With earnings season a virtual distant memory now for the health-care sector, we turn our attention to two major happenings set to take place on Thursday within the biotech arena: an FDA panel review of Theravance's (UNKNOWN:THRX.DL) Vibativ for the treatment of nosocomial pneumonia, and an FDA decision on approval for Exelixis' (NASDAQ:EXEL) experimental metastatic medullary thyroid cancer treatment, cabozantinib.
Deep-breath time for Theravance
For longtime Theravance shareholders, this moment is like deja vu -- if you think you've been here before, it's because you have. Back in 2009, Theravance completed late-stage clinical trials with Vibativ for nosocomial pneumonia, or NP, which met the primary endpoint, only to have the FDA change the primary endpoint focus in 2010 to reduction of the mortality rate, which Vibativ didn't meet based on that same study. Theravance did not actually conduct any additional trials, as the FDA originally requested, but instead got an FDA notification in September that its Anti-Infective Drugs Advisory Committee would review the drug on Nov. 29.
If recommended by the FDA panel and eventually approved, Vibativ will have a myriad of competitors to attempt to unseat, including Pfizer's (NYSE:PFE) Zyvox, and ViroPharma's (UNKNOWN:VPHM.DL) Vancomycin, as well as numerous other generic competitors. Furthermore, despite holding the sole rights to Vibativ worldwide, Theravance has only one third-party supplier manufacturing the drug, which has already led to shortages and caused the European Commission to suspend marketing authorization of Vibativ in May because it didn't meet good manufacturing requirements. This definitely sounds like a case where getting the approval will ultimately be just half the battle.
Do-or-die time for Exelixis
For Exelixis, this will be an interesting week to say the least. The biotech was originally scheduled to bring cabozantinib before an FDA panel on Nov 8 and 9 but was told in August that its meeting had been cancelled, yet its PDUFA date hasn't been changed from Nov. 29. Clearly, this has sent bulls and bears darting in opposite directions as to who is right.
The optimists only need to look at the data for cabozantinib to be feel good about its chances for FDA approval. In late-stage trails, cabozantinib helped extend median progression-free survival, or PFS, to 11.2 months, compared with just four months for the placebo -- that's huge! In addition, the overall response rate for the cabozantinib arm was 28%, compared with 0% for the placebo arm. Perhaps most importantly, the adverse side effects for cabozantinib were relatively mild, leading some to believe an approval is in the offing for this severely unmet treatment area of metastatic medullary thyroid cancer.
For pessimists, all they need to do is look at the FDA's pullback on its original panel date and note the failure during late-stage trials of ArQule's (NASDAQ:ARQL) tivantinib, which works through the c-Met pathway, similar to how cabozantinib works. Now, in all fairness, tivantinib, which was being tested on non-small-cell lung cancer, failed to improve overall survival rates in patients, and ArQule pulled the plug. Cabozantinib, on the other hand, showed dramatic PFS improvement. Still, doubt exists regarding cabozantinib's future considering the recent failure of tivantinib.
Both decisions are due out this coming Thursday, Nov. 29, so keep your eyes peeled.
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