RE: NEUROCHEM ALZHEMED RESULTS..........polak
Hey Polak......thought you would find this interesting........
.....Neurochem Down for the Count?
By Brian Lawler August 27, 2007
Drug developer Neurochem (Nasdaq: NRMX) has finally announced results of a phase 3 study of Alzheimer's disease treatment Alzhemed, and investors are not being rewarded for patience. They're looking at a bare drug pipeline and a couple of big setbacks.
After numerous delays since it first planned to announce the study results in April, giving management time to do $80 million in financing, Neurochem announced Sunday that Alzhemed did not successfully meet any of its disease-modifying or other primary endpoints in the 18-month study that enrolled 1,052 patients.
Neurochem also did not release any numerical data on the compound, with the dubious excuse that the model used to collect the data was unreliable. This should make investors look at Neurochem in a very skeptical light, as it's easy for drugmakers to withhold the magnitude of how bad their data may be by simply not releasing the numerical results.
Running clinical trials to test drugs against Alzheimer's disease and other neurodegenerative disorders is notoriously difficult, as drugmakers including Myriad Genetics (Nasdaq: MYGN) or Wyeth (NYSE: WYE) can attest. This means that the bar for a successful study isn't as high at the FDA and other worldwide regulatory agencies.
Undoubtedly this failed study will hurt Neurochem's chances at signing a good (or any) partnership deal for Alzhemed, as the company was discussing earlier in the year. However, an ongoing European phase 3 study holds out one more chance for the drug. It could be another two years before data is released on this study, but Neurochem mentioned today that it may modify that study in light of the Alzhemed results.
With likely two failed compounds -- since the FDA rejected Neurochem's amyloidosis compound Kiacta a second time in July -- it's hard to see much value in shares of the company, considering its bare drug pipeline. Even at a market cap of $200 million and change, shares have plenty of room to fall.
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Neurochem down 43.1% yesterday from fridays close......down 25.95% today to close at $2.34. NRMX is currently trading down at $2.30 in After Hours Trading.
Goes to show how juggling the statistical data can sink you in the end. The data was IMO manipulated in the PhaseII study that Neurochem ran to justify advancing Alzhemed into its pivotal Phase III program.
After three months of treatment, there was no difference in cognitive function, memory performance or any other efficacy measure between the Alzhemed and Placebo Patients......... so Neurochem extended the Phasell Study.
All patients, including those previously on placebo, were invited to participate in an open-label, single-arm extension study using the higher 300 mg dose. Because all patients in this extension study were on Alzhemed, there was no real control arm for comparison. Then, Neurochem decided to make the comparisons using previously published data from other Alzheimer's disease trials in 1994........this data is essentially corrupt because it excludes patients who were performing poorly on Alzhemed. Of the 42 patients who started the extension study, 18 -- or 43% -- had dropped out by 20 months.........But the dropped patients weren't included in the efficacy analysis. At least six of these dropped patients stopped taking Alzhemed because of "perceived lack of efficacy." Excluding these patients from the Final Data made Alzhemed appear more efficacious than it really is. So then on to the Phaselll Studys and where Alzhemed sits today.
As mentioned before the Neurochem Alzhemed Studys will be looked upon as a 'Case Study' of 'How Not To Conduct and Analyze Clinical Trials'!!!
That Polak in a nutshell is additional strong reasoning of why the Alzhemed failure should not greatly affect Transitions valuation for Alzheimers potential BlockBuster Drug AZD-103.........unless of course Dr. Cruz joins the circus to learn how to juggle like that!.......LOL!
I think you're right......Good for TTH.