conference date: March 13, 2008 @ 8:00 AM Pacific Time
for quarter ending: December 31, 2007 (4th quarter)
Overview: Still waiting for results of current Provenge trial, but FDA has agreed to move up date for that. Much discussion of fine points of trial statistics.
Revenue was $28,000.
Net loss was $27 million.
EPS loss was $0.32 million.
$120.6 million in cash and equivalents.
Interim results of Provenge Impact trial are still expected in the 2nd half of 2008, but final results are now expected in 2009. Positive results at either of these points should lead to FDA approval.
Keeping cash expenditures as low as possible and concentrating all effort on Provenge approval.
Planning PO7-1 localized prostate cancer with Provenge prior to surgery, about 40 patients.
PO7-2 120 patients with same criteria as Impact study, all receiving active therapy, but with different levels of activity.
Dendreon has access to immune targets for a variety of cancers.
Amended Special Protocol Assessment (SPA) amendment accelerates the Phase III study of Provenge for men with prostate cancer. Now need only 304 death events for final analysis, but maintained statistical power.
If results for Impact interim data are in line with prior trials, it meets the criteria the FDA has set for approval. But final analysis has a higher likelihood of meeting the criteria.
$80 million cash expense expected in 2008. Some expenses of 2007 have been delayed into 2008, in particular production of Provenge inventory.
More events in interim analysis? Yes, while decreasing alpha-spending function. Power for interim increased slightly, while final power stayed the same (88%).
When in 2009? 2nd half of 2009 for final analysis.
Any boosting trials? PO7-1 allows follow up with randomization for getting a boost or not, with boost at 3 months.
Loss from tail of curve for statistical significance by shortening trial? IMPACT trial started in August 2003, so we have had plenty of time to follow up patients. Immunotherapies take a while to ramp up immune system, but are more durable after that.
A key component of the 2 new studies is to allow patients with late-state prostate cancer access to this therapy.
Partnering outside U.S.? Seeking advice from EMEA.
Have not given number of events for interim analysis. If we see the same treatment effect as from prior trials, we expect to meet the endpoints for approval.
Interim analysis is done by independent committee (IDMC). Will share promptly with investment community. Interim analysis is like a free shot on goal. Not having the statistical power to pass on the interim does not mean we won't pass on the final analysis. The later you do the interim analysis and later you do it, the closer you are to your final in significance.
Are new trials a response to a specific question from the FDA? These are not a response to FDA. They are Dendreon initiated studies. We have a facility to create Provenge, this use helps keep the facility in a validated state. Data will not be part of amendment to current BLA; they won't be completed at that time.
D9901 interim analysis? No formal interim analysis in 9901 or 9902. Combined 9901 & 9902 final had only 164 events. So our interim will have a lot more events than the combined earlier studies. Impact study also going on longer, since August 2003. We did see a treatment effect in 9901 beginning at about 10 months.
High R&D spend in Q4? Actually a reclassification of expenses that were G&A in prior quarters. So R&D will go down going forward.
Doesn't reducing the number of events for the final decrease the chances that it will be statistically significant? The real question is, what is the treatment effect? Then how many events do you need to reach statistical significance. We lowered the bar we were required to meet for significance (in agreement with FDA).
Biotech failures historically from projecting non-controlled Phase 2 data to controll data in Phase 3. We have double-blind, controlled data from two Phase 3 studies that are very well studied that are being projected to a larger Phase 3 study.
Occurence of events has matched curves from 9901 and 9902. No acceleration of death events.
Chemotherapy? Provenge and chemotherapy seem to work well together.
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