and may be associated with serious side-effects. There currently is no known cure.