Feuerstein's Biotech-Stock Mailbag

Not more than 15 minutes after I posted Wyeth, Elan Halt Alzheimer Drug Trial, a short news brief Thursday about Elan and Wyeth WYE suspending a clinical trial of experimental Alzheimer drug ACC-001, I received an email from Vince N., who chided me with the following:

I hope you never have a loved one with Alzheimer's, with such an ambiguous headline designed, it seems, to create panic. Are you as a journalist reporting the news or are you the news? As you already know, AAC-001 is the vaccine trial ... neither of these trials have anything to do with the lead bapineuzumab trial.

Peter, you see what I mean? Cult stock!

But then, I received this email from C.B.,

Thank you for the quick and accurate report on the ACC-001 suspension. Although I am a self-confessed Elaniac, I differ with most in that I think you only try to express unbiased opinions and try to get us to see through the Kool-Aid haze that most holders of Elan have. Nonetheless, I appreciate the quick, comprehensive and succinct item on the ACC-001 trial suspension and making it clear that this has nothing to do with the much more important [bapineuzumab] trials. Again, don't let the more rabid Elaniacs bother you.

Thanks a lot, C.B. I just hope they don't banish her from the cult for saying nice things about me.

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My cautious comments last week on Generex Biotechnology GNBT didn't sit well with quite a few readers. I'll stand by what I said. On a related note, Randall P. asks, "You say in your article that Generex isn't the only drug company developing an oral insulin product. Can you tell me what the names of the other companies that are doing this? I ask because I just don't know of any others."

Emisphere EMIS is trying to develop an insulin pill, as is Diabetology, which has an insulin pill candidate called Capsulin.

There are a couple of intranasal insulin products (not exactly oral, but close) in testing from Nastech Pharmaceuticals NSTK and Bentley Pharmaceuticals BNT. Lastly Biodel BIOD has a sublingual version of insulin called Viatab. (Credit, as always, to BioMedTracker.com for helping me research these companies quickly.)

Do I have any great confidence one or more of these products will be successful? Not really. Oral delivery of insulin is tough. If it were easy, the major players in the diabetes market would be all over the technology. They're not, which tells you something important.

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Joy C. took great joy from How to Review Biotech Clinical Data, a column I wrote The subtext of the column was how Introgen Therapeutics INGN is one again misleading investors.

Joy writes:

I'm in the biz and have created more posters for scientific meetings than I can count. The title of your article caught my eye, and I found it very well written.

I looked at the poster for fun, and I'll tell you what it looks like to me -- I think they are laying the foundation to justify a non-significant result in the intent-to-treat population with a subgroup they are defining that seems to do better. I don't have to tell you this could be random.

I also liked that trick of layering at least four subgroups in the Kaplan-Meyer plot, bolding the line they want you to see. No doubt the Ns in each of these subgroups was so small as to make an interpretation of the results clinically irrelevant. They'll have to complete a prospectively designed study in their so-called favorable patients to propose any claims of efficacy.

Mark my words -- watch for a final report focusing almost entirely on this favorable P53 subgroup, which I venture to guess wasn't defined as the primary objective in the protocol. Bad science makes me mad. It makes us all look like scumbags, and we're not. Keep up the good work!

I couldn't have said it better myself, Joy, so I won't even try. Well done.

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Onward to Dendreon DNDN. This from Robert C.: "Adam, with the most recent news out on Dendreon, there seem to be mixed opinions on whether this news is good or bad for the company. Any chance you can share your opinion on this?"

Me? Share on opinion on Dendreon? You know I'm hesitant to do that...

Dendreon raised $47 million from a single institutional investor on April 3, which bought 8 million shares at $5.92 a share. The investor also got warrants for another 8 million shares with an exercise price of $20 a share.

Any time a biotech company can raise money in this market environment on neutral terms, it's a positive. So, Dendreon has more cash in the bank, and the dilution won't matter much if Provenge turns out to be a success.

But I don't think you can read too much into this investment regarding the odds for a positive outcome for the ongoing Provenge trial. The stock hasn't done much since the investment was announced, so I think that's what the market is telling you too.

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1 What would best describe your stance heading into the coming week of trading? Bullish Bearish Neutral 2 Which of these sectors do you think is set to move up in the coming week? --Choose One--Aerospace and DefenseAirlinesAutomobilesBeverages and Food ProductsBiotechnologyCommercial BanksComputers and PeripheralsConsumer NondurablesEnergy Equipment & ServicesHMOs and HospitalsHomebuildingInsuranceIntegrated OilInternet, Software ServicesInvestment Bankers and BrokersMediaMultiline RetailPharmaceuticalsPrecious MetalsSemis, Semi EquipmentTelecom EquipmentTobacco and AlcoholWireless CommunicationsUtilities 3 Which of these sectors do you think is set to move down in the coming week? --Choose One--Aerospace and DefenseAirlinesAutomobilesBeverages and Food ProductsBiotechnologyCommercial BanksComputers and PeripheralsConsumer NondurablesEnergy Equipment & ServicesHMOs and HospitalsHomebuildingInsuranceIntegrated OilInternet, Software ServicesInvestment Bankers and BrokersMediaMultiline RetailPharmaceuticalsPrecious MetalsSemis, Semi EquipmentTelecom EquipmentTobacco and AlcoholWireless CommunicationsUtilities View the results without voting