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 Biotech / Medical | Elan Corporation, plc (ELN)

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To: Robohogs who wrote (9360)5/21/2007 12:00:57 PM
From: Robohogs   of 10345
 
Natexis Successful Ph II could be worth $15 by itself given mkt size. Must be element of trust until data release. Target to 26 from 16.

Keys to move:

Data must have been overwhelming
Unwise to take move to save 6-10 months unless data great
Trials require hefty expenses and better to have better data unless Ph II very good

They assume approval in 2010. Use 25K per year per patient and only 20-25% discount rate.

They do have 3.5 billion in T revenue in 2019 by the way.

Davy - believes intention is for Ph II to remain pivotal. Target to 21 from 16.

AGE - could file in 2009. Keep hold rating.

Citi - could be on market by 2009. 12 target. Risks remain.

Jon

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To: J Stone who wrote (9361)5/21/2007 12:02:00 PM
From: Robohogs   of 10345
 
Why PH II likely going to end in late 2007 to be used for filing with PH III to fill in data or be used after approval.

Jon

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To: Robohogs who wrote (9360)5/21/2007 12:12:01 PM
From: quidditch   of 10345
 
Jon, I haven't seen or heard of Feuerstein's piece. Where is it on the web?

quid

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To: quidditch who wrote (9365)5/21/2007 12:21:02 PM
From: Robohogs   of 10345
 
he is the one good thing about street.com. See below.

Adam Feuerstein
Elan, Wyeth move Alzheimer's drug to phase III trial
5/21/2007 8:35 AM EDT



Elan and

Wyeth have decided to advance their Alzheimer's drug Bapineuzimab (AAB-001) into a phase III trial. Elan is rallying on this news, no surprise there, but also as expected, the companies are giving us zero information about how the drug performed in the ongoing phase II studies. Therefore, it's exceedingly difficult to assess the risk of this program.

How did Elan and Wyeth decided to push forward with Bapineuzimab? According to this morning's press release, "This decision was based on the seriousness of the disease and the totality of what the companies have learned from their immunotherapy programs, including a scheduled Interim look at data from an ongoing Phase 2 study, which remains blinded."

Also, "No conclusion about the Phase 2 study can be drawn until the study is completed and the final data are analyzed and released in 2008."

Not exactly a ringing endorsement! That's a very oddly worded press release. I'm guessing the companies are seeing some whiff of efficacy from the phase II studies and the drug is safe. But if there was more to the drug to give the companies a lot of confidence, you'd think they would have said so. They didn't.

Remember that Alzheimer's disease trials are the riskiest of high-risk events.

Position: none

Pay service so link no good but here it is.

thestreet.com 

Jon

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To: Robohogs who wrote (9366)5/21/2007 12:40:01 PM
From: fred hayes   of 10345
 
Jon, ya, I like him too, but I think making a big deal about not providing more P2 data is off base here. Elan has made it very clear that they would not be releasing data until next year in the event they decided to go to early P3, so implying that more detail should have been given is a little unfair. I'm sticking to the basics. Very good news, but the program has many unknowns and a long ways to go. And I emphasize "program", not just this particular drug.

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To: quidditch who wrote (9356)5/21/2007 2:22:18 PM
From: Harold Engstrom   of 10345
 
quidditch, the companies have definitely seen the data but not the unblinded data. So, basically, they can see that 50% of patients have seen there MMSEs and ADAS-cog scores improve and stabilize and 50% decline dramatically for the first 3 cohorts. (The 4th - 2.0mg/kg - cohort is only at the mid-way point.)

I expect that that blinded data is incredibly compelling. I expect this because lead investigators like Reisa Sperling are saying so in their talks around the country - or at least hinting strongly at it. The is zero chance that Wyeth pulls the trigger on a P3 and its huge expense, or that Elan does the same, without this being a "slam dunk."

IMO, this is game over for Biogen with respect to being able to purchase Elan. And, simultaneously, the game is on with respect to Wyeth wooing Elan. IMO the penny drops with Wall Street over the coming weeks and Elan begins to soar.

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To: quidditch who wrote (9358)5/21/2007 2:23:00 PM
From: Lee39   of 10345
 
the SAE were a rare brain fever, no patient died from it .

However autospies of patients (who died from other causes ) shows nice amyloid clearance,
and tracking of patients shows great results from the prior generation drug.

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To: fred hayes who wrote (9367)5/21/2007 2:24:54 PM
From: Harold Engstrom   of 10345
 
Fred, IMO after 270 patients, 2+ years for many of them, there are many fewer unknowns here. Elan is now, in my opinion, on its way to either becoming a tier one pharmaceutical company or being acquired. H

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To: J Stone who wrote (9361)5/21/2007 2:24:57 PM
From: Lee39   of 10345
 
data from ongoing ph 2 trial remains blinded,
only reason is possiblity it may be used as pivotal trial data to support a drug application.

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To: Lee39 who wrote (9371)5/21/2007 3:53:10 PM
From: Harold Engstrom   of 10345
 
Exactly Lee.

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