Elan's Headed in the Right Direction

• Report this Comment On October 23, 2009, at 3:15 PM, oflynnc wrote:

  Shocker performance today....the whole issue with PML just wont go away....

• Report this Comment On October 23, 2009, at 4:39 PM, TMFBiologyFool wrote:

  Yep, the headline isn't really appropriate for today is it? I'll have my take on Monday.

  -Brian

• Report this Comment On October 25, 2009, at 6:05 AM, oflynnc wrote:

  This is commentary from an Irish broker - I think its a glass half-empty commentary, a lot of if's and maybe's:

  Number of PML cases quoted by EMEA a concern.

  EMEA starting a risk benefit analysis on Tysabri

  The European Medicines Agency (EMEA) has announced that it is starting a review of the benefits and risks of Tysabri. The committee is discussing "any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment". This in itself might have been expected, given that there would appear to be the possibility, as noted by t he US FDA, of a link between length of exposure to the drug and increased risk.

  Now 23 cases of PML reported ...

  What is unexpected, and negative for the drug and Elan, is that this step is being taken after reports of 23 cases of PML worldwide since Tysabri has been back on the market.

  ... which is a large increase on the 13 noted by the FDA in mid-September

  When Biogen Idec stopped reporting cases on a weekly basis at the end of June 2009 there were 11 cases worldwide. The FDA then issued an update on 17 September, where it noted there were 13 cases. Since Biogen Idec stopped reporting, the number of cases has jumped 109% over a four month period.

  Patient profile not yet known

  No details are yet available on the geographic location of the patients, how long they had been on Tysabri, their current condition or any other predisposing conditions.

  If new cases are in longer-term patients, then FDA acceptable risk limits are under pressure

  That said, if all 10 new cases (plus the two reported in September) were in patients on the drug over 24 months, it would bring the ratio within that exposure group to 1 in 705, on Q309 updated numbers (19 out of 13,400). This is well below the overall acceptable risk rate indicated by the FDA as one in 1,000.

  13,400 patients on Tysabri for at least 24 months

  As a reminder, the exposure profile to Tysabri as of September 2009 is:

  At least one year - 34,400

  At least 18 months - 23,000

  At least 24 months - 13,400

  At least 30 months - 6,400

  Tysabri the main driver for Elan in the short to mid-term

  We have Tysabri generating revenue of $1.2bn for Elan in FY10 (75% of total revenue). Any pull back on expectations which could be driven by imposition of further conditions on the sale of the drug both in the US and ex-US (e.g. limits on length of drug exposure, requirement for drug holidays, implementation of safety programmes in the EU) would have a material impact on Elan. At this stage, a 10% drop in FY10 Tysabri revenue could roughly half reported earnings.

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