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Ahead of the big Food and Drug Administration Advisory Committee meeting tomorrow, Amgen held a quick conference call with some reporters this afternoon. The outside panel of experts will be deciding whether to recommend putting more restrictions on the use of the blockbuster drugs used to fight anemia in cancer patients getting chemo. For Johnson and Johnson [JNJ
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So, the biotech company gave reporters around 20-25 minutes to listen to and then question its head of research and development, Dr. Roger Perlmutter.
But there was one small glitch: Dr. Perlmutter was calling in on a cell phone and at one point he apparently hit a dead zone and dropped out. Three to four minutes later, he reestablished contact. This left only enough time for -- by my count -- four reporters to ask questions. I don't know how many were listening in or in the queue. He didn't disclose his whereabouts. I'm assuming somewhere between Reagan National or Dulles and beautiful "downtown" Gaithersburg, Md., where the meeting is being held tomorrow.
Anyway, Dr. Perlmutter repeated at least three times that he believes the benefits of Amgen's drugs for chemo-induced anemia are "unambiguous," particularly when it comes to avoiding the alternative -- blood transfusions. And he said he thinks that in the 59 studies that have been done, the observation of tumor growth in cancer patients receiving the anemia drugs has been "inconsistent."
Dr. Perlmutter tipped his hand a little bit by revealing that the company will make "suggestions" to the committee about how it thinks the situation should be handled. One reporter pressed him to divulge the ideas, but that's when the call dropped out. So another Amgen executive, Dr. Joseph Miletich, senior VP of research and preclinical Development, picked up the ball and said, "We don't want to appear to be having a pre-discussion before the meeting."
There are several scenarios that could play out tomorrow. I'll be watching the Webcast of the meeting on my desktop.
Barring being pre-empted by any breaking news, I'll have a scene-setter report tomorrow morning on "Squawk on the Street" at about 10:10am ET. And then when the vote comes down later in the day, we'll break in with it.
Dr. Perlmutter today perhaps summed it up best. "This is a complicated story," he said.
Questions? Comments?
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