Late yesterday afternoon, the Food and Drug Administration put out what it calls an "Early Communication" announcing that it's looking into possible dangerous side effects from Pfizer's hot, new smoking cessation pill, Chantix. The company sold nearly a quarter-billion dollars worth of the drug in the third quarter which put it on track to quickly achieve billion-dollar blockbuster status.
It's an important growth-driver for PFE. A Pfizer spokesperson tells "The Wall Street Journal" that four million people in this country have taken Chantix. Well, in some of CNBC's copy yesterday we apparently referred to the "Early Communication" as a "warning" from the FDA. And a Pfizer spokesman took issue with that. He left me a voicemail message asking us to stop using the word "warning" in reference to the agency's "Early Communication" to doctors and patients to be on the lookout for suicidal thoughts, erratic behavior and drowsiness among those taking Chantix.
While the "Early Communication" (a term no one outside the FDA would understand) does not constitute a formal warning, the agency is still essentially warning people to be vigilant about monitoring Chantix patients. And although the WSJ also reports that Pfizer is trying to get out in front of this by already adding the potential side effect information to the Chantix label, some analysts believe the FDA probe will probably lead to an even stronger warning and quite possibly a dreaded "Black Box" or severe safety warning.
Regardless, analysts believe the publicity alone about the suspected side effects will hurt sales growth of this previously fast-growing product. However, the FDA says there's no evidence of a cause and effect.
A couple of months agoI did a report on the high-profile casethat led to the FDA review. I had heard about the story and thought about doing something on it, but elected to take a wait-and-see because it was anecdotal and somewhat circumstantial.
But after I saw it featured prominently on ABC's "Good Morning America", I figured we'd better jump on it since that would likely lead to more of what we in the news biz refer to as "mainstream media" coverage. The case was getting a lot of press in the Dallas metroplex because the victim was a popular local musician who once played keyboards for "Edie Brickell and the New Bohemians" who had the hit, "What I Am". An autopsy reportedly showed that Carter Albrecht was drunk. You shouldn't mix alcohol with prescription drugs, especially one like Chantix which works on the central nervous system.
In early trading, PFE shares are down again flirting with another new low. But it's not just about Chantix. Obviously, the markets are down and most of the big pharma sector is down. But Pfizer is also dealing with falling sales of Lipitor, the recent abandonment of a once-promising diabetes drug, the looming Lipitor patent expiration and nothing visible in its drug development pipeline to replace it.
Last Friday, it did a chump-change acquisition. But most analysts say it's gonna take a lot more than that to light a fire under PFE shares and that the company needs to put its approximately $23 billion in cash and its borrowing power to work on a big deal. Biogen-Idec is for sale.
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