Amgen, Johnson & Johnson & The FDA

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CNBC.com

Shares of biotech giant Amgen fell as low as $43.14 (a new bottom) this morning after the briefing documents for Thursday's Food and Drug Administration Advisory Committee meeting were posted on the agency's website.

FYI: We're talkin' hundreds of pages of data.

Investors are apparently concerned about a possible worst-case scenario of the panel recommending the FDA prohibit use of Amgen's Aranesp and Johnson and Johnson's Procrit on cancer patients who get fatigued from chemo.

The J & J subsidiary that sells Procrit quickly put out a press release saying when the drug is properly used that it's safe and effective and has not been connected to an increased risk of death or tumor growth.

Ortho Biotech Products VP of Medical Affairs, Dr. Craig Tendler, is quoted as saying, "We hope that responsible recommendations will be made (by the FDA Advisory Committee) based on the totality of available evidence, including a substantial body of scientific data submitted to the FDA over the past several months."

And Amgen put out a slightly different worded statement. It did not use the words "safe" or "effective". The company says it "strongly believes that ESAs (the anemia drugs) provide an important clinical option for some patients, and looks forward to collaborating with the ODAC (the abbreviation for the FDA panel of outside experts) and FDA to maximize the benefits of these drugs when used according to the approved labeling while minimizing the risks."

And it goes on to warn about what might happen if the anemia drugs were not available to cancer patients.

"What is known is that if the ESA option were removed," the statement says, "more than twice as many patients receiving chemotherapy would require red blood cell transfusions...."

Rodman & Renshaw biotech analyst Mike King is out with a research note to clients based on the newly-posted FDA briefing documents. He writes that the papers "contain no surprises". King estimates there's a 10 percent chance the committee recommends anemia drugs be removed from cancer care and a 30 percent chance the panel advises the FDA to put restrictions on the drugs' use on patients with breast cancer that has spread.

While Geoffrey Porges at Sanford C. Bernstein writes, "Today's commentary from the FDA leaves little doubt that changes to the EPO (another abbreviation for the anemia drugs) label and use are on the way." He is telling clients to approach Thursday's meeting with "trepidation". (R & R and Bernstein make a market in AMGN).

The FDA panel will have 15 outside experts voting on this matter. That includes eight so-called temporary voting members. The FDA sometimes brings in extra people for big issues like this one. The meeting is scheduled to start at 8 a.m. ET and the vote will likely take place in the late afternoon. Again, these are recommendations which the agency often, but does not always follow. The FDA would possibly issue a final ruling within a month or two.

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