Biogen Plans To Post Weekly Updates On Brain Infection Cases
The decision for the move, disclosed by Chief Executive James Mullen at a Goldman Sachs Healthcare conference in New York on Wednesday, is an effort to move to a more consistent disclosure policy of the often fatal condition.
A suspected link to progressive multifocal leukoencephalopathy, or PML, led to Tysabri being pulled from the market for 18 months beginning in 2005. Since the relaunch, the company has reported that four people had confirmed cases of PML with one dying.
This past summer marked the two-year anniversary of Tysabri's re-launch, raising Wall Street's anxiety over PML-related news. The timeline is important because two patients with PML in 2005 were using the drug for more than two years.
Biogen will post an update of PML cases on the investor relations section of its Web site every Friday, beginning this week, at 4:30 p.m. EST and will continue to do so until July 24, which is the third anniversary of the drug's relaunch.
"At that point, people should have a clearer picture of the risk/benefit profile," said Biogen spokeswoman Naomi Aoki, who noted that after July the company will continue to provide in-depth safety updates at medical meetings.
Biogen had previously reported confirmed PML cases though 8-K filings with the Securities and Exchange Commission.
The Web site will list the date that PML was confirmed, how long the patient used the drug, whether it was in the U.S. or overseas, and whether Tysabri was used for MS or Crohn's disease, which is another approved use of the drug.
No updates on the status of the patients will be provided.
Tysabri is Biogen's key growth driver and its growth is closely watched by Wall Street, as is its stated goal of 100,000 patients in 2010.
Some have questioned Biogen's ability to hit that goal and Mullen has conceded that Tysabri's growth will need to accelerate to hit the target.
Biogen will continue to update the patient usage data on the drug on a quarterly basis, Mullen said.
As of Sept. 30, more than 35,500 patients use Tysabri, with 9,500 patients on it for at least 18 months and 3,700 for more than two years.
Separately, Mullen said Wall Street's long-term earnings projections for the company are below its previous guidance due to a "much more bullish view" of Tysabri's growth in comparison to Wall Street analysts.
"The Street has been chronically lower than what we actually deliver," he said.
Biogen has consistently projected 20% non-GAAP EPS growth through 2010, while a Thomson Reuters analyst survey produced a consensus for 9% growth in 2009 and 7% in 2010.
Shares of Biogen closed Tuesday up 34 cents, or 0.7%, at $46.81. Elan shares fell 7 cents, or 0.9%, to $7.59. Both shares are unchanged in recent late trading.
-By Thomas Gryta, Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com
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Publié le 07 janvier 2009 Copyright © 2009 Dowjones
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