Feuerstein's Biotech-Stock Mailbag

Well, to move things along, I thought it worthy to bring to everyone's attention another scientific article -- an editorial, to be more precise -- published in the July issue of Nature Clinical Practice Oncology. It's titled "The Provenge Decision," authored by Vincent DeVita Jr., editor in chief of the publication.

Excuse me as I quote from DeVita at some length:

"The real question is not why the FDA failed to approve the vaccine, but rather why they agreed to review the data in the first place. The furor surrounding the FDA decision perhaps informs us. Winston Churchill was fond of saying that wherever there is free speech, there is also a lot of foolish speech, and this was certainly the case before and after the FDA decision."

DeVita goes on to write:

"I am normally very much in favor of patients having access to drugs that show promise, but are not yet approved by the FDA. So, what is the harm here for approving a fairly nontoxic vaccine like Provenge?

"The harm is twofold. First, the promise of Provenge does not derive from positive data in the two studies presented. It derives from the attractive concept of having a vaccine that will stimulate the patient's immune system. That is a dangerous precedent. There are actually other drugs in the pipeline that show more promise, at the moment, than Provenge in patients with advanced prostate cancer.

"The second difficulty derives from the fact that the FDA has unfortunately assumed the role of the oncologist of last resort. In approving Provenge, it would establish a new standard of care and force all other new therapies into head-to-head trials for their approval. This situation would slow, not accelerate, the development of new drugs."

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I'm trying to work on new companies, but the holidays, Dendreon and my looming move across the country are getting in my way. So, let me touch briefly on Amicus Therapeutics (FOLD) after speaking with CEO John Crowley last week, with the promise of more in-depth coverage later. I think this is a stock that should be on your biotech radar screen.

Amicus went public in May and, in typical biotech fashion, quickly fell below its IPO price of $15. The stock now trades around $12. That might change come Monday when the restrictions are lifted on sell-side research. It won't surprise me to see some positive initiation reports soon from Merrill Lynch, Morgan Stanley and the other underwriters of Amicus' IPO.

Amicus is developing drugs for genetic diseases based on a technology that it calls "pharmacological chaperones." Let me try to briefly explain: Many genetic diseases are caused by misshaped or defective proteins that are less stable or have reduced biological activity. If these faulty proteins pile up inside a cell, they can lead to impaired cellular function and disease.

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