|Biogen will alert Drs. on a password protected website regarding further cases of PML. Investors have to contact IR. Another system skewed towards firms with medical consultants. Mid month. I suspect IR is going to be very, very, busy then. Another thing one could monitor would be large put buys on Elan and Biogen at those times . . .|
>>Biogen Revises Brain Infection Disclosure Policy For Tysabri
Last update: 1/22/2010 2:32:30 PM
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) will communicate with doctors once a month on the occurrence of new cases of a rare brain infection in patients using its multiple sclerosis treatment Tysabri, as the biotech strives to find the right balance in keeping the medical and financial communities updated on that important number.
The situation is closely watched because Tysabri, a highly effective treatment sold with Elan Corp. (ELN), was previously pulled from the market because of its association with progressive multifocal leukoencephalopathy, or PML, a debilitating and often fatal condition. The infection rate has hurt the sales growth of the drug, which is key to Biogen's future and is Elan's biggest seller.
Since its re-emergence in 2008, Biogen and regulators have struggled with how to provide information on PML because case-by-case updates of a specific side effect are unprecedented. Last summer, the Cambridge, Mass., company stopped providing updates altogether.
As of mid-January, the number of cases stands at 31, which puts the overall incidence rate at about 1-in-1,000 patients, as implied by the drug's label.
Under the new plan, Biogen will proactively update physicians midmonth and provide information through a password-protected Web site. It will include the number of PML cases, with an incidence rate broken down by duration of use, as well as a cumulative patient exposure figure, which is different then the quarterly patient count provided to investors.
Investors can get the same information from investor relations, although the company won't be posting it on a public web site or making an announcement.
Patient services will provide Tysabri users with information upon request, although not with the level of detail given to physicians, or even to investors.
The reason for the disparity between how doctors and patients are updated is because of regulations that restrict direct interactions between patients and drug companies, because those communications could be deemed as promotional activities and thus need to be cleared with regulators.
Major developments would be communicated outside of the regular updates and regulators will continue to receive information on a realtime basis.
Biogen withdrew the drug from the market for 18 months beginning in 2005 after three patients developed PML. Infections re-emerged in 2008, and Biogen provided regular weekly updates to the public until last July, when it officially stopped providing any information.
In October, European and U.S. regulators said the number of PML cases had risen to 24, well above Biogen's July disclosure of 11, surprising Wall Street and raising questions about Biogen's disclosure policies and refusal to comment on PML case numbers. The company began to re-think its approach at about the same time.
"We just realized that that just wasn't going to work," said Biogen spokeswoman Naomi Aoki, who noted that information about new cases continued to become public through other sources despite the company's decision to not comment.
"It fueled a greater fear factor than being consistently transparent about the information," she said. "This [change] is driven by what the medical community needs and wants."
On Thursday, the European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, recommended increased risk-mitigation measures for Tysabri after reviewing its safety. The panel concluded that Tysabri's benefit for MS patients outweighs its risks and the drug should stay on the market.
Tysabri had more than $1 billion in 2009 sales, but its controversial history has provoked fear in investors and confusion about the disclosure of new cases hasn't helped.
Biogen's stock was up 12% in 2009 and Elan rose 9%, compared with a 23% rise in the S&P 500, and both stocks saw plenty of Tysabri-related volatility. This month, Biogen Chief Executive James Mullen said the share price has been "bound by uncertainty over Tysabri."<<