Genentech will voluntary withdraw the psoriasis drug Raptiva (efalizumab) from the U.S. market due to the association with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal CNS disease. Raptiva is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older. There have been three cases of diagnosed PML in patients taking Raptiva and one patient who developed progressive neurologic symptoms but died of unknown cause. It is not known whether other, unreported cases have occurred.

Raptiva will no longer be available in the U.S. after June 8, 2009. This transition period is intended to allow patients currently taking Raptiva to work with their doctors to appropriately discontinue use of Raptiva and assess treatment alternatives. The company estimates that approximately 2,000 patients in the U.S. may currently be taking Raptiva for chronic plaque psoriasis. Since the drug was approved in 2003, approximately 46,000 patients worldwide have been treated with Raptiva. Genentech is working with Merck Serono, its licensee outside the U.S. and Japan to inform regulatory authorities of the decision to withdraw Raptiva from the U.S. market.

“Our decision to remove Raptiva from the market reflects Genentech’s commitment to patient safety,” said Hal Barron, M.D., Genentech’s senior vice president, development and chief medical officer. “Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed.”

Raptiva’s prescribing information was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML. The Raptiva prescribing information was further updated in March 2009 to include more information on the risk of PML and a new Medication Guide for patients.

U.S. sales of Raptiva in 2008 were approximately $108 million. The company will take a one-time cost-of-sales charge of approximately $125 million in its results for 1H09 to account for the withdrawal. The impact on net income and EPS will not be significant, and Roche’s targets for 2009 are not affected. Roche acquired Genentech last month.