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Friday Biotech Roundup


You in the hat, get a real job!


Genta decision anti-climactic for biotech

(GNTA) had its day in front of the FDA's Oncology Drug Advisory Committee (ODAC) and failed a second time. As I expected, however, this did not have the same impact on the biotech sector as their May 2004 failure. That's a good thing, because basing the future of the sector a second time on an ODAC decision on Genasense would give me the willies.

The ODAC panel wasn't exactly fair, but the behavior of Oncology Division head Dr. Richard Pazdur wasn't as egregious this time. In 2004, he punted nearly all of the sitting panel members to get the group he needed to turn down the drug. This time he simply didn't bother to add panel members with any expertise in the disease in question. Well, the industry representative has experience treating CLL but he didn't get a vote and they changed the rules on him so he couldn't give his opinion when he normally does.

We might have a biotech pivot point Q1-2007 via an FDA panel on Dendreon's (DNDN) prostate cancer drug Provenge, but it will depend on how the players are positioned at that time. I'll keep you posted on this aspect of that panel, but it is looking to shape up as a failure would be business-as-usual and a success would boost the sector. We'll see how the players are aligned when we get closer.

We don't like you, so shoo!

The Wall Street Journal reported rather amazing story this week about how Oscient (OSCI) was able to remove biostatistician Dr. Thomas Fleming from their advisory panel for the antibiotic Factive. Dr. Fleming is one of the most influential biostatisticians in the FDA regulatory process and has been a fixture on FDA advisory panels for years.

Oscient's problem was that Dr. Fleming has spoken out against the trial design they used. He also worked with a predecessor company to Oscient, but that's not what got him kicked off. Oscient asked him to be removed because of his views on non-inferiority trials for antibiotics – which was the basis for the Factive application.

A non-inferiority trial simply tells you that one drug is not significantly less effective than another. That's great, as long as you are sure the comparator drug is effective. Dr. Fleming has long believed that the trials for some of the earlier antibiotics were flawed and that they might not be more effective than sugar pills. If he's right, then doing a non-inferiority trial only ensures that you have two ineffective drugs on the market.

I admire, I guess, Oscient's approach. If I owned the stock, though, I would have bailed because such an action is sure to anger the panel and make it harder for you to get your drug passed. It's a damned if you do, damned if you don't situation for sure.

I usually don't agree with Dr. Fleming's didactic approach to biostatistics, but I wouldn't consider him "biased". I tend to think this one backfired on Oscient.

Real job?

When you are flying back and forth across the country, it is amazing how far you can fall behind even when you're working on the plane. I haven't had this many meetings in a week since I last had a real job almost a decade ago.

"Real job?" Yeah. When we started this biotech trek five years ago, my Dad would always (jokingly) ask me when I was going to quit and get a real job. He wasn't certain writing for a living, particularly about the stock market, was a productive use of anyone's time – particularly his son's.

Dad started working in his parents' gas station and tavern early, was driving truck in an iron ore mine by his teens, did a stint in the US Air Force, and, by 1948, landed a job at the last employer he would ever have. He spent the next 42 years at Grays Harbor Paper Company, first as a union shift worker. He was one of the founders of the AWPPW union, in fact. After I was born, he went to work on the management side as the Industrial Relations and Personnel manager – a desk job with regular hours.

I worked summers at the paper mill to help pay for my college. Far earlier than that, I learned carpentry skills (and how to drive a forklift!) helping Dad build the company's parade float.

You've probably already figured out this has nothing to do with biotech, but I couldn't help remembering this as I read the news Ford (F) is jettisoning 75,000 employees as a first step in rebuilding America's finest auto maker.

I think my Dad's comment about how the market is not a "real job" is instructive, too. I was sitting around with some friends the other day and they were recounting how many people they have worked for. I was definitely at the low end with four, despite the fact I was the oldest one in the group. One 33-year-old had a dozen jobs on her resume already.

I asked them what they believed America's core business competency was – what we were doing now so much better than everyone else that we had a great competitive advantage. Nobody in the group could come up with any major industry where we dominated, except in the financial services arena (I would argue biotech, but then I'm biased). While there are many other markets, generally if you want access to the most capital you need to come to the US still.

It's no wonder regulators are protective of our capital markets. The inevitable tide of globalization has eroded most of our other industries.

I wonder how many of those 75,000 workers that will lose their jobs at Ford will be able to adapt now that a "real job" is nothing more than moving money around inside a big computer network.

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