Late Tuesday afternoon, an advisory panel to the FDA unanimously recommended the approval of Raptiva -- co-developed by Genentech
Psoriasis, an immune-related chronic disease, affects approximately 4.5 million people in the United States, including approximately 1.5 million suffering from cases classified as moderate-to-severe. There is no known cure for the disease, but Raptiva seeks to control it. However, some worry that Raptiva must be administered constantly in order to be effective.
Because it interferes with the immune system, patients must stop taking Raptiva in order to give birth. Moreover, in cases where patients stopped taking the drug, the psoriasis flared. But the benefits of the drug appear to outweigh the risks.
Genentech anticipates approval by the October 27 action date and for the drug to hit the market by the end of 2003. Analysts believe that psoriasis treatments target a $1 billion market; however, Raptiva faces stiff competition.
Biogen's
Amgen
Genentech's drug is expected to generate $130 million next year, ultimately reaching between $400 and $710 million per year by 2007. Under the terms of its deal with Xoma, Genetech will receive 75% of Raptiva's revenues, while Swiss drug maker Sereno
This is big news for Xoma, as it will get its first big drug to market. The shares have doubled in the past two months in anticipation, and are up 4% to $9.77 in late-afternoon trading. Genentech is down 3% to $82.