NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) disclosed Friday that a sixth multiple-sclerosis patient on Tysabri has developed a rare brain infection since the drug was reintroduced on the market in July 2006.
Despite the addition, the ratio of patients that have contracted progressive multifocal leukoencephalopathy, or PML, remains within the ratio outlined on the drug's label.
Tysabri - sold by the Cambridge, Mass., biotech with Ireland-based partner Elan Corp. PLC (ELN) - was pulled from the market for 18 months beginning in 2005 because of a suspected link to the rare brain infection. Before Friday, the company had reported five confirmed cases, with one death, since the relaunch.
The latest case was outside the U.S., as were four of the previous five. Biogen didn't disclose additional details on the patient's condition.
Biogen plans to post a case update every Friday until July 24, the third anniversary of relaunch, by which time it expects the risk/benefit profile to be clearer.
The PML rate implied on Tysabri's label is one-per-1,000 patients. As of the end of March, about 40,000 patients were using Tysabri and about 24,900 patients have received at least one year of therapy. Chief Executive Jim Mullen, before Friday, had stressed the current rate for patients taking the drug more than 12 months is about one-per-4,000.
Some believe that duration of therapy plays a role in Tysabri's PML risk. The company said Thursday that about 6,800 patients have used the drug for more than two years, which is a rise of 2,500 from three months ago.
Following news of the latest case, Biogen shares slipped 9 cents to $50 in after-hours trading.
The PML report comes a day after Biogen's first-quarter profit soared 50% as lower expenses helped overcome disappointing sales.
Revenue from sales of Tysabri rose to $165 million in the quarter from $115 million a year ago. Global "in-market" sales of Tysabri were $227 million for the period, which fell below a Wall Street consensus estimate of $246 million, according to Cowen & Co.
Biogen has been attempting to re-accelerate growth of Tysabri by stressing patient benefits and the drug's better-than-expected risk profile.
Earlier this year, Biogen retreated from its long-held goal to reach 100,000 patients on Tysabri by the end of 2010.
By George Stahl, Dow Jones Newswires, 201-938-5153, george.stahl@dowjones,com
(END) Dow Jones Newswires
Copyright (c) 2009 Dow Jones & Company, Inc.
And if BIIB get 100% Ty, I bet BIIB will announce way to prevent PML to happen and patient # will incrase skyrocket..
this is all BIIB's game plan, and ELN is being PLAYED.
I think ELN will be bought soon...
nah-there is no certain way to "prevent" pml but there are ways to diagnose it early and treat it if you are one of the unlucky few who get it. Remember we know cases of pml will pop up but do they eclipse the 1/1000 which is stated on the label. 6 out of 40,000 is a far cry from even what the label suggests. Still the media will do what they do. Furthermore I thought biib was doing a friday afternoon pml watch so how does the boston globe "scoop" them? IMHO BBBud
How about those few thousand patients were in the trials before Ty approved by FDA, those patients use Ty for more than 5 years. If your theory is true, then those patients would all get PML by now.