From Alex S.: "Why, and under what circumstances, would a company release important Phase III trial data only after they submit a new drug application for their product?"
Raj C. asks, "Is Cell Genesys ( CEGE) pretty much finished after the FDA-ordered halt of its Phase III clinical trial for GVAX? Or does it have other promising drugs in the pipeline?" I usually spend a good bit of Wednesday afternoon writing the Mailbag, so this is what I typed in response to Raj's email:
Cell Genesys is pretty much finished because its GVAX cancer vaccine technology doesn't work. That's been my humble opinion for a long time, but a pretty good one, it turns out, after the company was forced to halt one of its prostate cancer vaccine trials in August due to more deaths attributable to GVAX Prostate. The next shoe to drop (again, my humble opinion) will be the halt to the other GVAX Prostate study dubbed VITAL-1. A futility analysis for this study is being conducted which will show that GVAX Prostate has no chance of improving survival over the control arm in which patients are receiving the chemo drug Taxotere. Cell Genesys' partner, the Japanese drug firm Takeda, will then file for divorce. After that, Cell Genesys will most definitely be done.After writing the above Wednesday, it amused me to no end to wake up Thursday morning to the news that Cell Genesys was shutting down the VITAL-1 study because GVAX Prostate doesn't work.
Today's last email from Vitas. "Adam, since Epicept ( EPCT) got European approval for Ceplene, what is your opinion of their prospects?" Persistence pays off. For those not familiar with the history here, Ceplene was once owned by Maxim Pharmaceuticals, a San Diego drug firm with a less-than-stellar reputation. Ceplene was a two-time failure in melanoma, but Maxim believed the drug had a future as a remission extender for patients with acute myeloid leukemia (AML).
One more note: After my Onyx Pharmaceuticals ( ONXX) item in last week's Mailbag, I heard from the company's head of investor relations Julie Wood that the company, on the second-quarter conference call, raised sales guidance for Nexavar to a range of $660 million to $675 million. In my column, I had the current guidance at $600 million to $650 million, so my mistake. The consensus Nexavar sales estimate for the third quarter remains in the $175 million range.