Psoriasis Treatment Clears Key Hurdle
Genentech Inc. and Xoma Ltd. said Tuesday that their experimental drug for the skin disorder psoriasis cleared a major hurdle, increasing the likelihood that it will be approved for sale.
Shares of Berkeley-based Xoma jumped 8% on the news, while stock in South San Francisco-based Genentech rose almost 3%.
The market for psoriasis drugs is estimated at more than $1 billion in the United States and as much as $5 billion globally. The disease, characterized by scaly bumps and raised patches on the skin, afflicts more than 100 million people around the world. Most psoriasis sufferers use ointments or creams.
The two biotechnology companies said batches of the drug, Raptiva, made by Genentech were just as effective in treating psoriasis as earlier batches of the medicine made from material manufactured by both firms.
The Food and Drug Administration asked the companies to conduct the additional study to prove that the drug could be duplicated at Genentech facilities without changing its chemical composition.
The FDA request, which delayed the drug’s potential introduction, came after the companies said in April that the Raptiva being manufactured by Genentech was qualitatively different from earlier batches.
The companies said they anticipate submitting an application by year-end seeking U.S. marketing approval for the drug.
Raptiva has shown impressive efficacy in clinical trials, reducing psoriasis by at least 75% in some 61% of patients taking the drug for about a year, said analyst Darren Mac of Fulcrum Global Partners.
The new study confirms an earlier trial showing that the proper weekly dose of Raptiva is 1 milligram per 1 kilogram of body weight, said Michael King, an analyst at Banc of America.
“Given this is consistent with the other results, this gives the FDA more comfort that Genentech has selected the right dose and I think makes the drug more approvable,” he said.
Biotechnology and drug companies are racing to be the first to market a psoriasis drug.
Last week, Biogen Inc. indicated that U.S. regulators probably would decide about marketing approval for its psoriasis drug, Amevive, in early 2003.
Other firms seeking to market psoriasis drugs include Johnson & Johnson and Amgen Inc., which hope to treat the skin disorder using their arthritis drugs Remicade and Enbrel, respectively. Arthritis drugs may be effective against psoriasis because both ailments are related to inflammation caused by an overactive immune system.
Shares of Xoma climbed 49 cents to $6.58 on Nasdaq. Genentech rose 92 cents to $31.75 on the New York Stock Exchange.
