Raptiva Risks Outweighed Benefits

Washington, DCOn April 8, 2009 Genentech Inc., the manufacturer of Raptiva (efalizumab) announced it has voluntarily withdrawn its psoriasis drug from the US market. The decision is based on the association of Raptiva and PML or progressive multifocal leukoencephalopathy, a rare and usually fatal disease of the central nervous system. Sadly, the withdrawal was not soon enough for three patients who have died from PML after taking Raptiva for more than three years. Another patient treated with Raptiva developed progressive neurologic symptoms and died of unknown cause.

Cearly the risks of Raptiva outweighed the benefits...

Since Raptiva was approved by the FDA in 2003, approximately 46,000 patients worldwide have been treated with the drug. Genentech estimates that about 2,000 people in the US may be currently taking Raptiva for chronic plaque psoriasis.

A close watch has been kept on Raptiva: in October 2008 it received a black box warning on the risk of serious infections, including PML. The European Medicines Agency and Canada recommended suspension of Raptiva in February. Then in March 2009 the prescribing information was further updated to include additional information on the risk of PML and a new Medication Guide for patients.

Physicians have been advised not to prescribe Raptiva for new patients and the drug will be phased out completely by June 8, 2009. Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer said " Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety… 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."

About PML

PML is a rare, progressive, demyelinating disease of the central nervous system that leads to death or severe disability. PML is caused by activation of the John Cunningham, (JC) virus. The JC virus resides in latent form in up to 80 percent of healthy adults, typically only causing PML in immunocompromised patients. The factors leading to activation of the latent infection are not fully understood, though abnormalities in T-cells may be important for reactivation and PML. PML has been reported in the published literature in HIV-positive patients, as well as immunosuppressed cancer patients (including patients with hematologic malignancies), organ transplant recipients, and patients with autoimmune diseases. There are no known interventions that can reliably prevent or adequately treat PML.

About Psoriasis

Psoriasis occurs when new skin cells grow abnormally, resulting in thick, red, and scaly, inflamed patches. Plaque psoriasis, the most common form of the disease, affects approximately 2.3 million Americans and 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. Although it is highly visible, psoriasis is not a contagious disease. While there are a number of medications that may help control the symptoms of psoriasis, there currently is no known cure.

Genenetech, a wholly-owned member of the Roche Group, with headquarters in South San Francisco, California reported that US sales of Raptiva in 20008 were about $108 million.