Biogen Inc. (NASDAQ:BIIB)
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Biogen Idec Inc. (BIIB) disclosed three more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 58 as of July 2.
The Cambridge, Mass., biotech company reported an additional death among patients that have developed progressive multifocal leukoencephalopathy, or PML, bringing the total to 12.
Tysabri is considered a highly effective therapy for MS, and its growth is important to the future of both Elan and Biogen. But its sales have been slower than originally hoped due to concerns about the risk of PML that led to its temporary withdrawal beginning in 2005. The infection re-emerged in mid-2008, and Biogen provides regular updates about the number cases.
The overall global PML rate is about 0.80 per 1,000 patients, the company said, which falls within the 1-in-1,000 rate previously seen in clinical trials and implied on the drug's label.
Shares of Biogen closed up 46 cents to $53.43, while Elan's American depositary shares dropped 4% to $5.08.
Of the total cases, 22 were in the U.S., 32 were in the European Union and four were in other areas.
The number of cases is important because if the infection rate climbs too high, sales of the drug may drop. A patient's risk of getting PML increases with the number of monthly infusions that he or she receives.
The most recent update translates to a rate of 1.27 cases per 1,000 for patients on the drug for a year or longer, but rises to 1.71 per 1,000 for those on the drug for two years or longer.
Looked at another way, the rate is about 1.42 cases per 1,000 patients on the drug for between two and three years. The incidence is about 0.37 case per 1,000 patients in those using it for one to two years, and it is almost nonexistent in patients using it for less than a year.
Elan sets the drug's price, which rose 18.7% in the U.S. on June 30, marking the most aggressive move since the drug's approval in 2004. There have only been two prior price increases: 1.5% a year ago and 8% last December. The price currently stands at $39,988 a year in the U.S.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; [email protected]