"Results were not robust," is how the FDA summarized, or should we say dismissed, the pixantrone phase III study during the first review. The agency raised safety concerns about the drug too, pointing to sharply higher rates of neutropenia (low white blood cell counts) and evidence of pixantrone-induced cardiac toxicity, including heart failure.
Last year, FDA suggested to Cell Therapeutics that it study pixantrone in combination with other cancer drugs before initial approval. That's what Cell Therapeutics is doing right now with the new, ongoing phase III study, which combines pixantrone with Roche's Rituxan.
Given pixantrone's many shortcomings and the overwhelming rejection last year, it would be shocking and unprecedented for the FDA to reverse course and approve the drug without new clinical data.
A couple of more tidbits: On the third-quarter conference call Tuesday, Bianco let it slip that enrollment in the new pixantrone study was slower than expected. That's another Bianco boast busted. Earlier this spring, Bianco said demand from U.S doctors to enroll patients in the pixantrone study was unprecedented, which would help the company reach full enrollment in record time. I guess not.Second, Cell Therapeutics followed up its third-quarter report by filing a new $100 million shelf registration statement with the SEC. Like I said before, it's always about raising money for Bianco and Cell Therapeutics.
@yemoko asks, "Is the dream over for Fanapt? What do you make of their new hire?" I have a hunch Novartis (NVS - Get Report) is getting ready to give up on the schizophrenia drug Fanapt due to rock-bottom sales, leaving partner Vanda Pharmaceuticals (VNDA - Get Report) with a major headache. I'm just speculating, admittedly, but hear me out. On Monday, Vanda announced the hiring of a chief commercial officer. On Tuesday, Novartis announced third-quarter financial results, which quite conspicuously excluded any mention of Fanapt sales. Vanda owns Fanapt but licensed U.S. marketing rights to Novartis in exchange for royalties on sales. Vanda sells no drugs on its own and isn't close to being in a position to sell drugs, so why is the company hiring a chief commercial officer? Unless Vanda knows that Novartis is about to abandon Fanapt at its doorstep.