Wednesday, biotechnology unit of drug maker Roche Holding AG (RHHBY.PK), Genentech, Inc., announced a phased voluntary withdrawal of the plaque psoriasis drug Raptiva from the U.S. market. The company said that the decision was based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy PML - a fatal viral disease that that attacks the white matter of the brain and leads to death or severe disability.
Of three cases of diagnosed PML in patients receiving Raptiva, one patient developed progressive neurologic symptoms and died of unknown cause. On February 19, EU recommended suspension of Raptiva sales after finding the linkage of drug to four cases of a deadly brain infection.
Raptiva would no longer be available after June 8, 2009. Genentech said the transition period would enable patients currently using Raptiva time to work out alternatives with their doctors and discontinue Raptiva in an appropriate manner. Genentech estimates that about 2,000 patients in the U.S. may currently be receiving Raptiva for chronic plaque psoriasis.
Hal Barron, Genentech's senior V.P, development and chief medical officer, said, 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.
Roche reported that U.S. sales of Raptiva for 2008 were about $108 million. The phased withdrawal of Raptiva does not affect the Group's net income and EPS for 2009, but excess Raptiva inventories would be resulting in a one-time cost-of-sales charge of about $125 million, to be reflected in its results for the first half of 2009.
RHHBY.PK closed Wednesday's trading at $32.79, down $0.51 or 1.53% on the OTC.
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