Joe Podolski's presentation at BT Alex. Brown Health Care Conference today.
I had the privilege this afternoon at 5:30 to hear Joe P. put a master spin on today's debacle.
There was a brief summary of today's news followed by the canned roadshow presentation followed by a brief q&a. I'm going to try to recount the comments from my hastily scratched notes; there may be a few minor errors, especially with some of the dollar amts...
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THE SPIN
Joe P. was completely deferential to Schering (SGP). He stated that ZONA had the option to go to the FDA panel. This panel, he said, was the urology panel, one different from the one that Pfizer faced with Viagra, and a panel that in the past has approved only injectables for ED.
The choice apparently was to go to the panel, and, if rejected, face a year's wait before resubmission would be allowed versus accepting a non-acceptance of the NDA and be permitted to addend it in the future.
Joe P. stated that the FDA would not find ZONA's "pinnacle" 2 year long 2000 patient "open label" study acceptable for several reasons. The problems that he identified were that the study wasn't placebo controlled and that "end points" used were not going to be acceptable.
Joe P. stated that SGP was willing to support ZONA with whatever their decision was but that they strongly recommended putting off the panel appearance until they had more data available. SGP felt that the endpoints in the data that had been submitted to the FDA were NOT comparable to viagra's data.
Joe P. when asked about Zona's relationship NOW to SGP said "I think that it's stronger than ever". "Vasomax is now firmly entrenched as a Schering product." SGP is now doing all the manufacturing and conducting all the clinical trials. They are bearing 100% of the Vasomax costs in persuing the NDA and NOT using a CRO.
Numerous times he said, "Hey these are Schering's recommendations and who are we not to listen. Who has more experience going before the FDA? Who did the brilliant marketing for Claritin? If Schering says we don't have the data to win market share against Viagra, we better listen."
He defended to oft mentioned and questioned 69% efficacy rate as being accurate but was not clear whether the rate included dropouts.
Schering has already begun enrollment of new trials. These will be 12 week trials comparable to Pfizer's 12 week Viagra trials and draw efficacy and safety data from these trials. Joe P. implied that SGP wants to toss out the open label trial data.
Apparantly Schering will complete the trials and send to data to Zonagen for NDA amendment to FDA. The target date will be in December or January with hopes of a panel appearance in March or June 2000.
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The Q&A was a softball session. Joe P. knew most of the questioners by first name.
When asked to comment on Mexican sales, he replied that the IMS data are of poor quality. He claimed that Mexican approval was based on Mexican data and that Schering could not use those data to adequately market against Viagra. He said something like "Hey if you were Schering, would use expend a lot of money in this scenario for a battle you couldn't win?"
(Jesse Eisenger in his TSC article on Feb 24 pointed out that in the fourth quarter of 1998, Zonagen rebated $4K of Mexican royalties back to SGP.)
Finally, Mr. P stated to date that Zonagen has received $20mm of the $57mm milestone payment package from SGP.
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The canned part discussed ZONA's "pipeline" and "research".
Zonagen is working on three products:
>>Vasofem: phentolamine for enhancement of female sexual response with trials planned for both oral and vaginal cream preps
>>Bimexes: oral combo drug for ed
>>ERxin: injectable Rx for ED
Of note is the fact that clinical trials for Bimexes and ERxin will occur in Mexico. Also the planned studies will pit the former against Viagra and the latter against Caverject. (Buena suerte, Zona!)
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And let's not forget some great press in the past year:
Fortune Magazine:
pathfinder.com
The Houston Press:
houston-press.com
houston-press.com
TheStreet.com:
thestreet.com
www3.techstocks.com.
thestreet.com
thestreet.com
Manuel Asensio:
asensio.com |
