Replies to post #94177 on Biotech Values

[masterlongevity]

I didn't full weigh in, so will add some more.

The results would be considered modest for all other disease, but are pretty exciting for AD since nothing seems to work. The MRI data is the most compelling as baxter states. They still ahve a lot of supply issues to work out and one clinical trial to finish enrolling, plus another to start and finish.

What is interesting is that all the potential disease modfying AD drugs in ph 2 or 3 seem to be having severe delays enrolling their trials. Originally, bapineuzumab was suppsoed to have results due in mid 2010, but in recent bloomberg, it was stated that results will now be in 2012. That tells me that is taking them 3.5 yrs to enroll 1000 pt trials. that seems absurd considering the prevalence of this disease.

The order of competitors in the race seems to have shifter. Bapineuzumab did have a very clear lead, now not so much.

Based on all the info I ahve heard, here's approx. when the data will come out for the 4 products now in ph 3. 2012 will be a very busy and important year for AD

1) Lilly's gamma secretase inhibitor(trials are 21mos tx duration):
last patient enrolled in trial #1 (Sept 2009), resutls expected July 2011
last patient expected to be enrolled in trial #2 (June 2010), results expected April 2012

2) JnJ/Pfe Bapineuzumab(n-terminal passive antibody): JnJ has guided via bloomberg that results are expected in 2012: We will assume Jan 2012 until otherwise noted

3) Lilly's solaneuzumab (c-terminal passive antibody)(trials are 18 mos tx duration):
last patient expected to be enrolled in trial #1 (Sept 2010), results expected Apr 2012
last patient expected to be enrolled in trial #2 (Sept 2010), results expected April 2012

4) gammagard trial #1 still enrolling (18 months duration)
assume trial #1 to report Jan 2012
trial #2 not started: results probably not until 2014

[apljack]

BAX-Gammagard:

I read the results and had a couple of thoughts/questions including:

How frequent are the infusions? (there are several in trials right now, I believe, and the hassle of frequency will be telling.)

BAX provided a very small sample size and I have seen plenty of DAT studies with small sample size stat sig results that just disappear when the larger samples are taken.

This was a PR about results and I want to read the paper to see if/how many dropouts occurred to get to the 14 treated/7 control patients. The PR had general information about SE's but nothing about frequency for the study population.

Cortical atrophy/ventricular enlargement measures have not been part of the standard fare in the past and the data are intriguing, but the decline in ADAS scores for treatment patients are grossly in line with Aricept studies if memory serves. If you can get the same results with a daily oral med, then why go to all the fuss?

aj

[genisi]

BAX/Gammagard/Alzheimer’s: masterlongevity has mentioned the cost problem, which could be as high as $80k a year for the 400 mg/kg bodyweight every 2 weeks dose. Plasma volume supply is even a bigger problem.

[biomaven0]

>>Gammagard AD

I'd add that this is another "break the bank" and then some treatment - Gammagard is inherently extremely expensive to produce and administer and it's not even clear they could ramp up production by the two orders of magnitude or more (which would be needed if this were successful) even if they wanted to.

Incidentally Halozyme has a partnership w/ Baxter for an injectible form of Gammagard.

Peter