Biotech Notebook: Progenics, Wyeth

Granted, there is a lot of guessing in this model, but then, there always is when you're trying to predict the future value of a newly marketed drug. But what I like about my source's arithmetic is that he's only assuming Relistor use in hospice patients, which is conservative since there are plenty of other critically ill patients.

In this calculation, there is no value at all given to Relistor being approved in other indications, nor is Progenics getting credit for a pipeline that includes an interesting, albeit early, HIV drug. All that would be upside.

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Wyeth is getting ready to start one of two phase III clinical trials of the Alzheimer's drug bapineuzumab it is responsible for under its partnership with Irish drugmaker Elan ELN. (Elan already announced the start of its two phase III studies of bapineuzumb.)

You can find a listing of the Wyeth study, posted April 29, on the ClinicalTrials.gov Web site.

What I find interesting is that Wyeth disclosed the primary and secondary endpoints of the bapineuzumab study, and lo and behold, the primary cognitive endpoint is a change in the ADAS-cog scale.

But what happened to the highly praised and supposedly more sensitive Neuropsychological Test Battery, or NTB, that's supposed to be all the rage in Alzheimer's research circles? According to this posting, it's listed as a lowly secondary efficacy endpoint.

Wyeth is responsible for the European clinical trials of bapineuzumab, while Elan is conducting its work in the U.S. Could it be that European regulators aren't as sanguine with the never-before-used and not-so-independently-validated NTB measurement tool?

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A top manufacturing executive left Introgen Therapeutics INGN late last year, but the company never disclosed his departure to investors.

Peter Clarke, Introgen's vice president of production and technical processes, was missing from the company's "Significant Employees" list contained in its annual proxy statement filed with the Securities and Exchange Commission on April 29.

Clarke was listed as a significant employee in last year's proxy statement. When asked why he wasn't mentioned in this year's filing, Introgen spokeswoman Channing Burke said, in an email, that Clarke left the company around October or November 2007. The reason for his departure wasn't disclosed.