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Biotech Roundup: NDA as "Dialogue," One Year More for PCA Patients, Microcredit


One more year of life is a good thing...


NDA as "Dialogue"

Since the first PDUFA (Prescription Drug Fee User Act) was passed over a decade ago, there have been many improvements in methods of communication between the FDA and industry. In exchange for paying fees to the FDA, companies are guaranteed certain maximum response times as well as certain kinds of mandated meetings.

Pfizer (PFE) has apparently decided that filing a New Drug Application (NDA) is one form of opening dialogue with the agency. Please allow me to translate:

PfizerSpeak: "The torcetrapib marketing application based upon ultrasound data is meant to 'get the dialogue going' with the FDA."

Translation: "The FDA laughed us out of the room every time we proposed approval based upon ultrasound data, but if we don't file something shareholders are going to kill us."

Investors will get a look at some Lipitor + torcetrapib data the first week of November in patients with a genetic disease that causes them to have high levels of LDL. Data will be presented in Chicago at the America Heart Association meeting.

Wall Street is likely to descend on New Orleans in March of 2007 for the American College of Cardiology meeting. It is at this meeting where Pfizer will present the ultrasound data on the main large studies. I've been anxious to go back to New Orleans as I rather fell in love with the place, so my firm might join the crowd.

I still don't believe the data will be clinically relevant for morbidity and mortality. I happen to think the IVUS ultrasound is a legitimate way to analyze drugs for this indication, but I don't think the FDA will allow approval of torcetrapib until the hard morbidity and mortality data are available in 2009. Europe certainly will wait.

I expect the data to start leaking out (as in illegal insider trading leaks) after the first of the year as that's when Pfizer has to have the abstract in to ACC.

One Year More for PCA Patients

In a rather striking analysis released today, Dendreon (DNDN) announced its prostate cancer drug Provenge increased "cause-specific" survival in one of their pivotal Phase III studies by nearly a year (11.7 months). Survival trials are normally measured by "overall survival." Using overall survival, it doesn't matter what you died of in terms of the statistical analysis.

"Cause specific" survival uses only those patients who died of the target disease, in this case prostate cancer. It is arguably a more rigorous analysis when done correctly and in concert with a well-run and well-documented clinical trial.

I mention this not as an endorsement of Dendreon as an investment, though I've owned shares in the company for years, because the FDA's decision on Provenge approval next year is not as cut and dry as a one-year survival advantage would make it seem. I make the mention as a commentary on an emerging trend.

When I went to Paris last November for the ESMO cancer conference, I noticed most of the presentations included data on cause-specific mortality. This was different than the cancer conferences I normally attend in the US. When I attended ASCO last June, however, I noticed cause-specific mortality data was increasingly common.

I doubt the FDA will be falling all over themselves to switch from overall to cause-specific mortality as a matter of policy, but it might have an impact when it comes to product marketing. If a drug's cause-specific mortality is not as large as the overall survival – or not as large as a competing drug – then it could be a marketing problem.

I'll be keeping an eye on this to see how it develops.


I was overjoyed to see the man many credit as the father of microfinance receive a Nobel Prize recently. Muhammad Yunus has alternately been hailed as genius and a kook for his approach to helping people drag themselves out of poverty.

I went to a college perhaps not as well known as it should be for an exceptional political science faculty (Western Washington University). These ladies and gents are liberal… OK, bleeding heart liberal, so a "non-liberal" like me had an interesting time navigating the waters as I earned my poli‑sci minor. After being inundated with all the typical late-80s liberal stuff, I did take away a couple of truths about poverty I've held very close.

If you want to solve poverty, there are only two proven ways to do it:

1) Educate women to increase their social independence.
2) Microcredit.

It's no coincidence these two strategies often go hand in hand. If you look at most successful microfinance programs, most of the recipients are women. I'll also note neither of these approaches involves handouts, which only deepen the cycle of dependence and exacerbate social problems.

When the Feds announced the silly dividend tax cut, I advocated we turn that $80 bln (and counting) cost towards an adapted microfinance program here in the US. If we had $80 bln to spend on boosting the economy, I argued way back when, we should hand that over to a revamped SBA for distribution to small businesses. I still marvel that people gloss over the central lesson of the 1998-2000 economic boom in this country – namely that small businesses are better economic engines than large corporations. Skew part of that $80 bln into broad microfinance programs for depressed areas and inner cities and perhaps we could have done something about the growing gap between haves and have nots that will eventually rip this country apart. But I digress…

While microfinance is well accepted these days, it's not hard to imagine the look on the bankers' faces when Mr. Yunus went to them with his idea of loaning money to people who had no assets and no job. The world's a better place for Mr. Yunus ignoring those banker's dismissive attitudes and doing it on his own. I'm glad the Nobel committee saw fit to recognize this contribution.

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