To put the upcoming TH-302 survival data in perspective, Tarceva in combination with gemcitabine is approved for the treatment of pancreatic cancer based on a phase III study that showed a median overall survival of 6.4 months versus 6 months for gemcitabine alone.
The most significant knock against the TH-302 PFS benefit observed in the phase II pancreatic cancer study to date is that there were some imbalances in patients' baseline criteria that favored TH-302 and could have skewed results. Sally Church of Pharma Strategy Blog had a good post last April describing the TH-302 data and the concerns. Definitely give Sally's perspective a read.
When it comes to Threshold and pancreatic cancer, also keep in mind that Celgene (CELG) is expected to announce results soon from a phase III study comparing Abraxane/gemcitabine versus gemcitabine alone. I mentioned Clovis' study above, too.
Saul K. asks, "Good morning, sir. Do you see any future or hope for Aeterna Zentaris (AEZS) or Keryx Biopharmaceuticals? So far, you have been right in your predictions." With the dissolution of the perifosine partnership, you can now look at Aeterna and Keryx as separate stocks now. Aeterna has no future. I'm not talking about the stock trading pennies up or down based on press releases or speculation. Sure, that's going to happen. But from a fundamental perspective, Aeterna is a dead end. The company's drug pipeline has produced one failure after another. What would lead anyone to believe that Aeterna is capable of breaking out of its drug development slump? Keryx Pharmaceuticals may get a near-term trading bump if results are positive from the phase III long-term study of Zerenex, its phosphate binder for use in dialysis patients. [Data expected in the fourth quarter.] Zerenex is going to be commercial dud, however. Keryx will find it exceedingly difficult to find any dialysis centers willing to buy Zerenex in a Medicare fee-bundled reimbursement environment. Others have tried and failed. Remember Amag Pharmaceuticals?
Mahoney writes, "You are pathetic. You are either intelligent and use that to provide garbage to your idiot followers and profit on the market's reaction which should be illegal and you in jail with Big Bubba, or you are just plain ignorant... PPHM" Wow, run-on sentence!
@Atip4 asks, "Rumor spreading $EXEL's cabo will be approved for thyroid this week. Have you heard anything?" No, although I may have played a role in propagating the speculation. I mentioned Exelixis (EXEL) and its thyroid cancer drug cabozantinib as possible early approval candidates in a column last week. My reasoning? Not much more than FDA seems to be approving drugs with alacrity in recent weeks and the agency did cancel an advisory panel meeting for cabozantinib that was scheduled for Nov. 9. If I were a betting guy, I'd say Ariad Pharmaceuticals (ARIA) has a better shot winning early approval for its leukemia drug ponatinib than Exelixis does with cabozantinib. Ponatinib better fits the profile of a drug that FDA could fast track through the review process. While on Exelixis, make sure you read Tony Pelz's column on how to trade the stock using options. --Written by Adam Feuerstein in Boston.
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